Cosmetic Labeling Attachment C 21CFR701

Food and Drug Administration, HHS

§ 701.1

regulations without regard to the retail level effective date.
[47 FR 50451, Nov. 5, 1982; 48 FR 1707, Jan. 14,
1983; 48 FR 11427, Mar. 18, 1983, as amended at
48 FR 16664, Apr. 19, 1983; 48 FR 37624, Aug. 19,
1983]
EFFECTIVE DATE NOTE: See 48 FR 41579,
Sept. 16, 1983, for a document announcing an
interim stay of the effective date of certain
provisions in paragraph (e)(3) of § 700.25.

§ 700.35 Cosmetics
containing
sunscreen ingredients.
(a) A product that includes the term
‘‘sunscreen’’ in its labeling or in any
other way represents or suggests that
it is intended to prevent, cure, treat, or
mitigate disease or to affect a structure or function of the body comes
within the definition of a drug in section 201(g)(1) of the act. Sunscreen active ingredients affect the structure or
function of the body by absorbing, reflecting, or scattering the harmful,
burning rays of the sun, thereby altering the normal physiological response
to solar radiation. These ingredients
also help to prevent diseases such as
sunburn and may reduce the chance of
premature skin aging, skin cancer, and
other harmful effects due to the sun
when used in conjunction with limiting
sun exposure and wearing protective
clothing. When consumers see the term
‘‘sunscreen’’ or similar sun protection
terminology in the labeling of a product, they expect the product to protect
them in some way from the harmful effects of the sun, irrespective of other
labeling statements. Consequently, the
use of the term ‘‘sunscreen’’ or similar
sun protection terminology in a product’s labeling generally causes the
product to be subject to regulation as a
drug. However, sunscreen ingredients
may also be used in some products for
nontherapeutic, nonphysiologic uses
(e.g., as a color additive or to protect
the color of the product). To avoid consumer misunderstanding, if a cosmetic
product contains a sunscreen ingredient and uses the term ‘‘sunscreen’’ or
similar sun protection terminology
anywhere in its labeling, the term
must be qualified by describing the
cosmetic benefit provided by the sunscreen ingredient.
(b) The qualifying information required under paragraph (a) of this sec-

tion shall appear prominently and conspicuously at least once in the labeling
in conjunction with the term ‘‘sunscreen’’ or other similar sun protection
terminology used in the labeling. For
example: ‘‘Contains a sunscreen—to
protect product color.’’
[64 FR 27693, May 21, 1999]

PART 701—COSMETIC LABELING
Subpart A—General Provisions
Sec.
701.1 Misbranding.
701.2 Form of stating labeling requirements.
701.3 Designation of ingredients.
701.9 Exemptions from labeling requirements.

Subpart B—Package Form
701.10 Principal display panel.
701.11 Identity labeling.
701.12 Name and place of business of manufacturer, packer, or distributor.
701.13 Declaration of net quantity of contents.

Subpart C—Labeling of Specific
Ingredients
701.20 Detergent substances, other than
soap, intended for use in cleansing the
body.
701.30 Ingredient names established for cosmetic ingredient labeling.
AUTHORITY: 21 U.S.C. 321, 352, 361, 362, 363,
371, 374; 15 U.S.C. 1454, 1455.
SOURCE: 39 FR 10056, Mar. 15, 1974, unless
otherwise noted.

Subpart A—General Provisions
§ 701.1 Misbranding.
(a) Among representations in labeling of a cosmetic which render such
cosmetic misbranded is a false or misleading representation with respect to
another cosmetic or a food, drug, or device.
(b) The labeling of a cosmetic which
contains two or more ingredients may
be misleading by reason (among other
reasons) of the designation of such cosmetic in such labeling by a name which
includes or suggests the name of one or
more but not all such ingredients, even
though the names of all such ingredients are stated elsewhere in the labeling.

135

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00135

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

§ 701.2

21 CFR Ch. I (4–1–04 Edition)

§ 701.2 Form of stating labeling requirements.
(a) A word, statement, or other information required by or under authority
of the Act to appear on the label may
lack that prominence and conspicuousness required by section 602(c) of the
Act by reason (among other reasons)
of:
(1) The failure of such word, statement, or information to appear on the
part or panel of the label which is presented or displayed under customary
conditions of purchase;
(2) The failure of such word, statement, or information to appear on two
or more parts or panels of the label,
each of which has sufficient space
therefor, and each of which is so designed as to render it likely to be,
under customary conditions of purchase, the part or panel displayed;
(3) The failure of the label to extend
over the area of the container or package available for such extension, so as
to provide sufficient label space for the
prominent placing of such word, statement, or information;
(4) Insufficiency of label space (for
the prominent placing of such word,
statement, or information) resulting
from the use of label space for any
word, statement, design, or device
which is not required by or under authority of the Act to appear on the
label;
(5) Insufficiency of label space (for
the prominent placing of such word,
statement, or information) resulting
from the use of label space to give materially greater conspicuousness to any
other word, statement, or information,
or to any design or device;
(6) Smallness or style of type in
which such word, statement, or information appears, insufficient background contrast, obscuring designs or
vignettes, or crowding with other written, printed, or graphic matter.
(b)(1) All words, statements, and
other information required by or under
authority of the Act to appear on the
label or labeling shall appear thereon
in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth
of Puerto Rico or in a Territory where
the predominant language is one other

than English, the predominant language may be substituted for English.
(2) If the label contains any representation in a foreign language, all words,
statements, and other information required by or under authority of the Act
to appear on the label shall appear
thereon in the foreign language.
(3) If the labeling contains any representation in a foreign language, all
words, statements, and other information required by or under authority of
the Act to appear on the label or labeling shall appear on the labeling in the
foreign language.
§ 701.3 Designation of ingredients.
(a) The label on each package of a
cosmetic shall bear a declaration of the
name of each ingredient in descending
order of predominance, except that fragrance or flavor may be listed as fragrance or flavor. An ingredient which
is both fragrance and flavor shall be
designated by each of the functions it
performs unless such ingredient is
identified by name. No ingredient may
be designated as fragrance or flavor unless it is within the meaning of such
term as commonly understood by consumers. Where one or more ingredients
is accepted by the Food and Drug Administration as exempt from public
disclosure pursuant to the procedure
established in § 720.8(a) of this chapter,
in lieu of label declaration of identity
the phrase ‘‘and other ingredients’’
may be used at the end of the ingredient declaration.
(b) The declaration of ingredients
shall appear with such prominence and
conspicuousness as to render it likely
to be read and understood by ordinary
individuals under normal conditions of
purchase. The declaration shall appear
on any appropriate information panel
in letters not less than 1⁄16 of an inch in
height and without obscuring design,
vignettes, or crowding. In the absence
of sufficient space for such declaration
on the package, or where the manufacturer or distributor wishes to use a
decorative container, the declaration
may appear on a firmly affixed tag,
tape, or card. In those cases where
there is insufficient space for such declaration on the package, and it is not
practical to firmly affix a tag, tape, or
card, the Commissioner may establish

136

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00136

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

Food and Drug Administration, HHS

§ 701.3

by regulation an acceptable alternate,
e.g., a smaller type size. A petition requesting such a regulation as an
amendment to this paragraph shall be
submitted pursuant to part 10 of this
chapter.
(c) A cosmetic ingredient shall be
identified in the declaration of ingredients by:
(1) The name specified in § 701.30 as
established by the Commissioner for
that ingredient for the purpose of cosmetic ingredient labeling pursuant to
paragraph (e) of this section;
(2) In the absence of the name specified in § 701.30, the name adopted for
that ingredient in the following editions and supplements of the following
compendia, listed in order as the
source to be utilized:
(i) CTFA (Cosmetic, Toiletry and
Fragrance Association, Inc.) Cosmetic
Ingredient Dictionary, Second Ed., 1977
(available from the Cosmetic, Toiletry
and Fragrance Association, Inc. 1110
Vermont Ave. NW., Suite 800, Washington, DC 20005, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC 20408),
which is incorporated by reference, except for the following deletions and revisions:
(a) The following names are not
adopted for the purpose of cosmetic ingredient labeling:
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid
Acid

Black 58
Black 107
Black 139
Blue 168
Blue 170
Blue 188
Blue 209
Brown 19
Brown 30
Brown 44
Brown 45
Brown 46
Brown 48
Brown 224
Orange 80
Orange 85
Orange 86
Orange 88
Orange 89
Orange 116
Red 131
Red 213
Red 252
Red 259
Violet 73
Violet 76

Acid Violet 99
Acid Yellow 114
Acid Yellow 127
Direct Yellow 81
Solvent Black 5
Solvent Brown 43
Solvent Yellow 63
Solvent Yellow 90

(b) The following names are adopted
for the purpose of cosmetic ingredient
labeling, provided the respective monographs are revised to describe their
otherwise disclosed chemical compositions, or describe their chemical compositions more precisely, and such revised monographs are published in supplements to this dictionary edition by
July 18, 1980.
Acid Black 2
Benzophenone-11
Carbomer 934
Carbomer 934P
Carbomer 940
Carbomer 941
Carbomer 960
Carbomer 961
Chlorofluorocarbon 11S
Dimethicone Copolyol
Disperse Red 17
Pigment Green 7
Polyamino Sugar Condensate
SD Alcohol (all 27 alphanumeric designations)
Sodium Chondroitin Sulfate
Synthetic Beeswax

(c) The following names are adopted
for the purpose of cosmetic ingredient
labeling until January 19, 1981.
Amphoteric (all 20 numeric designations)
Quaternium (all 49 numeric designations)

(ii) United States Pharmacopeia, 19th
Ed., 1975, and Second Supplement to
the USP XIX and NF XIV, 1976. (Copies
are
available
from
the
U.S.
Pharmacopeial Convention, Inc., 12601
Twinbrook Parkway, Rockville, MD
20852, or available for inspection at the
Office of the Federal Register, 800
North Capitol Street, NW., suite 700,
Washington, DC 20408.)
(iii) National Formulary, 14th Ed.,
1975, and Second Supplement to the
USP XIX and NF XIV, 1976. (Copies are
available from the U.S. Pharmacopeial
Convention, Inc., 12601 Twinbrook
Parkway, Rockville, MD 20852, or available for inspection at the Office of the
Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC
20408).

137

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00137

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

§ 701.3

21 CFR Ch. I (4–1–04 Edition)

(iv) Food Chemicals Codex, 2d Ed.,
1972; First Supplement, 1974, and Second Supplement, 1975, which are incorporated by reference. Copies are available from the Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or
available for inspection at the Office of
the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC
20408.
(v) USAN and the USP dictionary of
drug names, USAN 1975, 1961–1975 cumulative list. (Copies are available
from the U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Parkway,
Rockville, MD 20852, or available for inspection at the Office of the Federal
Register, 800 North Capitol Street,
NW., suite 700, Washington, DC 20408.)
(3) In the absence of such a listing,
the name generally recognized by consumers.
(4) In the absence of any of the above,
the chemical or other technical name
or description.
(d) Where a cosmetic product is also
an over-the-counter drug product, the
declaration shall declare the active
drug ingredients as set forth in
§ 201.66(c)(2) and (d) of this chapter, and
the declaration shall declare the cosmetic ingredients as set forth in
§ 201.66(c)(8) and (d) of this chapter.
(e) Interested persons may submit a
petition requesting the establishment
of a specific name for a cosmetic ingredient pursuant to part 10 of this chapter. The Commissioner may also propose such a name on his own initiative.
(f) As an alternative to listing all ingredients in descending order of predominance, ingredients may be grouped
and the groups listed in the following
manner and order:
(1) Ingredients, other than color additives, present at a concentration greater than 1 percent, in descending order
of predominance; followed by
(2) Ingredients, other than color additives, present at a concentration of not
more than 1 percent, without respect
to order of predominance; followed by
(3) Color additives, without respect
to order of predominance. Ingredients
specified in paragraph (f)(2) of this section may be included with those specified in paragraph (f)(1) of this section

and listed in descending order of predominance.
(g) A declaration of ingredients may
include an ingredient not in the product if the ingredient is identified by
the phrase ‘‘may contain’’ and:
(1) It is a color additive added to
some batches of the product for purposes of color matching; or
(2)(i) The same declaration of ingredients is also used for other products
similar in composition and intended
for the same use, including products
which may be assortments of products
similar in composition and intended
for the same use; and
(ii) Such products are ‘‘shaded’’ products, i.e., those falling within the product categories identified in § 720.4 (c)(3),
(7) and (8)(v) of this chapter; and
(iii) All products sharing the common
declaration of ingredients are sold by
the labeler under a common trade
name or brand designation, and no
trade name or brand designation not
common to all such products appears
in the labeling of any of them; and
(iv) The ingredient is a color additive.
(h) As an alternative to a declaration
of color additive ingredients for each
product, the color additives of an assortment of cosmetic products that are
sold together in the same package may
be declared in a single composite list in
a manner that is not misleading and
that indicates that the list pertains to
all the products.
(i) As an alternative to the declaration of ingredients specified in paragraph (b) of this section, the declaration of ingredients may appear in letters not less than 1⁄16 of an inch in
height in labeling accompanying the
product, as for example, on padded
sheets or in leaflets, if the total surface
area of the package is less than 12
square inches. This paragraph is inapplicable to any packaged cosmetic
product enclosed in an outer container,
e.g., a folding carton. In addition, this
paragraph is applicable only to cosmetic products meeting one of the following requirements:
(1) The cosmetic products are held
and displayed for sale in tightly compartmented trays or racks of a display
unit. The holder of the labeling bearing

138

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00138

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

Food and Drug Administration, HHS

§ 701.3

the declaration of ingredients shall be
attached to the display unit; or
(2) The cosmetic products are
‘‘shaded’’ products, i.e., those falling
within the product categories identified in § 720.4 (c)(3), (7) and (8)(v) of this
chapter, and are held for sale in tightly
compartmented trays or racks. The
holder of the labeling bearing the declaration of ingredients shall be attached to a display chart bearing samples of the product shades, which is displayed to purchasers. Such a display
chart shall be of such construction and
design as to permit its continuous use
as a display, such as on a counter, and
shall be designed for the primary purpose of displaying samples of the
shades of the products.
(j) The holder of labeling bearing a
declaration of ingredients and used in
accordance with paragraph (i) of this
section shall be attached to the display
unit or chart and shall meet one of the
following conditions:
(1) The labeling is on the front of the
display unit or chart and can be read in
full by a purchaser facing the display
unit or chart under customary conditions of retail sale; or
(2) The labeling is on the front of the
display unit or chart, is partially visible, and is accompanied by a conspicuous notice on the front of the display unit or chart describing the location of such labeling in letters not less
than 3⁄16 of an inch in height, e.g., ‘‘Ingredient lists above’’, that can be read
by a purchaser facing the display unit
or chart under customary conditions of
retail sale, or by the notice required by
provisions in paragraph (k)(3) of this
section, if conspicuous at all times; or
(3) The labeling is on a side of the
display unit or chart, but not on the
top, back, or bottom, and is accompanied by a conspicuous notice on the
front of the display unit or chart describing the location of such labeling
in letters not less than 3⁄16 of an inch in
height, e.g., ‘‘Ingredient lists located
on right side of display’’, that can be
read by a purchaser facing the display
unit or chart under customary conditions of retail sale.
(k) Any use of a display unit or chart
bearing labeling under the provisions
of paragraph (i) of this section shall
meet the following requirements:

(1) All articles of labeling bearing ingredient declarations and used in conjunction with any one display unit or
chart shall be identical and shall declare the ingredients of all products
sold in conjunction with the display
unit or chart for which the ingredient
declaration is made pursuant to paragraph (i) of this section.
(2) Any display unit or chart intended for such use shall be shipped together with the labeling intended to be
attached to it.
(3) Every display unit or chart and/or
labeling system shall be designed so
that the words ‘‘Federal law requires
ingredient lists to be displayed here’’
in letters not less than 3⁄16 of an inch in
height (i) become conspicuous when no
ingredient declarations are displayed
and when the last list has been taken,
or (ii) are conspicuous at all times adjacent to the place where ingredient
declarations are to be attached.
(4) Any labeling containing a declaration of ingredients which reflects a formulation change and not shipped accompanying a display unit or chart
shall be dated. Whenever any formulation change is made, and the labeling
containing the declaration of ingredients is thereby required to be used in
conjunction with products of both the
old and new formulations, the labeling
shall declare the ingredients of both
the old and new formulations separately in a way that is not misleading
and in a way that permits the purchaser to identify the ingredient declaration applicable to each package, or
which clearly advises the purchaser
that the formulation has been changed
and that either declaration may be applicable.
(5) Sufficient copies of the declaration of ingredients shall be provided
with each shipment of a cosmetic so
that a purchaser may obtain a copy of
the declaration with each purchase.
Display units and replacement labeling
for display units shall be accompanied
by instructions to the retailer, which
when followed will result in compliance with the requirements of this section. Copies of the declaration accompanying refills shall be attached to the
specific refill items to which they pertain, or shall be packed with the specific refill items to which they pertain,

139

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00139

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

§ 701.3

21 CFR Ch. I (4–1–04 Edition)

in a container that does not contain
other cosmetic products.
(6) The firm whose name appears on a
product pursuant to § 701.12 shall
promptly mail a copy of the declaration of ingredients to any person requesting it.
(7) The display unit or chart shall be
designed and located such that the labeling is easily accessible to a purchaser facing the display unit or chart
under customary conditions of retail
sale.
(l) The provisions of this section do
not require the declaration of incidental ingredients that are present in a
cosmetic at insignificant levels and
that have no technical or functional effect in the cosmetic. For the purpose of
this paragraph, incidental ingredients
are:
(1) Substances that have no technical
or functional effect in the cosmetic but
are present by reason of having been
incorporated into the cosmetic as an
ingredient of another cosmetic ingredient.
(2) Processing aids, which are as follows:
(i) Substances that are added to a
cosmetic during the processing of such
cosmetic but are removed from the cosmetic in accordance with good manufacturing practices before it is packaged in its finished form.
(ii) Substances that are added to a
cosmetic during processing for their
technical or functional effect in the
processing, are converted to substances
the same as constituents of declared
ingredients, and do not significantly
increase the concentration of those
constituents.
(iii) Substances that are added to a
cosmetic during the processing of such
cosmetic for their technical and functional effect in the processing but are
present in the finished cosmetic at insignificant levels and do not have any
technical or functional effect in that
cosmetic.
(m) In the event that there is a current or anticipated shortage of a cosmetic ingredient, the declaration required by this section may specify alternatives to any ingredients that may
be affected. An alternative ingredient
shall be declared either (1) immediately following the normally used in-

gredient for which it substitutes, in
which case it shall be identified as an
alternative ingredient by the word
‘‘or’’ following the name of the normally used ingredient and any other alternative ingredient, or (2) following
the declaration of all normally used ingredients, in which case the alternative
ingredients in the group so listed shall
be listed in expected descending order
of predominance or in accordance with
the provisions of paragraph (f) of this
section and shall be identified as alternative ingredients by the phrase ‘‘may
also contain’’. This paragraph is inapplicable to any ingredient mentioned
in advertising, or in labeling other
than in the declaration of ingredients
required by this section.
(n) In the event that the shortage of
a cosmetic ingredient necessitates a
formulation change, packages bearing
labels declaring the ingredients of the
old formulation may be used if the revised ingredient declaration appears (1)
on a firmly affixed tag, tape, card, or
sticker or similar overlabeling attached to the package and bearing the
conspicuous words ‘‘new ingredient
list’’ in letters not less than 1⁄16 of an
inch in height, or (2) on labeling inside
an unsealed package and the package
bears the conspicuous words, on a
sticker or similar overlabeling, ‘‘new
ingredient list inside’’ in letters not
less than 1⁄16 of an inch in height.
(o) The ingredients of products that
are similar in composition and intended for the same use may be declared as follows:
(1) The declaration of ingredients for
an assortment of such products that
are sold together in the same package,
e.g., eyeshadows of different colors,
may declare the ingredients that are
common to all the products, in a single
list in their cumulative order of predominance or in accordance with the
provisions of paragraph (f) of this section, together with a statement, in
terms that are as informative as practicable and that are not misleading, declaring the other ingredients and identifying the products in which they are
present. The color additive ingredients
of all the products in such an assortment, whether or not common to all

140

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00140

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

Food and Drug Administration, HHS

§ 701.3

the products, may be declared in a single composite list following the declaration of the other ingredients without identifying the products in which
they are present.
(2) The ingredients of an assortment
of such products that are sold together
in the same package, e.g., eyeshadows
of different colors, may be declared in
a single list in their cumulative order
of predominance or in accordance with
the provisions of paragraph (f) of this
section, if the package is designed such
that it has a total surface area available to bear labeling of less than 12
square inches. For the purpose of this
paragraph, surface area is not available
for labeling if physical characteristics
of the package surface, e.g., decorative
relief, make application of a label impractical.
(3) The declaration of ingredients for
such a product that is individually
packaged and bears a label that is
shared with other products pursuant to
the provisions of paragraph (g)(2) of
this section, e.g., one lipstick in a line
of lipsticks, may declare the ingredients that are common to all such products, in a single list in their cumulative order of predominance or in accordance with the provisions of paragraph (f) of this section, together with
a statement, in terms that are as informative as practicable and that are
not misleading, declaring the other ingredients in such products, and identifying the products in which they are
present. The color additive ingredients
shall be declared in accordance with
the provisions of paragraph (g) of this
section.
(4) The declaration of ingredients for
an assortment of such cosmetic products that bears a label that is shared
with other products pursuant to the
provisions of paragraph (g)(2) of this
section, e.g., one of several compacts in
a line of compacts, may declare the ingredients that are common to all such
products, in a single list in their cumulative order of predominance or in accordance with the provisions of paragraph (f) of this section, together with
a statement, in terms that are as informative as practicable and that are
not misleading, declaring the other ingredients in such products and identifying the products in which they are

present. The color additive ingredients
shall be declared in accordance with
the provisions of paragraph (g) of this
section.
(p) As an alternative to the declaration of ingredients in letters not less
than 1⁄16 of an inch in height, letters
may be not less than 1⁄32 of an inch in
height if the package is designed such
that it has a total surface area available to bear labeling of less than 12
square inches. For the purpose of this
paragraph, surface area is not available
for labeling if physical characteristics
of the package surface, e.g., decorative
relief, make application of a label impractical.
(q) The inside containers in a multiunit or multicomponent retail cosmetic package are not required to bear
a declaration of ingredients when the
labeling of the multiunit or multicomponent retail cosmetic package
meets all the requirements of this section and the inside containers are not
intended to be, and are not customarily, separated from the retail package for retail sale.
(r) In the case of cosmetics distributed to the consumers by direct mail,
as an alternative to the declaration of
ingredients on an information panel,
the declaration of ingredients may appear in letters not less than 1⁄16 of an
inch in height in labeling that accompanies and specifically relates to the
cosmetic(s) mailed, or in labeling furnished to each consumer for his personal use and from which he orders cosmetics through the mail, e.g., a direct
mail sales catalog or brochure, provided all of the following additional requirements are met:
(1) The declarations of ingredients
are conspicuous and presented in a way
that permits the consumer to identify
the declaration of ingredients applicable to each cosmetic.
(2) The package mailed to the consumer is accompanied by a notice located on, or affixed to, the top of the
package or on top of the contents inside the package, or on the face of the
package platform surrounding and
holding the product(s), readily visible
to the consumer on opening of the
package, and provides the following information in letters not less than 3⁄16 of
an inch in height:

141

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00141

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

§ 701.9

21 CFR Ch. I (4–1–04 Edition)

(i) The location of the declarations of
ingredients, e.g., in an accompanying
brochure, or in a sales catalog used for
ordering;
(ii) A statement that a copy of the
declaration of ingredients will be
mailed promptly to any person requesting it; and
(iii) The name and place of business
of the mail order distributor,
(3) The mail order distributor
promptly mails a copy of the declaration of ingredients to any person requesting it.
[39 FR 10056, Mar. 15, 1974, as amended at 40
FR 8922, Mar. 3, 1975; 40 FR 18426, Apr. 28,
1975; 42 FR 4718, Jan. 25, 1977; 42 FR 15676,
Mar. 22, 1977; 42 FR 24255, May 31, 1977; 42 FR
46516, Sept. 16, 1977; 42 FR 61257, Dec. 2, 1977;
45 FR 3577, Jan. 18, 1980; 47 FR 9397, Mar. 5,
1982; 54 FR 24900, June 12, 1989; 64 FR 13297,
Mar. 17, 1999]

§ 701.9 Exemptions from labeling requirements.
(a) Except as provided by paragraphs
(b) and (c) of this section, a shipment
or other delivery of a cosmetic which
is, in accordance with the practice of
the trade, to be processed, labeled, or
repacked in substantial quantity at an
establishment other than that where
originally processed or packed, shall be
exempt, during the time of introduction into and movement in interstate
commerce and the time of holding in
such establishment, from compliance
with the labeling requirements of sections 601(a) and 602(b) of the act if:
(1) The person who introduced such
shipment or delivery into interstate
commerce is the operator of the establishment where such cosmetic is to be
processed, labeled, or repacked; or
(2) In case such person is not such operator, such shipment or delivery is
made to such establishment under a
written agreement, signed by and containing the post office addresses of
such person and such operator, and
containing such specifications for the
processing, labeling, or repacking, as
the case may be, of such cosmetic in
such establishment as will insure, if
such specifications are followed, that
such cosmetic will not be adulterated
or misbranded within the meaning of
the act upon completion of such processing, labeling, or repacking. Such
person and such operator shall each

keep a copy of such agreement until 2
years after the final shipment or delivery of such cosmetic from such establishment, and shall make such copies
available for inspection at any reasonable hour to any officer or employee of
the Department who requests them.
(b) An exemption of a shipment or
other delivery of a cosmetic under
paragraph (a)(1) of this section shall, at
the beginning of the act of removing
such shipment or delivery, or any part
thereof, from such establishment, become void ab initio if the cosmetic
comprising such shipment, delivery, or
part is adulterated or misbranded within the meaning of the act when so removed.
(c) An exemption of a shipment or
other delivery of a cosmetic under
paragraph (a)(2) of this section shall
become void ab initio with respect to
the person who introduced such shipment or delivery into interstate commerce upon refusal by such person to
make available for inspection a copy of
the agreement, as required by such
clause.
(d) An exemption of a shipment or
other delivery of a cosmetic under
paragraph (a)(2) of this section shall
expire:
(1) At the beginning of the act of removing such shipment or delivery, or
any part thereof, from such establishment if the cosmetic comprising such
shipment, delivery, or part is adulterated or misbranded within the meaning
of the act when so removed; or
(2) Upon refusal by the operator of
the establishment where such cosmetic
is to be processed, labeled, or repacked,
to make available for inspection a copy
of the agreement, as required by such
clause.

Subpart B—Package Form
§ 701.10 Principal display panel.
The term principal display panel as it
applies to cosmetics in package form
and as used in this part, means the part
of a label that is most likely to be displayed, presented, shown, or examined
under customary conditions of display
for retail sale. The principal display
panel shall be large enough to accommodate all the mandatory label information required to be placed thereon

142

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00142

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

Food and Drug Administration, HHS

§ 701.12

by this part with clarity and conspicuousness and without obscuring designs,
vignettes, or crowding. Where packages
bear alternate principal display panels,
information required to be placed on
the principal display panel shall be duplicated on each principal display
panel. For the purpose of obtaining
uniform type size in declaring the
quantity of contents of all packages of
substantially the same size, the term
‘‘area of the principal display panel’’
means the area of the side or surface
that bears the principal display panel,
which area shall be:
(a) In the case of a rectangular package where one entire side properly can
be considered to be the principal display panel side, the product of the
height times the width of that side;
(b) In the case of a cylindrical or
nearly cylindrical container, 40 percent
of the product of the height of the container times the circumference; and
(c) In the case of any other shape of
container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious ‘‘principal display
panel’’ such as the top of a triangular
or circular package, the area shall consist of the entire top surface.
In determining the area of the principal display panel, exclude tops, bottoms, flanges at the tops and bottoms
of cans, and shoulders and necks of bottles or jars. In the case of cylindrical
or nearly cylindrical containers, information required by this part to appear
on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be
displayed, presented, shown, or examined under customary conditions of display for retail sale.
§ 701.11 Identity labeling.
(a) The principal display panel of a
cosmetic in package form shall bear as
one of its principal features a statement of the identity of the commodity.
(b) Such statement of identity shall
be in terms of:
(1) The common or usual name of the
cosmetic; or
(2) An appropriately descriptive name
or, when the nature of the cosmetic is
obvious, a fanciful name understood by
the public to identify such cosmetic; or

(3) An appropriate illustration or vignette representing the intended cosmetic use.
(c) The statement of identity shall be
presented in bold type on the principal
display panel, shall be in a size reasonably related to the most prominent
printed matter on such panel, and shall
be in lines generally parallel to the
base on which the package rests as it is
designed to be displayed.
§ 701.12 Name and place of business of
manufacturer,
packer,
or
distributor.
(a) The label of a cosmetic in package form shall specify conspicuously
the name and place of business of the
manufacturer, packer, or distributor.
(b) The requirement for declaration
of the name of the manufacturer, packer, or distributor shall be deemed to be
satisfied in the case of a corporation
only by the actual corporate name,
which may be preceded or followed by
the name of the particular division of
the corporation. Abbreviations for
‘‘Company,’’ ‘‘Incorporated,’’ etc., may
be used and ‘‘The’’ may be omitted. In
the case of an individual, partnership,
or association, the name under which
the business is conducted shall be used.
(c) Where the cosmetic is not manufactured by the person whose name appears on the label, the name shall be
qualified by a phrase that reveals the
connection such person has with such
cosmetic; such as, ‘‘Manufactured for
lllllll’’,
‘‘Distributed
by
llllllll’’, or any other wording
that expresses the facts.
(d) The statement of the place of
business shall include the street address, city, State, and ZIP Code; however, the street address may be omitted
if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP
Code shall apply only to consumer
commodity labels developed or revised
after the effective date of this section.
In the case of nonconsumer packages,
the ZIP Code shall appear either on the
label or the labeling (including the invoice).
(e) If a person manufactures, packs,
or distributes a cosmetic at a place
other than his principal place of business, the label may state the principal

143

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00143

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

§ 701.13

21 CFR Ch. I (4–1–04 Edition)

place of business in lieu of the actual
place where such cosmetic was manufactured or packed or is to be distributed, unless such statement would be
misleading.
§ 701.13 Declaration of net quantity of
contents.
(a) The label of a cosmetic in package form shall bear a declaration of the
net quantity of contents. This shall be
expressed in terms of weight, measure,
numerical count, or a combination of
numerical count and weight or measure. The statement shall be in terms of
fluid measure if the cosmetic is liquid
or in terms of weight if the cosmetic is
solid, semisolid, or viscous, or a mixture of solid and liquid. If there is a
firmly established, general consumer
usage and trade custom of declaring
the net quantity of a cosmetic by numerical count, linear measure, or
measure of area, such respective term
may be used. If there is a firmly established, general consumer usage and
trade custom of declaring the contents
of a liquid cosmetic by weight, or a
solid, semisolid, or viscous cosmetic by
fluid measure, it may be used. Whenever the Commissioner determines for
a specific packaged cosmetic that an
existing practice of declaring net quantity of contents by weight, measure,
numerical count, or a combination of
these does not facilitate value comparisons by consumers, he shall by regulation designate the appropriate term
or terms to be used for such cosmetic.
(b) Statements of weight shall be in
terms of avoirdupois pound and ounce.
Statements of fluid measure shall be in
terms of the U.S. gallon of 231 cubic
inches and quart, pint, and fluid-ounce
subdivisions thereof and shall express
the volume at 68 °F. (20 °C.).
(c) When the declaration of quantity
of contents by numerical count, linear
measure, or measure of area does not
give accurate information as to the
quantity of cosmetic in the package, it
shall be augmented by such statement
of weight, measure, or size of the individual units or the total weight or
measure of the cosmetic as will give
such information.
(d) The declaration may contain
common or decimal fractions. A common fraction shall be in terms of

halves, quarters, eighths, sixteenths, or
thirty-seconds; except that if there exists a firmly established, general consumer usage and trade custom of employing different common fractions in
the net quantity declaration of a particular commodity they may be employed. A common fraction shall be reduced to its lowest terms; a decimal
fraction shall not be carried out to
more than two places. A statement
that includes small fractions of an
ounce shall be deemed to permit smaller variations than one which does not
include such fractions.
(e) The declaration shall be located
on the principal display panel of the
label; with respect to packages bearing
alternate principal display panels, it
shall be duplicated on each principal
display panel: Provided, That:
(1) The principal display panel of a
cosmetic marketed in a ‘‘boudoir-type’’
container including decorative cosmetic containers of the ‘‘cartridge,’’
‘‘pill box,’’ ‘‘compact,’’ or ‘‘pencil’’ variety, and those with a capacity of onefourth ounce or less, may be considered
to be a tear-away tag or tape affixed to
the decorative container and bearing
the mandatory label information as required by this part, but the type size of
the net quantity of contents statement
shall be governed by the dimensions of
the decorative container; and
(2) The principal display panel of a
cosmetic marketed on a display card to
which the immediate container is affixed may be considered to be the display panel of the card, and the type
size of the net quantity of content
statement is governed by the dimensions of the display card.
(f) The declaration shall appear as a
distinct item on the principal display
panel, shall be separated (by at least a
space equal to the height of the lettering used in the declaration) from
other printed label information appearing above or below the declaration and
(by at least a space equal to twice the
width of the letter ‘‘N’’ of the style of
type used in the quantity of contents
statement) from other printed label information appearing to the left or right
of the declaration. It shall not include
any term qualifying a unit of weight,
measure, or count (such as ‘‘giant
pint’’ and ‘‘full quart’’) that tends to

144

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00144

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

Food and Drug Administration, HHS

§ 701.13

exaggerate the amount of the cosmetic
in the container. It shall be placed on
the principal display panel within the
bottom 30 percent of the area of the
label panel in line generally parallel to
the base on which the package rests as
it is designed to be displayed: Provided,
That:
(1) On packages having a principal
display panel of 5 square inches or less,
the requirement for placement within
the bottom 30 percent of the area of the
label panel shall not apply when the
declaration of net quantity of contents
meets the other requirements of this
part; and
(2) In the case of a cosmetic that is
marketed with both outer and inner retail containers bearing the mandatory
label information required by this part,
and the inner container is not intended
to be sold separately, the net quantity
of contents placement requirement of
this section applicable to such inner
containers is waived.
(g) The declaration shall accurately
reveal the quantity of cosmetic in the
package exclusive of wrappers and
other material packed therewith: Provided, That:
(1) In the case of cosmetics packed in
containers designed to deliver the cosmetic under pressure, the declaration
shall state the net quantity of the contents that will be expelled when the instructions for use as shown on the container are followed. The propellant is
included in the net quantity declaration; and
(2) In the case of a package which
contains the integral components making up a complete kit, and which is designed to deliver the components in the
manner of an application (for example,
a home permanent wave kit), the declaration may state the net quantity of
the contents in nondeceptive terms of
the number of applications available in
the kit when the instructions for use as
shown on the container are followed.
(h) The declaration shall appear in
conspicuous and easily legible boldface
print or type in distinct contrast (by
typography, layout, color, embossing,
or molding) to other matter on the
package; except that a declaration of
net quantity blown, embossed, or molded on a glass or plastic surface is permissible when all label information is

so formed on the surface. Requirements
of conspicuousness and legibility shall
include the specifications that:
(1) The ratio of height to width (of
the letter) shall not exceed a differential of 3 units to 1 unit (no more than
3 times as high as it is wide).
(2) Letter heights pertain to upper
case or capital letters. When upper and
lower case or all lower case letters are
used, it is the lower case letter ‘‘o’’ or
its equivalent that shall meet the minimum standards.
(3) When fractions are used, each
component numeral shall meet onehalf the minimum height standards.
(i) The declaration shall be in letters
and numerals in a type size established
in relationship to the area of the principal display panel of the package and
shall be uniform for all packages of
substantially the same size by complying with the following type specifications:
(1) Not less than one-sixteenth inch
in height on packages the principal display panel of which has an area of 5
square inches or less.
(2) Not less than one-eighth inch in
height on packages the principal display panel of which has an area of more
than 5 but not more than 25 square
inches.
(3) Not less than three-sixteenths
inch in height on packages the principal display panel of which has an
area of more than 25 but not more than
100 square inches.
(4) Not less than one-fourth inch in
height on packages the principal display panel of which has an area of more
than 100 square inches, except not less
than one-half inch in height if the area
is more than 400 square inches.
Where the declaration is blown, embossed, or molded on a glass or plastic
surface rather than by printing, typing, or coloring, the lettering sizes
specified in paragraphs (i)(1) through
(4) of this section shall be increased by
one-sixteenth of an inch.
(j) On packages containing less than
4 pounds or 1 gallon and labeled in
terms of weight or fluid measure:
(1) The declaration shall be expressed
both in ounces, with identification by
weight or by liquid measure and, if applicable (1 pound or 1 pint or more), followed in parentheses by a declaration

145

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00145

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

§ 701.13

21 CFR Ch. I (4–1–04 Edition)

in pounds for weight units, with any remainder in terms of ounces or common
or decimal fractions of the pound (as
set forth in paragraphs (m)(1) and (2) of
this section), or in the case of liquid
measure, in the largest whole units
(quarts, quarts and pints, or pints, as
appropriate) with any remainder in
terms of fluid ounces or common or
decimal fractions of the pint or quart
(as set forth in paragraphs (m)(3) and
(4) of this section). Net weight or fluid
measure of less than 1 ounce shall be
expressed in common or decimal fractions of the respective ounce and not in
drams.
(2) The declaration may appear in
more than one line. The term ‘‘net
weight’’ shall be used when stating the
net quantity of contents in terms of
weight. Use of the terms ‘‘net’’ or ‘‘net
contents’’ in terms of fluid measure or
numerical count is optional. It is sufficient to distinguish avoirdupois ounce
from fluid ounce through association of
terms; for example, ‘‘Net wt. 6 oz.’’ or
‘‘6 oz. net wt.’’ and ‘‘Net contents 6 fl.
oz.’’ or ‘‘6 fl. oz.’’
(k) On packages containing 4 pounds
or 1 gallon or more and labeled in
terms of weight or fluid measure, the
declaration shall be expressed in
pounds for weight units with any remainder in terms of ounces or common
or decimal fractions of the pound; in
the case of fluid measure, it shall be
expressed in the largest whole unit
(gallons, followed by common or decimal fractions of a gallon or by the
next smaller whole unit or units
(quarts or quarts and pints)) with any
remainder in terms of fluid ounces or
common or decimal fractions of the
pint or quart (as set forth in paragraph
(m)(5) of this section).
(l) [Reserved]
(m) Examples: (1) A declaration of 11⁄2
pounds weight shall be expressed as
‘‘Net wt. 24 oz. (1 lb. 8 oz.)’’, ‘‘Net wt. 24
oz. (11⁄2 lb.)’’, or ‘‘Net wt. 24 oz. (1.5
lb.)’’.
(2) A declaration of three-fourths
pound avoirdupois weight shall be expressed as ‘‘Net wt. 12 oz.’’
(3) A declaration of 1 quart liquid
measure shall be expressed as ‘‘Net
contents 32 fl. oz. (1 qt.)’’.
(4) A declaration of 13⁄4 quarts liquid
measure shall be expressed as ‘‘Net

contents 56 fl. oz. (1 qt. 11⁄2 pt.)’’ or
‘‘Net contents 56 fl. oz. (1 qt. 1 pt. 8
oz.)’’ but not in terms of quart and
ounce such as ‘‘Net content 56 fl. oz. (1
qt. 24 oz.)’’.
(5) A declaration of 21⁄2 gallons liquid
measure shall be expressed in the alternative as ‘‘Net contents 2 gal. 2 qt.’’
and not as ‘‘2 gal. 4 pt.’’
(n) For quantities, the following abbreviations and none other may be employed (periods and plural forms are
optional):
weight wt.
square sq.
fluid fl.
yard yd.
feet or foot ft.

inch in.
gallon gal.
quart qt.
pint pt.
ounce oz.
pound lb.

(o) On packages labeled in terms of
linear measure, the declaration shall
be expressed both in terms of inches
and, if applicable (1 foot or more), the
largest whole units (yards, yards and
feet, feet). The declaration in terms of
the largest whole units shall be in parentheses following the declaration in
terms of inches and any remainder
shall be in terms of inches or common
or decimal fractions of the foot or
yard. Examples are ‘‘86 inches (2 yd. 1
ft. 2 inches)’’, ‘‘90 inches (21⁄2 yd.)’’, ‘‘30
inches (2.5 ft.)’’, etc.
(p) On packages labeled in terms of
area measure, the declaration shall be
expressed in terms of square inches
and, if applicable (1 square foot or
more), the largest whole square unit
(square yards, square yards and square
feet, square feet). The declaration in
terms of the largest whole units shall
be in parentheses following the declaration in terms of square inches and
any remainder shall be in terms of
square inches or common or decimal
fractions of the square foot or square
yard; for example, ‘‘158 sq. inches (1 sq.
ft. 14 sq. inches)’’, etc.
(q) Nothing in this section shall prohibit supplemental statements at locations other than the principal display
panel(s) describing in nondeceptive
terms the net quantity of contents,
provided that such supplemental statements of net quantity of contents shall
not include any term qualifying a unit
of weight, measure, or count that tends

146

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00146

Fmt 8010

Sfmt 8010

Y:\SGML\203070T.XXX

203070T

Food and Drug Administration, HHS

§ 701.30

to exaggerate the amount of the cosmetic contained in the package; for example, ‘‘giant pint’’ and ‘‘full quart.’’
Dual or combination declarations of
net quantity of contents as provided
for in paragraphs (a), (c), and (j) of this
section (for example, a combination of
net weight plus numerical count) are
not regarded as supplemental net quantity statements and shall be located on
the principal display panel.
(r) A separate statement of the net
quantity of contents in terms of the
metric system is not regarded as a supplemental statement and an accurate
statement of the net quantity of contents in terms of the metric system of
weight or measure may also appear on
the principal display panel or on other
panels.
(s) The declaration of net quantity of
contents shall express an accurate
statement of the quantity of contents
of the package. Reasonable variations
caused by loss or gain of moisture during the course of good distribution
practice or by unavoidable deviations
in good manufacturing practice will be
recognized. Variations from stated
quantity of contents shall not be unreasonably large.

metic Act specifically excludes soap.
The term soap is nowhere defined in
the act. In administering the act, the
Food and Drug Administration interprets the term ‘‘soap’’ to apply only to
articles that meet the following conditions:
(1) The bulk of the nonvolatile matter in the product consists of an alkali
salt of fatty acids and the detergent
properties of the article are due to the
alkali-fatty acid compounds; and
(2) The product is labeled, sold, and
represented only as soap.
(b) Products intended for cleansing
the human body and which are not
‘‘soap’’ as set out in paragraph (a) of
this section are ‘‘cosmetics,’’ and accordingly they are subject to the requirements of the act and the regulations thereunder. For example, such a
product in bar form is subject to the
requirement, among others, that it
shall bear a label containing an accurate statement of the weight of the bar
in avoirdupois pounds and ounces, this
statement to be prominently and conspicuously displayed so as to be likely
to be read under the customary conditions of purchase and use.

Subpart C—Labeling of Specific
Ingredients

§ 701.30 Ingredient names established
for cosmetic ingredient labeling.

§ 701.20 Detergent substances, other
than soap, intended for use in
cleansing the body.
(a) In its definition of the term cosmetic, the Federal Food, Drug, and Cos-

The Commissioner establishes the
following names for the purpose of cosmetic ingredient labeling pursuant to
paragraph (e) of § 701.3:

Chemical name or description

Chemical formula

Trichlorofluoromethane ..............................................................
Trichlorofluoromethane and 0.3 pct nitromethane ....................
Dichlorodifluoromethane ............................................................
Chlorodifluoromethane ...............................................................
1, 2-dichloro-1, 1, 2, 2-tetrafluoroethane ...................................
1-Chloro-1, 1-difluoroethane ......................................................
1, 1-difluoroethane .....................................................................
Ethyl ester of hydrolyzed animal protein is the ester of ethyl
alcohol and the hydrolysate of collagen or other animal protein, derived by acid, enzyme, or other form of hydrolysis.

CCl3F ..................
CCl3F+CH3NO2 ..
CCl2F2 ................
CHClF2 ...............
CClF2CClF2 ........
CH3CClF2 ...........
CH3CHF2 ............
.............................

Established label name
Chlorofluorocarbon 11.
Chlorofluorocarbon 11 S.
Chlorofluorocarbon 12.
Hydrochlorofluorocarbon 22.
Chlorofluorocarbon 114.
Hydrochlorofluorocarbon 142 B.
Hydrofluorocarbon 152 A.
Ethyl ester of hydrolyzed animal protein.

[42 FR 24255, May 13, 1977, as amended at 45 FR 3577, Jan. 18, 1980]

147

VerDate mar<24>2004

15:40 Jul 07, 2004

Jkt 203070

PO 00000

Frm 00147

Fmt 8010

Sfmt 8016

Y:\SGML\203070T.XXX

203070T