Pretest

Paperwork Reduction Act Statement

OMB Control No. 0910-xxxx

Expiration Date: xx/xx/xxxx

Paperwork Reduction Act Statement: According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a valid OMB control number. The valid OMB control number for this information collection is 0910-XXXX. The time required to complete this portion of the information collection is estimated to average 20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to [email protected].

Base: All respondents

DISPLAY1 [DISP]

This study is funded by the U.S. Food and Drug Administration (FDA) and conducted by researchers from RTI International. This survey asks questions about your use and experience with cosmetic products. By cosmetic products, we mean products used on your face, skin, hair, nails, or other parts of the body for the purposes of cleansing or improving appearance. These products include lotion, makeup, shampoo, toothpaste (without fluoride), shaving products, perfume, and similar products. Such products can be purchased for home use or delivered as part of services at a spa or salon.

In addition, this survey asks questions about whether you have had an allergic reaction after using a cosmetic product. A person has an allergy when their immune system overreacts to encountering certain substances called allergens. This overreaction can create unwanted reactions like itchiness or blistering, among others.

Your participation in this study is completely voluntary, and you may skip any questions you do not want to answer. All your answers will be kept secure to the extent provided by law. In our experience, answering the survey questions involves no more risk of harm than you would experience in everyday life.

If you have any questions about the study, you may contact Dallas Wood of RTI at 1‑800‑334‑8571, extension 27206 or by email at [email protected]. If you have any questions about your rights as a study participant, you may contact RTI’s Office of Research Protection at 1-866-214-2043 or by email at [email protected]. 

Study Information

Client: FDA/RTI

Project Title: Cosmetics Survey

Project WBS: 310.209.01551.1

Account Executive: Michael Lawrence

Project Manager: Ying Wang ([email protected])

Research Associate:

Sample Variables

• KP standard demographics

Quota Description

No quotas

Standard Question Type Descriptions

Standard question types include:

• S = Single Select: Allows respondents to select one answer from a list of options.

• M = Multi-select: Allows respondents to select multiple answers from a list of options.

• DD = Dropdown Menu: Allows respondents to select one answer from a drop-down menu of options.

• Grid (including options for banked or accordion grids)

• S (Optional: Banked/Accordion) Grid: Allows respondents to select one answer in a 2-dimensional grid layout.

• M (Optional: Banked/Accordion) Grid: Allows respondents to select multiple answers in a 2-dimensional grid layout.

• N = Number: Allows respondents to enter a numeric response in an open-ended answer field (specify valid range or number of digits, e.g., up to three digits for age, five numbers for zip code)

• T = Text: Allows respondents to enter a text response in an open-ended answer field (specify size as Small, Medium, Large or a specific number of characters, e.g., two letters for U.S. state)

• DISP = Display/Descriptive Content: Displays text and/or multimedia elements to respondents without requiring interaction.

• RT = Ratings Thermometer: Allows respondents to select a numeric value (usually 0−100 on a visual scale resembling a thermometer

• RS = Ratings Slider: Allows respondents to select a numeric value (usually 0−100 on a horizontal visual scale with the endpoints labelled).

Main Questionnaire (including screener, if applicable)

Programming Notes:

• Code all refusals as -1.

• Use default instruction text for each question type unless otherwise specified.

• Do not prompt on all questions. (Remove this instruction if sample is all opt-in, client list sample, or otherwise not KP.)

Base: All respondents

DISPLAY2 [DISP]

This first set of questions asks about the cosmetic products you use and how often you use them.

Show above display & 1^st screen of Q1 on the same screen.

Base: All respondents

Q1 [S, Accordion]

How often do you use each of the following products?

Statements in row:

Scripters: Options shown in bold are category names – Please do not display that in the link

We have 11 categories for this question; products under each category should be shown on a separate screen, so there should be 11 screens for this question

Prompt once if refused

Please change instructions from “Select one answer from each row” to “Select one answer for each product”

a. Baby products

1. Baby shampoos, conditioners, or cleansers

2. Baby skin care products, like oils or lotions

3. Baby wipes

b. Bath additives

4. Bath additives, like bombs, bubbles, foams, oils, or salts

c. Fragrance preparations

5. Body spray or mist

6. Cologne, perfume, and toilet water

7. Fragrance powder

d. Hair preparations

8. Shampoos and conditioners

9. Hair styling products, like gel, mousse, pomade, spray, wax, including beard and moustache care products

10. Permanent waves, relaxers, and straighteners

11. Hair coloring

12. Artificial hair, adhesives, and solvents (wig, mustache, beard, etc.)

13. Hair loss concealers, excluding hair growth drugs such as Rogaine®

e. Hair removal and shaving products

14. Shaving and preshaving products like creams, gels, lotions, oils, or soaps

15. Aftershave products, like balms, creams, gels, lotions, or oils

16. Hair removal wax or depilatories

17. Shaving blades with lubricant

f. Make up preparations

18. Face color makeup, not including face paints

19. Eye color makeup, like eyeshadow, eyeliner, mascara, eyebrow pencils or gels.

20. Lip color makeup

21. Artificial eyelashes, adhesives, and artificial eyelash removers

22. Leg and body paints

23. Novelty makeups and accessories, like decals, face paint, stick-on jewelry, stickers, etc.

g. Nail polishes and coats

24. Nail polishes and coats, nail polish removers, nail care products, and nail cleansers

25. Artificial nails, adhesives, and artificial nail removers

26. Novelty nail accessories, like decals, stick-on jewelry, or stickers

h. Oral hygiene products

27. Dental cleansers, like toothpaste without fluoride

28. Mouthwashes and breath fresheners, like liquids, sprays, or strips

29. Tooth whiteners, like gels or strips

i. Personal cleanliness

30. Body and hand cleansing products

31. Facial cleansing products, including makeup removers and wipes

32. Deodorants (underarm)

33. Feminine hygiene products, like creams, deodorants, douches, lotions, powders, or sprays. Do not include pads or tampons.

j. Skin care preparations

34. Body, foot, and hand care products, like creams, lotions, oils, or powders

35. Face care products, like creams, lotions, or serums

36. Eye area care products, like creams, lotions, or serums

37. Lip area care products, like balms

38. Exfoliants, masks, and scrubs

39. Massage products, like lotions or oils

k. Suntan preparations

40. Self and sunless tanning products

41. Suntan products, like creams, gels, liquids, lotions, oils, or sprays, not including sunscreen

Answers in column:

1. Never

2. Less than once or twice a year

3. Every 2 or 3 months

4. Monthly

5. Weekly

6. A few times per week

7. Once a day

8. More than once a day

Base: If Q1_30=2-8

Q1a [S]

How sure are you that the dental cleansers (i.e., toothpaste) you use [INSERT RESPONSE] do not contain fluoride?

1. Not at all sure

2. Not sure

3. Somewhat sure

4. Sure

5. Very sure

Base: All respondents

DISPLAY3 [DISP]

The next set of questions asks about factors you consider when buying cosmetic products and where you buy them.

Show above display & 1^st question on the order on the same screen.

Randomize the order of Q2-Q7 and record the order.

Base: All respondents

Q2 [S]

How often do you buy cosmetic products labeled as “Hypoallergenic”?

1. Always

2. Most of the time

3. Sometimes

4. Rarely

5. Never

Base: All respondents

Q3 [S]

How often do you buy cosmetic products labeled as “For Sensitive Skin”?

1. Always

2. Most of the time

3. Sometimes

4. Rarely

5. Never

Base: All respondents

Q4 [S]

How often do you buy cosmetic products labeled as “Natural”?

1. Always

2. Most of the time

3. Sometimes

4. Rarely

5. Never

Base: All respondents

Q5 [S]

How often do you buy cosmetic products labeled as “Organic”?

1. Always

2. Most of the time

3. Sometimes

4. Rarely

5. Never

Base: All respondents

Q6 [S]

How often do you buy cosmetic products labeled as “Paraben-free”?

1. Always

2. Most of the time

3. Sometimes

4. Rarely

5. Never

Base: All respondents

Q7 [S]

How often do you buy cosmetic products labeled as “Gluten-free”?

1. Always

2. Most of the time

3. Sometimes

4. Rarely

5. Never

Base: All respondents

Q7 [S]

How often do you buy cosmetic products labeled as “Fragrance-free”?

1. Always

2. Most of the time

3. Sometimes

4. Rarely

5. Never

Base: All respondents

Q8 [S]

How often do you look for an expiration date before buying a cosmetic product?

1. Always

2. Most of the time

3. Sometimes

4. Rarely

5. Never

Base: All respondents

Q9 [S]

If a cosmetic product is past its expiration date, do you typically keep using it or throw it away?

1. I keep using it.

2. I throw it away.

3. I never read the expiration date on cosmetic products.

Base: If Q9=1

Q10 [S]

How long do you keep using the cosmetic product after it has passed its expiration date?

1. 1 to 2 days

2. 3 to 6 days

3. 1 to 2 weeks

4. I use it until the product is gone.

Base: if any Q1=2-8

Q11 [S, Accordion]

Where do you usually buy the following cosmetic products?

If you buy products from an online retailer that also has a physical store, select “Online Retailer.” For example, if you buy from Walmart.com or Target.com, select “Online Retailer.”

Scripters: Options shown in bold are category names – Please do not display that in the link

We have 11 categories for this question; products under each category should be shown on a separate screen, so there should be 11 screens for this question

Display only products with response options selection 2-8 in Q1

Change instructions on screen from “Select one answer from each row” to “Select one answer for each product”

Statements in row:

a. Baby products

1. Baby shampoos, conditioners, or cleansers

2. Baby skin care products, like oils or lotions

3. Baby wipes

b. Bath additives

4. Bath additives, like bombs, bubbles, foams, oils, or salts

c. Fragrance preparations

5. Body spray or mist

6. Cologne, perfume, and toilet water

7. Fragrance powder

d. Hair preparations

8. Shampoos and conditioners

9. Hair styling products, like gel, mousse, pomade, spray, wax, including beard and moustache care products

10. Permanent waves, relaxers, and straighteners

11. Hair coloring

12. Artificial hair, adhesives, and solvents (wig, mustache, beard, etc.)

13. Hair loss concealers, excluding hair growth drugs such as Rogaine®

e. Hair removal and shaving products

14. Shaving and preshaving products like creams, gels, lotions, oils, or soaps

15. Aftershave products, like balms, creams, gels, lotions, or oils

16. Hair removal wax or depilatories

17. Shaving blades with lubricant

f. Make up preparations

18. Face color makeup, not including face paints

19. Eye color makeup, like eyeshadow, eyeliner, mascara, eyebrow pencils or gels.

20. Lip color makeup

21. Artificial eyelashes, adhesives, and artificial eyelash removers

22. Leg and body paints

23. Novelty makeups and accessories, like decals, face paint, stick-on jewelry, stickers, etc.

g. Nail polishes and coats

24. Nail polishes and coats, nail polish removers, nail care products, and nail cleansers

25. Artificial nails, adhesives, and artificial nail removers

26. Novelty nail accessories, like decals, stick-on jewelry, or stickers

h. Oral hygiene products

27. Dental cleansers, like toothpaste without fluoride

28. Mouthwashes and breath fresheners, like liquids, sprays, or strips

29. Tooth whiteners, like gels or strips

i. Personal cleanliness

30. Body and hand cleansing products

31. Facial cleansing products, including makeup removers and wipes

32. Deodorants (underarm)

33. Feminine hygiene products, like creams, deodorants, douches, lotions, powders, or sprays. Do not include pads or tampons.

j. Skin care preparations

34. Body, foot, and hand care products, like creams, lotions, oils, or powders

35. Face care products, like creams, lotions, or serums

36. Eye area care products, like creams, lotions, or serums

37. Lip area care products, like balms

38. Exfoliants, masks, and scrubs

39. Massage products, like lotions or oils

k. Suntan preparations

40. Self and sunless tanning products

41. Suntan products, like creams, gels, liquids, lotions, oils, or sprays, not including sunscreen

Answers in column:

1. Physical Store

2. Online Retailer

3. Salon or Spa

Base: All respondents

DISPLAY4 [DISP]

These next questions ask about reactions you may have experienced after using a cosmetic product.

Show above display & Q12 on the same screen.

Base: All respondents

Prompt once if refused

Q12 [S]

Do you have an allergy to certain cosmetic products?

1. Yes

2. No

3. I don’t know

Base: If Q12=1

Q13 [S]

How long have you had any allergy to cosmetic products?

1. Less than 6 months

2. 1 year

3. 2 to 4 years

4. 5 to 10 years

5. More than 10 years

Base: If Q12=1

Prompt once if refused

Q23 [S]

Did a doctor or health care professional do a test to check if you have a skin allergy?

1. Yes

2. No

Base: If Q23=1

Prompt once if refused

Q24 [M]

What kind of test did the doctor do?

1. Blood test

2. Prick test

3. Intradermal or injection test

4. Patch test

5. Can’t recall [s]

6. None of the above [s]

Base: If Q23=1

Prompt once if refused

Q25 [S]

Did the doctor confirm you have a skin allergy?

1. Yes

2. No

Base: If Q25=1

Prompt once if refused

Q26 [M]

Which allergen(s) are you allergic to?

1. 2-Bromo-2-nitropropane-1,3-diol (Bronopol)

2. Acrylates
3. Amerchol L101
4. Balsam of Peru
5. Benzophenone 3
6. Cetyl/stearyl alcohol
7. Cobalt
8. Cocamidopropyl betaine
9. Diazolidinyl urea
10. Dimethylol dimethyl hydantoin (DMDH)
11. Fragrance mix ingredients
12. Gold
13. Imidazolidinyl urea
14. Iodopropynyl butylcarbamate
15. Methyldibromo-glutaronitrile
16. Methylisothiazolinone (MIT)
17. Nickel
18. Parabens mix
19. Phenoxyethanol
20. p-Phenylenediamine
21. Propylene glycol
22. Quaternium-15
23. Tea tree oil
24. Tosylamide/formaldehyde resin
25. Wool alcohol
26. Other (Please specify) [LARGE TEXT BOX]

Base: If Q26=11

Q27 [M]

Which fragrance mix allergen(s) are you allergic to?

1. Amylcinnamyl alcohol
2. Anisyl alcohol
3. Banzyl salicylate
4. Benzyl alcohol
5. Benzyl benzoate
6. Benzyl cinnamate

7. Cinnamal
8. Cinnamaldehyde (cinnamal, cinnamic aldehyde)
9. Cinnamyl alcohol (cinnamic alcohol)
10. Citral
11. Citronellol
12. Coumarin
13. d-Limonene
14. Eugenol
15. Farnesol
16. Geraniol
17. Hexyl cinnamaladehyde
18. Hydroxycitronellal
19. Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC), Lyral
20. Isoeugenol
21. Lilial
22. Linalool
23. Methyl 2-octynoate
24. Oak moss extract, or Evernia prunastri extract
25. Tree moss extract, or Evernia furfuracea extract
26. α-Methylionone
27. Other (Please specify) [LARGE TEXT BOX]

Base: any Q1=2-8

Q14 [M, Accordion]

Have you ever unexpectedly had any of the following reactions after using any of the following cosmetic products?

Scripters: Options shown in bold are category names – Please do not display that in the link

We have 11 categories for this question; products under each category should be shown on a separate screen, so there should be 11 screens for this question

Display only products with response options selection 2-8 in Q1

Prompt once if refused

Statements in row:

a. Baby products

1. Baby shampoos, conditioners, or cleansers

2. Baby skin care products, like oils or lotions

3. Baby wipes

b. Bath additives

4. Bath additives, like bombs, bubbles, foams, oils, or salts

c. Fragrance preparations

5. Body spray or mist

6. Cologne, perfume, and toilet water

7. Fragrance powder

d. Hair preparations

8. Shampoos and conditioners

9. Hair styling products, like gel, mousse, pomade, spray, wax, including beard and moustache care products

10. Permanent waves, relaxers, and straighteners

11. Hair coloring

12. Artificial hair, adhesives, and solvents (wig, mustache, beard, etc.)

13. Hair loss concealers, excluding hair growth drugs such as Rogaine®

e. Hair removal and shaving products

14. Shaving and preshaving products like creams, gels, lotions, oils, or soaps

15. Aftershave products, like balms, creams, gels, lotions, or oils

16. Hair removal wax or depilatories

17. Shaving blades with lubricant

f. Make up preparations

18. Face color makeup, not including face paints

19. Eye color makeup, like eyeshadow, eyeliner, mascara, eyebrow pencils or gels.

20. Lip color makeup

21. Artificial eyelashes, adhesives, and artificial eyelash removers

22. Leg and body paints

23. Novelty makeups and accessories, like decals, face paint, stick-on jewelry, stickers, etc..

g. Nail polishes and coats

24. Nail polishes and coats, nail polish removers, nail care products, and nail cleansers

25. Artificial nails, adhesives, and artificial nail removers

26. Novelty nail accessories, like decals, stick-on jewelry, or stickers

h. Oral hygiene products

27. Dental cleansers, like toothpaste without fluoride

28. Mouthwashes and breath fresheners, like liquids, sprays, or strips

29. Tooth whiteners, like gels or strips

i. Personal cleanliness

30. Body and hand cleansing products

31. Facial cleansing products, including makeup removers and wipes

32. Deodorants (underarm)

33. Feminine hygiene products, like creams, deodorants, douches, lotions, powders, or sprays. Do not include pads or tampons.

j. Skin care preparations

34. Body, foot, and hand care products, like creams, lotions, oils, or powders

35. Face care products, like creams, lotions, or serums

36. Eye area care products, like creams, lotions, or serums

37. Lip area care products, like balms

38. Exfoliants, masks, and scrubs

39. Massage products, like lotions or oils

k. Suntan preparations

40. Self and sunless tanning products

41. Suntan products, like creams, gels, liquids, lotions, oils, or sprays, not including sunscreen

Answers in column:

1. None

2. Burning of the skin or eyes

3. Watery eyes

4. Blistering skin

5. Hair Loss

6. Itchy skin or eyes

7. Scabs or Scales on skin

8. Skin Rash or Redness

9. Swelling of skin or eyes

10. Other (Specify) [Text box]

Base: Q14 =2-9 selected for at least two items

Q15 [S]

You indicated that you have experienced a reaction from using more than one type of cosmetic product. What type of product caused your most recent reaction?

Display only products with response options selection 2-9 in Q14

1. Baby shampoos, conditioners, or cleansers

2. Baby skin care products, like oils or lotions

3. Baby wipes

4. Bath additives, like bombs, bubbles, foams, oils, or salts

5. Body spray or mist

6. Cologne, perfume, and toilet water

7. Fragrance powder
8. Shampoos and conditioners

9. Hair styling products, like gel, mousse, pomade, spray, wax, including beard and moustache care products

10. Permanent waves, relaxers, and straighteners

11. Hair coloring

12. Artificial hair, adhesives, and solvents (wig, mustache, beard, etc.)

13. Hair loss concealers, excluding hair growth drugs such as Rogaine®

14. Shaving and preshaving products, like creams, gels, lotions, oils, or soaps

15. Aftershave products, like balms, creams, gels, lotions, or oils
16. Hair removal wax or depilatories

17. Shaving blades with lubricant

18. Face color makeup, not including face paints

19. Eye color makeup, like eyeshadow, eyeliner, mascara, eyebrow pencils or gels.

20. Lip color makeup

21. Artificial eyelashes, adhesives, and artificial eyelash removers

22. Leg and body paints

23. Novelty makeups and accessories, like decals, face paint, stick-on jewelry, stickers, etc.

24. Nail polishes and coats, nail polish removers, nail care products, nail cleansers

25. Artificial nails, adhesives, and removers
29. Novelty nail accessories, like decals, stick-on jewelry, or stickers

30. Dental cleansers, like toothpaste without fluoride
31. Mouthwashes and breath fresheners (liquid, spray, strip, etc.)

32. Tooth whiteners (gel, strip, etc.)

33. Body and hand cleansing products

34. Facial cleansing products, including makeup removers and wipes

35. Deodorants (underarm)

36. Feminine hygiene products, like creams, deodorants, douches, lotions, powders, or sprays. Do not include pads or tampons.
37. Body, foot, and hand care products, like creams, lotions, oils, or powders
38. Face care products, like creams, lotions, or serums
39. Eye area care products, like creams, lotions, or serums
40. Lip area care products, like balms
41. Exfoliants, masks, and scrubs
42. Massage products, like lotions or oils
43. Self and sunless tanning products
44. Suntan products, like creams, gels, liquids, lotions, oils, or sprays, not including sunscreen

Base: if any Q14=2-9

Q16a [S]

Think about your most recent reaction to using [INSERT RESPONSE]. How long ago did you have this reaction?

If Q14=2-9 for only one row item, insert row item

If Q14=2-9 for more than one row item, insert Q15 response

If Q14=2-9 for more than one row item and Q15 =refused, randomly select one item from Q14=2-9

Change to lower case for the 1^st word

1. Within the past 2 years

2. 3 or 4 years ago

3. 5 years ago

4. 6 to 9 years ago

5. 10 or more years ago

Base: if any Q14=2-9

Q16b [S]

Think about your reaction to using [INSERT Q15]. How long after you started using the product did you notice the reaction?

1. Less than 1 day

2. 1 day

3. 2 to 4 days

4. 5 to 7 days

5. More than 7 days

Base: if any Q14=2-9

Q17 [S]

How long did this reaction last?

1. Less than 1 day

2. 1 day

3. 2 to 4 days

4. 5 to 7 days

5. 8 to 14 days

6. More than 14 days

Base: if any Q14=2-9

Q18 [Grid]

Did the reaction create any problems for you in the following areas?

Statements in row:

a. Mobility (e.g. ability to walk around)

b. Self-Care (e.g. ability to wash and dress yourself)

c. Ability to conduct usual activities (e.g. work, study, housework, family or leisure activities)

d. Pain or discomfort

e. Anxiety or depression

Answers in column:

1. No problems

2. Moderate problems

3. Severe problems

Base: if any Q14=2-9

Q19 [S]

When you had this reaction, did you report it to the Food and Drug Administration (FDA)?

1. Yes

2. No

3. Can’t recall

Base: If Q19=1

Q20 [M]

How did you report this reaction to FDA?

1. Called

2. Sent an e-mail

3. Filled out online form
4. Filled out paper form and mailed it

Base: if any Q14=2-9

Q21 [S]

Did you report this reaction to the product’s manufacturer?

1. Yes

2. No

3. Can’t recall

Base: if any Q14=2-9

Prompt once if refused

Q22 [S]

When you had this reaction, did you see a doctor or another health care provider?

1. Yes

2. No

Base: All respondents

Q28 [S]

Do you actively try to avoid using any cosmetic products because they may cause some kind of reaction?

1. Yes, all of the time
2. Yes, some of the time
3. No

Base: If Q28=1 or 2

Q29 [M]

How do you decide which cosmetic products to avoid?

1. Read ingredient lists
2. Read other information on product labels
3. Read product reviews
4. Read product advertisements
5. Ask my doctor
6. Ask my friends and/or family
7. Rely on past experience
8. Other (Please specify) [LARGE TEXT BOX]

Base: All respondents

[DISPLAY 5]

Thank you. These are all the questions in this survey. We hope you have enjoyed your participation in the survey.

Show KP closing question QF1