Cosmetic registration and listing

COSMETICS DIRECT
Electronic Submissions Portal

TABLE OF CONTENTS
 FDA Direct Home Page…………………………………………...

3

 Create New Account………………………………………………

4

 Terms of Service…………………………………………………..

5

 Home Page Welcome Pop-Up…………………………………….. 6
 Registration of Cosmetic Product Facility…………………….…. 8
 Create a New Registration or Upload An Existing File………... 10
 Registration Status Examples………………………………….. 32
 Cosmetic Product Listing…………………………………........... 43
 Create A New Product Listing or Upload An Existing File….... 45
 Product Listing Status Examples………………………….…... 71
 Cosmetics Direct home page…………………………………….. 82
 Details…………………………………………………………. 83
 All Submission ………………………………………............... 84

FDA DIRECT HOME PAGE
The WELCOME TO FDA DIRECT provides short background info about each (CDER Direct and
Cosmetics Direct). First time user can create a new account by selecting the Create New Account.

WARNING: This warning banner provides privacy and security notices consistent with applicable federal laws, directives, and other federal guidance for
accessing this Government system, which includes all devices/storage media attached to this system. This system is provided for Government authorized use
only. Unauthorized or improper use of this system is prohibited and may result in disciplinary action and/or civil and criminal penalties. At any time, and for
any lawful Government purpose, the Government may monitor, record, and audit your system usage and/or intercept, search and seize any communication or
data transiting or stored on this system. Therefore, you have no reasonable expectation of privacy. Any communication or data transiting or stored on this
system may be disclosed or used for any lawful Government purpose.

CREATE A NEW ACCOUNT

There are three types of account that can be created: CDER Direct, COSMETICS Direct, and Both (CDER Direct &
COSMETICS Direct). DUNS is only a required field if you create a CDER Direct account or Both (CDER Direct and
Cosmetics Direct) account. DUNS is NOT required if you create only a COSMETICS Direct account. The system will
streamline submissions to save time for the user who has drugs as well as cosmetics to choose both (CDER Direct &
COSMETICS Direct) under one functional account.

TERMS OF SERVICE

Before logging into the account, the user will have to agree to the terms of service, by selecting I
AGREE that will pop-up once selecting, I accept the terms of service

HOME PAGE WELCOME POP-UP
A burden statement and standard PRA information will appear in the welcome pop-up each
time a user logs in. (information is a place holder subject to change)

COSMETICS DIRECT HOME PAGE
Home page of the Cosmetics Direct after creating an account within FDA Direct
SUBMISSIONS:
Two types of selections
are shown here:
Registration of Cosmetic
Product Facility and
Cosmetic Product Listing.
Depending on the account
created, account holder
may have additional form
selections.

SELF-HELP:
Articles and weblinks
are provided for
additional
information. This box
will be available
throughout the
submission process.

MANAGE ACCOUNT:
Manage sub-users of the account
and update profile information.

The ability to view all the previous
product listing submissions based
on user’s access.

REGISTRATION OF COSMETIC
PRODUCT FACILITY
Registration of Cosmetic Product Facility Home Page………..….…….9
Create a New Registration or Upload An Existing File………….….....10
Registration Status Examples………………………………………….32

HOME PAGE: REGISTRATION OF COSMETIC
PRODUCT FACILITY
SUBMISSIONS:
Two types of selections
are shown here:
Registration of Cosmetic
Product Facility and
Cosmetic Product Listing.
Depending on the account
created, account holder
may have additional form
selections.
SELF-HELP:
Articles and weblinks are
provided for additional
information. This box
will be available
throughout the
submission process.

MANAGE ACCOUNT:
Manage sub-users of the account
and update profile information.

The ability to view all the previous
product listing submissions based
on user’s access.

CREATE
NEW/UPLOAD
FILE

CREATE A NEW REGISTRATION
OR UPLOAD AN EXISTING FILE

CREATE A NEW REGISTRATION OR UPLOAD AN EXISTING FILE
Selecting the CREATE NEW/UPLOAD FILE box, from the Registration of Cosmetic Product Facility home page will direct
user to this page with an option of creating an initial Cosmetic Product Facility Registration using a blank form or importing an FDAaccepted SPL stored on your computer in a valid XML zip file. SPL (Structured Product Labeling) is a document markup standard
approved by Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information.
Importing an existing Cosmetic Product facility registration SPL will be beneficial for bulk submission

CREATE A NEW PRODUCT FACILITY REGISTRATION
Create an Initial Cosmetic Product Facility Registration using a blank form.

DOCUMENT TYPE DETAILS
Set ID and Root ID are auto-generated, and the Effective Dates is the date the submission is created, but users can modify it.
Once an SPL has been submitted, this date cannot be edited by users.

A Guide that
will help the
user
understand
different
stages such as,
SAVE AS
DRAFT.

DOCUMENT TYPE TOOL TIPS
A *RED* asterisk indicates field is mandatory.
A dashed underline indicates help text (tool-tips) if clicked on.

DOCUMENT TYPE DETAILS

By selecting the drop-down ( ), Five document type options will appear; initial, amended-changes to
registration, amended-cancellation of registration, biennial registration renewal, and abbreviated
registration renewal. (First time users will only have INITIAL as an option)

DOCUMENT TYPE DETAILS

Depending on which document type is selected, an ALERT box will appear, “By selecting this
document type, you are certifying that no changes have been made to your registration since the
previous registration was submitted”

REGISTRATION DETAILS
A *RED* asterisk indicates field is mandatory. A dashed underline indicates help text
(tool-tips) if clicked on, as listed on the left side. A link is also provided in the tool-tip for
more information regarding the registration and listing of cosmetic product facilities and
products.

HOME

REGISTRATION
DETAILS
By selecting a different country,
the U.S. AGENT CONTACT
INFORMATION will be needed.

A dashed underline indicates
help text (tool-tips) if clicked
on, as listed below.

HOME

BRAND
NAME(S)

Add Brand Names of
cosmetic products
manufactured or
processed at this
facility by selecting
ADD BRAND
NAMES

HOME

BRAND NAME(S) OF COSMETIC PRODUCT(S)
MANUFACTURED OR PROCESSED IN THIS FACILITY
Multiple Brand Names
can be submitted by
selecting SAVE AND
ADD MORE BRAND

Select all the
Category code(s) that
applies to this Brand
Name

HOME

BRAND NAME(S) OF COSMETIC PRODUCT(S) MANUFACTURED OR
PROCESSED IN THIS FACILITY(EXAMPLE)
A dashed underline
indicates help text
(tool-tips) if clicked
on, as listed below.

By selecting the (+) of the MAIN PRODUCT
CATEGORY, a SUB PRODUCT CATEGORY will
appear & if that sub product category had a SUB-SUB
PRODUCT CATEGORY, (+) can be selected.

BRAND NAME OF
COSMETIC
PRODUCT
MANUFACTURED
OR PROCESSED IN
THIS FACILITY
(EXAMPLE)

The information that was
provided in the BRAND
NAME TAB will appear
under BRAND NAMES.

CONFIRMATION
STATEMENT
A dashed underline indicates help
text (tool-tips) if clicked on, as
listed below.

After understanding the confirmation
statement. Select AGREE

ADDITIONAL CONTACT INFORMATION FOR
AUTHORIZED AGENT
A dashed underline indicates help text (tool-tips) if clicked on, as listed below.

COMPLETED
After filling in all the required information, SAVE AND VALIDATE, to identify any errors.
OR
Select submit SPL for the form to be submitted to FDA.

A Guide that will help the
user understand different
stages such as,
VAILADATE SPL or
SUBMIT SPL.

UPLOAD A FILE

In order to upload a file, select Import an existing Cosmetic Product Facility Registration SPL.
Importing an existing Cosmetic Product Facility Registration SPL will be beneficial for bulk
submission.

UPLOAD A FILE

User will be able to upload a pre-existing ZIP FILE. This file may contain both the xml file and
image (jpg) files. For more information regarding SPL, utilize the Structured Product Labeling
Resources | FDA (SPL) link provided under SELF-HELP

UPLOAD A FILE (EXAMPLE)
The content in the red circle is an example to what a zip file could be, may contain .xml file
and image (jpg) files.

ZIP FILE (EXAMPLE)
An example to what an XML format could look like

UPLOAD A FILE (EXAMPLE)

After UPLOADING A FILE (XML ZIP FILE), the system will auto-fill all the required fields and the form will be ready to save and
validate to check for any errors. This is an easy way to submit multiple Cosmetic Product Facility Registrations under one submission ID.
VALIDATE SPL: “You can check your SPL for an initial validation before submitting to FDA. This option does not automatically
submit your SPL to FDA, even if it passes the initial validation, but scans for certain errors prior to the actual submission. ”
SPL(Structured Product Labeling) is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a
mechanism for exchanging product and facility information.

TOUR
GUIDE

A Guide that will help the
user understand different
submission stage such as,
VAILADATE SPL.

UPLOAD A FILE (EXAMPLE)
Select submit SPL for the form to be submitted to FDA.
The Submit SPL box is a help tool that can guide a user through the process.

REGISTRATION STATUS
EXAMPLES

REGISTRATION STATUS: VALIDATION IN PROGRESS
After SAVE AND VALIDATE, the registration of cosmetic product facility home page will have the
following details as shown below. The status will be in VALIDATION IN PROGRESS.

REGISTRATION STATUS: READY FOR SUBMISSION
VALIDATE SPL: You can check your SPL for an initial validation before submitting to FDA. This option does not
automatically submit your SPL to FDA, even if it passes the initial validation, but scans for certain errors prior to the actual
submission.
Once the system has completed a quick VALIDATION, the status VALIDATION IN PROGRESS will change to READY
FOR SUBMISSION.

REGISTRATION STATUS: READY FOR SUBMISSION to SUBMIT SPL
By clicking on the READY FOR SUBMISSION, the registration will be ready for SUBMIT SPL.
The system will generate a message stating that, This submission has passed the INITIAL VALIDATION but
has NOT been ACTUALLY SUBMITTED TO FDA. Click ON "SUBMIT SPL" to SUBMIT.

REGISTRATION STATUS: SUBMIT SPL to SUBMISSION ACCEPTED
The status will change to SUBMISSION ACCEPTED after registration process had been successfully completed. A
SUBMISSION ID will be given to all ACCEPTED SUBMISSIONS.

REGISTRATION STATUS: SUBMISSION ACCEPTED to VIEW SPL and
DOWNLOAD SPL
By clicking on the SUBMISSION ACCEPTED the system will allow the user to VIEW SPL and
DOWNLOAD SPL.

CREATE A NEW VERSION
By clicking on the CREATE A NEW VERSION, you can clone a successfully-submitted SPL as a starting
point.

REGISTRATION STATUS: VALIDATION FAILURE
After SAVE AND VALIDATE, the registration of cosmetic product facility home page will have the
following details as shown below. The status will be in VALIDATION IN PROGRESS. However, if the
system finds any errors the status will change to VALIDATION FAILURE.

REGISTRATION STATUS: VALIDATION FAILURE
After selecting the VALIDATION FAILURE status, the system will provide a list of errors, that need to be
fixed before submitting the SPL. After reviewing and fixing the errors, users can select SUBMIT SPL to
resubmit the SPL or SAVE AND VALIDATE to check for any additional errors.

REGISTRATION STATUS: DRAFT
By selecting SAVE AS DRAFT, from any screen during the process of registration of cosmetic product
facility, the system saves all information and will bring the user back to the home page. The status will be in
DRAFT.

REGISTRATION STATUS: DRAFT
The registration of cosmetic product facility home page will have the following details as shown below.
The status will be in DRAFT.

COSMETIC PRODUCT LISTING
Cosmetic Product Listing Home Page..……………………............44
Create A New Product Listing or Upload An Existing File…..........45
Product Listing Status Examples………………………….….........71

HOME PAGE: COSMETIC PRODUCT LISTING
SUBMISSIONS:
Two types of selections
are shown here:
Registration of Cosmetic
Product Facility and
Cosmetic Product Listing.
Depending on the account
created, account holder
may have additional form
selections.
SELF-HELP:
Articles and weblinks
are provided for
additional
information. This box
will be available
throughout the
submission process.

MANAGE ACCOUNT:
Manage sub-users of the account
and update profile information.

The ability to view all the previous
product listing submissions based
on user’s access.

CREATE
NEW/UPLOAD
FILE

CREATE A NEW PRODUCT
LISTING OR UPLOAD AN
EXISTING FILE

CREATE A NEW PRODUCT LISTING OR UPLOAD AN EXISTING FILE
Selecting the CREATE NEW/UPLOAD FILE box, from the Cosmetic Product listing home page will direct user to this
page with an option of creating an initial Cosmetic Product Listing using a blank form or import an FDA-accepted SPL stored
on your computer in a valid XML zip file. SPL (Structured Product Labeling) is a document markup standard approved by
Health Level Seven (HL7) and adopted by FDA as a mechanism for exchanging product and facility information. Importing an
existing Cosmetic Product Listing SPL will be beneficial for bulk submission

CREATE A NEW COSMETICS PRODUCT LISTING
Create an Initial Cosmetic Product Listing using a blank form.

DOCUMENT TYPE DETAILS

Set ID and Root ID are auto-generated, and Effective Date is the
date the submission is created, but users can modify it. Once an
SPL has been submitted, this date cannot be edited by users.

DOCUMENT TYPE TOOL TIPS
A *RED* asterisk indicates field is mandatory. Dashed underline indicates help text (tool-tips) if clicked on.

DOCUMENT TYPE DETAILS

By selecting the drop-down ( ), four document types options will appear; initial, update to content (annual)(changes to listing), update to content (annual)-(discontinuation of listing), and abbreviated renewal.

A Guide that will help the
user understand different
submission stage such as,
VAILADATE SPL, SAVE
AS DRAFT.

DOCUMENT TYPE DETAILS
Depending on which document type is selected, an ALERT box will appear, “By selecting this document type, you are
certifying that no changes have been made to your product listing since the previous listing was submitted”

COSMETIC
PRODUCTS
A *RED* asterisk
indicates field is
mandatory. A dashed
underline indicates help
text (tool-tips). To list all
the PRODUCTS,
INGREDIENTS and
FACILITIES where the
cosmetic product is
manufactured or
processed, SELECT
ADD PRODUCT(S),
INGREDIENT(S) and
FACILITY(IES).

PRODUCTS, INGREDIENTS AND FACILITIES
Provide all the information required for PRODUCT(S), INGREDIENT(S) and FACILITY(IES)
where the cosmetic product is manufactured or processed.

Fill in all the required fields. PRODUCT LISTING NUMBER is
autogenerated for each PRODUCT.

PRODUCT
CATEGORY
CODE(S)EXAMPLE

Provide the Product Category
Code(s) by selecting the dropdown icon. After selecting
the drop-down icon, SELECT
ALL PRODUCT
CATEGORY CODE(s) that
apply to this submission. The
list can be
minimized/maximized with
the (-) or (+).

LISTING
INGREDIENTS
(EXAMPLE)
Fill in all the INGREDIENTS that are included in this product listing or upload a
prefilled ingredients file. Common, usual or chemical name will auto-populate as
you type along with its UNII.

List of the
complete
ingredients list
will appear
with UNII (if
available)

LIST OF
FACILITY(IES)
(EXAMPLE)
Fill in where the cosmetic product is manufactured or
processed.

If the business is a NOT a
small business, then FEI
is REQUIRED.

If the facility is a small
business and is not
required to register,
then FEI IS NOT
REQUIRED, but will
need to provide the
name and address of
the facility.

LIST OF FACILITY (EXAMPLE)
If the business is a
NOT a small business,
then FEI is
REQUIRED
If the facility is a small
business and is not
required to register,
then FEI IS NOT
REQUIRED, but will
need to provide the
name and address of
the facility.

Once SAVED, the
information will appear
in this table

After verifying the
entered
information is
correct, select
SAVE

EXAMPLE OF
A COMPLETE
LISTING
(PRODUCTS,
INGREDIENTS
AND
FACILITIES
TAB)

PRODUCTS, INGREDIENTS AND FACILITIES
The information that was provided in the pop-up will appear under PRODUCT(S),
INGREDIENT(S) and FACILITY(IES).

Entry CAN BE
EDITED by
selecting this
icon.

For a new entry, select
ADD PRODUCT(S),
INGREDIENT(S), and
FACILITY(IES)

Multiple cosmetic products with
identical formulations, or
formulations that differ only with
respect to color, fragrances or
flavors can be added. By selecting
the CLONE PRODUCT, the
system will COPY the
INGREDIENT LIST and
FACILITY ADDRESS (only) to
SAVE TIME for multiple entry.

After verifying the
entered information
is correct, select
SAVE

EXAMPLE OF
A PREFILLED
CLONE
Any prefilled
information can
be edited.

CONFIRMATION
STATEMENT
A dashed underline indicates help
text (tool-tips) if clicked on, as
listed below.

After understanding the confirmation
statement. Select AGREE

CONFIRMATION
STATEMENT
SIGNATURE
A dashed underline indicates help
text (tool-tips) if clicked on, as
listed below.

By clicking on the signature of submitter
box the USER will be able to provide a
signature

ADDITIONAL CONTACT INFORMATION FOR
AUTHORIZED AGENT
A dashed underline indicates help text (tool-tips) if clicked on, as listed below.

COMPLETED
After filling in all the required information, SAVE AND VALIDATE, to identify any errors.
OR
Select submit SPL for the form to be submitted to FDA.

A Guide that will help the
user understand different
stages such as,
VAILADATE SPL or
SUBMIT SPL.

UPLOAD A FILE
In order to upload a file, select Import an existing Cosmetic Product Listing SPL. Importing an existing
Cosmetic Product Listing SPL will be beneficial for bulk submission.

UPLOAD A FILE
User will be able to upload a pre-existing ZIP FILE, this file may contain both the xml file and image (jpg)
files. For more information regarding SPL, utilize the Structured Product Labeling Resources | FDA
(SPL) link provided under SELF-HELP

UPLOAD A FILE (EXAMPLE)
The content in the red circle is an example to what a zip file could be, may contain .xml file and image
(jpg) files.

ZIP FILE (EXAMPLE)
An example to what an XML format could look like

UPLOAD A FILE (EXAMPLE)
After UPLOADING A FILE (XML ZIP FILE), the system will auto-fill all the required fields and the form will be ready to save and
validate to check for any errors. This is an easy way to submit multiple Cosmetic Product Listing under one submission ID.
VALIDATE SPL: “You can check your SPL for an initial validation before submitting to FDA. This option does not automatically
submit your SPL to FDA, even if it passes the initial validation, but scans for certain errors prior to the actual submission. ”

TOUR
GUIDE

A Guide that will help the
user understand different
submission stage such as,
VAILADATE SPL.

UPLOAD A FILE (EXAMPLE)
Select submit SPL for the form to be submitted to FDA.
The Submit SPL box is a help tool that can guide a user through the process.

PRODUCT LISTING STATUS
EXAMPLES

LISTING STATUS: VALIDATION IN PROGRESS
After SAVE AND VALIDATE, the cosmetic product Listing home page will have the following details as
shown below. The status will be in VALIDATION IN PROGRESS.

HOME

SUBMISSIONS
COSMETIC PRODUCT LISTING

SELF-HELP

MANAGE ACCOUNT

LISTING STATUS: READY FOR SUBMISSION
VALIDATE SPL: You can check your SPL for an initial validation before submitting to FDA. This option does not
automatically submit your SPL to FDA, even if it passes the initial validation, but scans for certain errors prior to the actual
submission. Once the system has completed a quick VALIDATION, the status VALIDATION IN PROGRESS will change
to READY FOR SUBMISSION.

HOME

SUBMISSIONS
COSMETIC PRODUCT LISTING

SELF-HELP

MANAGE ACCOUNT

LISTING STATUS: READY FOR SUBMISSION TO SUBMIT SPL
By clicking on the READY FOR SUBMISSION, the listing will be ready for SUBMIT SPL.
The system will generate a message stating that, This submission has passed the INITIAL VALIDATION but
has NOT been ACTUALLY SUBMITTED TO FDA. Click ON "SUBMIT SPL" to SUBMIT.

LISTING STATUS: SUBMIT SPL TO SUBMISSION ACCEPTED
The status will change to SUBMISSION ACCEPTED after listing had been successfully completed. A SUBMISSION ID
will be given to all ACCEPTED SUBMISSIONS.

HOME

SUBMISSIONS
COSMETIC PRODUCT LISTING

SELF-HELP

MANAGE ACCOUNT

LISTING STATUS: SUBMISSION ACCEPTED to VIEW SPL and
DOWNLOAD SPL
By clicking on the SUBMISSION ACCEPTED the system will allow user to VIEW SPL and DOWNLOAD
SPL.

CREATE A NEW VERSION
By clicking on the CREATE A NEW VERSION, you can clone a successfully-submitted SPL as a starting
point.

LISTING STATUS: VALIDATION FAILURE
After SAVE AND VALIDATE, the cosmetic product listing home page will have the following details as
shown below. The status will be in VALIDATION IN PROGRESS. However, if the system finds any errors
the status will change to VALIDATION FAILURE.

HOME

SUBMISSIONS
COSMETIC PRODUCT LISTING

SELF-HELP

MANAGE ACCOUNT

LISTING STATUS: VALIDATION FAILURE

After selecting the VALIDATION FAILURE status, the system will provide a list of errors, that need to be
fixed before submitting the SPL. After reviewing and fixing the errors, users can select SUBMIT SPL to
resubmit the SPL or SAVE AND VALIDATE to check for any additional errors.

# ERRORS HAVE OCCURRED

* Error Facility FEI Number : (Go to error)
* After reviewing and fixing these errors, select Submit SPL or Save and Validate to resubmit the SPL and check for any additional errors.

LISTING STATUS: DRAFT
By selecting SAVE AS DRAFT, from any screen during the process of cosmetic product listing, the system
will save all information and will bring the user back to the home page. The status will be in DRAFT.

LISTING STATUS: DRAFT
The registration of cosmetic product facility home page will have the following details as shown below.
The status will be in DRAFT.

HOME

SUBMISSIONS
COSMETIC PRODUCT LISTING

SELF-HELP

MANAGE ACCOUNT

COSMETICS DIRECT HOME PAGE

Details…………………………………………………………………..83
All submission ………………………………………………………....84

DETAILS
By clicking on the DETAILS, the system will pop-up PRODUCT LISTING DETAILS box with information
a shown below.

HOME

SUBMISSIONS
COSMETIC PRODUCT LISTING

SELF-HELP

MANAGE ACCOUNT

COSMETICS DIRECT HOME PAGE
ALL SUBMISSION
HOME

SUBMISSIONS

SELF-HELP

MANAGE ACCOUNT