FDA Cosmetic Product Listing

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Instructions

Please read carefully before completing this form

For faster processing please use the electronic submission portal at: https://direct.fda.gov. Type all entries in CAPITAL LETTERS. An item followed by an asterisk (*) denotes a required field. Use standard abbreviations wherever possible. Omit all punctuation.

For Section IV: List each ingredient on a separate row, in the order they are listed on the label. If the Unique Ingredient Identifier (UNII) is not known, leave UNII blank. List additional ingredients on a separate page-2 of Form FDA 5067.

Mail completed form to: Department of Health and Human Services, Food and Drug Administration, Office of Cosmetics and Colors, Registration and Listing of Cosmetic Product Facilities and Products Program, 5001 Campus Drive, CPK1, Room 1B-046, College Park, MD 20740-3835 or email to [email protected].

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Product Listing Numbers

If previously assigned by FDA — leave blank for initial submissions

Product No.	Product Listing Number(s) (if previously assigned)
1
2
3

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Section I — Document Type

Select the type of submission you are making

Document Type *

Initial First-time listing of this cosmetic product with FDA.

Update to Content (annual) Annual update to your cosmetic product listing information.

Changes to Listing Discontinuation of Listing

Abbreviated Renewal By selecting this option, you are certifying that no changes have been made to your product listing since the previous listing was submitted.

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Section II — Product Listing

Responsible person information and product details

Small Business listing? (optional)

YES NO

Responsible Person: Type of Business (as listed on label)

Manufacturer Packer Distributor

Responsible Person Name * (as listed on label)

Parent Company Name (if applicable)

Responsible Person Contact Phone Number * include country/area code

Responsible Person D&B D-U-N-S Number for address listed on product label

Product Category Code(s) * see references

Image of Label (attach front and back product label images)

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Click to upload label images

JPG, PNG or PDF accepted

Product Webpage Link (optional)

Products * — list each product name as it appears on the label

#	Does This Product Contain Fragrance or Flavor?	Professional Use Only?
1	Fragrance Flavor	YES NO
2	Fragrance Flavor	YES NO
3	Fragrance Flavor	YES NO

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Section III — List of Facilities Where the Cosmetic Product Is Manufactured or Processed

See product number/product name provided in Section II

Provide the FDA Establishment Identifier (FEI) for each facility. If the facility is exempt from registration (e.g., a small business), check the exempt box. If the exempt facility has no FEI number, enter the facility name and address instead.

Prod. No.	FDA Establishment Identifier (FEI) of Each Facility Where the Product Is Manufactured or Processed *	Exempt from Registration?
1		Exempt
2		Exempt
3		Exempt

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Section IV — List of Ingredients in the Cosmetic Product

Fragrances and flavors are included in Section II and do not need to be listed here

List each ingredient on a separate row, in the order they appear on the label. If the Unique Ingredient Identifier (UNII) is not known, leave the UNII column blank. Find UNIIs at: https://precision.fda.gov/uniisearch

No.	Common, Usual, or Chemical Name *	Unique Ingredient Identifier (UNII)	Product Number(s) *

List additional ingredients on a separate page-2 of Form FDA 5067 if needed.

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Section V — Confirmation Statement

Certification and signature of submitter

The data and information in this submission have been reviewed and, to the best of my knowledge, are certified to be true and accurate. I agree to report changes to this information as required under section 607 of the FD&C Act.

WARNING: A willfully false statement is a criminal offense, U.S. Code, Title 18, Section 1001.

I Agree — I certify the above statement is true and accurate *

Submitter Information

Signature of Submitter *

Printed Name of Submitter *

Title / Position

Date

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Section VI — Additional Contact Information for Authorized Agent

Optional — provide if an authorized agent is submitting on behalf of the responsible person

Additional Contact Name

Email

Phone Number include country/area code

Phone Extension

Cosmetic Product Listing

Instructions

Product Listing Numbers

Section I — Document Type

Section II — Product Listing

Section III — List of Facilities Where the Cosmetic Product Is Manufactured or Processed

Section IV — List of Ingredients in the Cosmetic Product

Section V — Confirmation Statement

Section VI — Additional Contact Information for Authorized Agent

Listing Submitted