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  4. Form FDA 5067 - Cosmetic Product Listing
  1. Registration & Listing of Cosmetic Product Facilities and Products

Form FDA 5067 - Cosmetic Product Listing

Electronic Submissions 

FDA strongly encourages electronic submissions to facilitate efficiency and timeliness of data submission and management for the agency.

  • Cosmetics Direct: You can submit your facility registrations using the Cosmetics Direct electronic submission portal at: https://direct.fda.gov.
  • Electronic Submissions Gateway (ESG): As an alternative, facility registrations may be submitted online through FDA’s ESG, or any Structured Product Labeling (SPL) authoring software including SPL Xforms. The FDA ESG system requires users to apply for a free account before submitting data, a process which can take one to three weeks. FDA therefore urges registrants to apply for ESG accounts well in advance of the statutory deadline for data submission. The FDA ESG system requires users to apply for a free account before submitting data, a process which can take one to three weeks. FDA therefore urges registrants to apply for ESG accounts well in advance of the statutory deadline for data submission.

Paper Submissions 

Instructions to Complete Form FDA 5067 – Cosmetic Product Listing

Download Form FDA 5067

Please mail the completed form to FDA’s Registration and Listing of Cosmetic Product Facilities and Products Program at: 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 it to RLC-PaperSubmissions@fda.hhs.gov.

The paper Form FDA 5067 contains six sections (Sections I through VI). All required fields on Form FDA 5067 are designated by asterisks (*).

For additional details and instructions, please refer to the FDA Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products.

Note: A single listing submission for a cosmetic product may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.

Enter the product listing number(s), if previously assigned. Then follow the instructions below to complete Sections I through VI.

Section I – Document type

Select one of the following document types:

  • Initial Listing – Form FDA 5067 submitted to FDA for the first time to provide information about a cosmetic product.
  • Update to Content (annual) Changes to Listing – Form FDA 5067 submitted to FDA to make changes to a Cosmetic Product Listing.
  • Update to Content (annual) Discontinuation of Listing – Form FDA 5067 submitted to FDA for a cosmetic product that is no longer marketed in the United States.
  • Abbreviated Renewal – Form FDA 5067 submitted to FDA to renew a Cosmetic Product Listing without any changes. By selecting this document type, you are certifying that no changes have been made to your product listing since the previous listing was submitted.

Section II – Product listing

Provide the following required information:

  • Responsible person name (as listed on label)
  • Responsible person contact phone number (including country/area code)
  • Product category code(s) (see Cosmetic Product Categories and Codes)
  • Product name (as listed on label)
  • Identify whether the product contains fragrance and/or flavor (select one or both, if applicable)

Note:

In the product name field, enter the statement of identity, as such name appears on the label. If the product names in the listing are not unique, then also include distinguishing information for identification purposes, for example brand name or a code that the responsible person uses to distinguish the product. Such information may also be included in addition to the product name even when product names in the listing are unique. If you believe certain distinguishing information is confidential, include that distinguishing information in parenthesis.

FDA also requests that the following additional optional information be provided:

  • Whether the product listing is for a small business (optional product listing)
  • Responsible person: type of business (as listed on the label); manufacturer, packer, or distributor (or any combination of these types)
  • Parent company name (if applicable)
  • Responsible person DUNS Number for address listed on product label
  • Image of the label (attach images of the front and back product labels to the form)
  • Product webpage link
  • Whether the cosmetic product is for professional use only

Note:

Responsible Person as defined in section 604(4) of the Federal Food Drug, and Cosmetic Act (FD&C Act), means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Section III – List of facilities where the cosmetic product is manufactured or processed

Provide the following required information:

  • FDA establishment identifier (FEI) of each facility(ies) where the product is manufactured or processed. If the facility is exempt from registration, for example because it is a small business, please check the box.

If the exempt facility has no facility registration number, the facility name/address can be provided instead.

Note:

To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. To determine if an entity already has an FEI number, please refer to the FEI Search Portal. If your firm does not have an FEI number assigned by FDA, see How can I request an FEI? at FEI Search Portal (fda.gov).

Section IV – List of ingredients in the cosmetic product

Provide the following required information:

  • A list of ingredients in the cosmetic product, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations, or by the common or usual name of the ingredient.
  • Indicate which ingredients apply to which product(s)

When submitting the document type “Update to Content (annual) Changes to Listing”, please include all ingredients in the cosmetic product, not just the ingredients with changes.

FDA also requests that the following additional optional information be provided:

Section V – Confirmation statement

Enter the requested information in this section. FDA requests that individuals submitting product listing information to attest to the accuracy and veracity of the information submitted.

Section VI – Additional contact information for authorized agent

Provide the following optional information:

  • Additional contact name
  • Additional contact email
  • Additional contact phone number (including country/area code)
  • Additional contact phone extension

Before submitting Form FDA 5067, please check your submission to ensure that all continuation pages and/or attachments have been included. The mailing and email addresses for the submission can be found at the top of this webpage.

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