Form FDA 5067 - Cosmetic Product Listing
Electronic Submissions
- Cosmetics Direct: You can submit your product listings using the Cosmetics Direct electronic submission portal at: https://direct.fda.gov.
- Electronic Submissions Gateway Next Generation (ESG NextGen): As an alternative, product listings may be submitted online through FDA’s ESG NextGen, or any Structured Product Labeling (SPL) authoring software including SPL Xforms. The FDA ESG NextGen 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 NextGen accounts well in advance of the statutory deadline for data submission.
Paper Submissions
Instructions to Complete Form FDA 5067 – Cosmetic Product Listing
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) – Form FDA 5067 submitted to FDA to make changes to a Cosmetic Product Listing. The responsible person must provide any updates to such listing annually (section 607(c)(5) of the FD&C Act). This includes an update that the product was discontinued.
- Changes to Listing: Provide any changes to previous cosmetic product listing.
- Discontinuation of Listing: Provide an update to inform FDA that a previously listed cosmetic product 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
The following information is required:
- Responsible person name (as listed on label)1
- Responsible person's contact phone number (including country/area code)
- Product category code(s) (see)2
- Product name (as listed on label)3
- Identify whether the product contains fragrance and/or flavor (select one or both, if applicable)
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
Notes:
1 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.
2 A product category code may have multiple product category components (e.g., primary, secondary, and tertiary product categories). Each primary product category (01 – 16, but not 17) has multiple secondary product categories (e.g., A through K for 03). A secondary product category can have several tertiary product categories (e.g. 1. Leave-on and 2. Rinse-off for 06A). For example, a hair preparation (non-coloring) product that is a hair conditioner and a rinse-off product would have a product category code of 06A2. A cosmetic product listing can have only one tertiary product category that is either a “leave-on” or “rinse-off”, but not both (e.g., product category 06A1 or 06A2).
Additional information can be found at: Cosmetic Product Categories and Codes
Product Category Codes Diagram:
Product Category Code Examples:
Example 1: Hair Conditioner; Rinse-off
Cosmetic Product Category Code: 06A2
| Primary Product Category | Secondary Product Category | Tertiary Product Category |
| (06) Hair Preparations (non-coloring) | A- Hair Conditioners | 2- Rinse Off |
Example 2: Bubble Bath
Cosmetic Product Category Code: 02B
| Primary Product Category | Secondary Product Category | Tertiary Product Category |
| (02) Bath Preparations | B- Bubble Baths | Not applicable |
Example 3 below depicts a 3-in-1 product that would have multiple product category codes and multiple functions.
Example 3: 3-in-1 Shampoo, Bubble Bath, & Body Wash
Cosmetic Product Category Code: 06F2, 02B, 12A
| Primary Product Category | Secondary Product Category | Tertiary Product Category |
| (06) Hair Preparations (non-coloring) | F- Shampoos (non-coloring) | 2- Rinse Off |
| (02) Bath Preparations | B- Bubble Baths | Not applicable |
| (12) Personal Cleanliness | A- Bath Soaps and Body Washes | Not applicable |
3 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.
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:
The owner or operator of a facility would have needed to obtain an FEI number before submitting a cosmetic product 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:
- Unique ingredient Identifiers (UNIIs) (see FDA's Global Substance Registration System - UNII Search Service)
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.