FDA Registration of Cosmetic Product Facility

AuthorityFD&C Act §607(a) & (b) OMB0910-0599 ExpirationDecember 31, 2026 Required forAll cosmetic product facilities

Instructions

Section I

Section II

Section III

Section IV

Section V

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Instructions

Please read 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. Complete a separate Form FDA 5066 for each facility location.

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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Section I — Document Type

Select the type of submission you are making

Document Type *

Initial First-time registration of this cosmetic product facility with FDA.

Amended Update or correct information in a previously submitted registration.

Changes to Registration Cancellation of Registration

Biennial Registration Renewal Renew registration every two years as required under section 607 of the FD&C Act.

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

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Section II — Registration

Facility information and product details

Is this a facility registration for a Small Business? (optional registration)

YES NO

Facility Name *

Parent Company Name (if applicable)

Facility FEI (FDA Establishment Identifier) Number *

Facility D&B D-U-N-S Number (if applicable)

Street Address *

City *

State or Province *

ZIP / Postal Code *

Country * if other than USA

Facility Email *

Facility Phone Number * include country/area code

Name of the Owner and/or Operator of the Facility *

Brand Names of Cosmetic Products Manufactured or Processed in this Facility *

Brand Name of Cosmetic Product	Responsible Person Name (as listed on label)	Product Category Code(s) (see references)
1.
2.
3.

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Section III — U.S. Agent Contact Information

For foreign facilities only

Complete this section only if your facility is located outside the United States. The U.S. Agent must reside or maintain a place of business in the United States and must be available to FDA during normal business hours.

U.S. Agent Name * for foreign facilities

Email * if not available, enter "N/A"

Phone Number * include country/area code

Phone Extension

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Section IV — 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 and renew 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 V — Additional Contact Information for Authorized Agent

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

Additional Contact Name

Phone Number include country/area code

Phone Extension

Registration of Cosmetic Product Facility

Instructions

Section I — Document Type

Section II — Registration

Section III — U.S. Agent Contact Information

Section IV — Confirmation Statement

Section V — Additional Contact Information for Authorized Agent

Registration Submitted