Cosmetic products must complete FDA registration before exporting to the United States. Under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022, the 2025 FDA cosmetic registration process primarily includes two core steps: Facility Registration and Product Listing. Here are the specific procedures and requirements:
1. Facility Registration
Applicable Entities: All domestic and foreign enterprises that manufacture, process, or package cosmetics in the United States.
Required Materials:
DUNS Number (mandatory requirement)
Facility address, production facility floor plan, contact information
Validity Period:
Must be updated every two years (by December 31 of even-numbered years)
Exemption Conditions:
Small businesses may be exempt, but this does not apply to products intended for eye area use.
2. Product Listing
Coverage Scope: Each individual cosmetic product sold in the United States.
Submission Content:
Product name, INCI standard ingredient list (arranged in descending order of content)
Product category (e.g., skincare, makeup, etc.)
Update Frequency:
Must be updated annually.
Key MoCRA Requirements
Responsible Party:
Cosmetic manufacturers, packers, or distributors must act as the "Responsible Person" to complete registration.
Special Requirements:
Products claiming efficacy such as "acne treatment" or "SPF 30+ sunscreen" require additional approval under OTC drug standards.
Must exclude prohibited ingredients such as hydroquinone and comply with restricted ingredient requirements (e.g., oxybenzone content ≤6%).
Registration Process Overview
Pre-Compliance Assessment (Start 6 months in advance): Clarify product attributes (cosmetic vs. OTC drug) and verify ingredient compliance.
Facility Registration: Submit information through FDA account to obtain FEI (Facility Establishment Identifier) number.
Product Listing: Submit ingredient list and related documents to complete filing.
Review and Approval: FDA may request additional information or conduct on-site inspections before making final approval decision.
Need professional assistance with FDA cosmetic registration?
Contact our compliance experts to ensure your products meet all MoCRA requirements and successfully enter the U.S. market.
