FDA Cosmetic Registration: MoCRA Product Listing Requirements

Understanding FDA Cosmetic Registration and MoCRA Obligations

FDA cosmetic registration is now a requirement under the Modernization of Cosmetics Regulation Act (MoCRA), signed into law in December 2022. This regulation introduces mandatory listing obligations for all cosmetic products marketed in the United States. Every cosmetic item must be registered with the FDA by a designated Responsible Person before sale.

Who Needs to Complete Cosmetic Product Listings?

The Responsible Person—defined as the manufacturer, packer, or distributor listed on the product label—is responsible for completing FDA cosmetic product registration/listings. This applies to:

• Domestic and international cosmetic manufacturers
• Brand owners and private-label distributors
• Contract manufacturers (if listed on labels)

Required Information for Cosmetic Registration

Each listing submitted through the FDA’s Cosmetics Direct Portal must include:

• Brand and product name
• Cosmetic category (e.g., shampoo, body lotion, lip gloss)
• Intended use and usage instructions
• Full ingredient declaration, including fragrance and colorants
• Facility where the product is made or processed

Variations in packaging, volume, or color must be addressed during submission.

Deadlines for Cosmetic Product Registration

• Initial compliance deadline: December 29, 2023
• New products: Must be listed within 120 days of being introduced to the US market
• Annual updates: Required for substantial changes in label or formulation

How to Register with the FDA via Cosmetics Direct

The FDA’s Cosmetics Direct Portal allows electronic submission of product listings. Responsible Persons must:

• Log in to the Cosmetics Direct platform
• Create or maintain their facility record
• Submit product information manually or through XML file upload

Key Compliance Issues in Cosmetic Registration

• Variants and shared formulas must be declared separately
• Disclosure of certain fragrance allergens is expected under upcoming rules
• A designated US Agent is required for Responsible Persons based outside the US

Cosmereg’s Registration Support Services

Cosmereg helps streamline your MoCRA FDA cosmetic registration compliance by:

• Preparing and submitting structured FDA cosmetic product listings
• Managing your Cosmetics Direct Portal profile
• Supporting listing updates and compliance revisions
• Acting as your US Agent for FDA communication

Why Timely Cosmetic Registration Matters

Failure to meet  FDA cosmetic registration and MoCRA’s product listing requirements can result in:

• Import delays or rejections
• Enforcement notices
• Loss of distributor confidence

Cosmereg ensures your product listings meet FDA cosmetic registration requirements efficiently and on time.

Need help with FDA registration of your cosmetic products?
Let Cosmereg manage your MoCRA listing process from start to finish, contact us