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MoCRA

MoCRA Product Listing Requirements: What You Need to Know

MoCRA requires every cosmetic product marketed in the U.S. to be listed with FDA. Learn the required data, deadlines, and common listing errors to avoid.

Quick Answer

MoCRA requires the Responsible Person to list each cosmetic product marketed in the U.S. with FDA through the Cosmetics Direct portal. Listings must include the product name, category, ingredient list, and Responsible Person details. New products must be listed within 120 days of entering the market.

What Is MoCRA Product Listing?

Product listing is one of the core requirements of the Modernization of Cosmetics Regulation Act (MoCRA), codified in FD&C Act Section 607(c). Unlike the old Voluntary Cosmetic Registration Program (VCRP), which was optional, MoCRA makes product listing mandatory for every cosmetic product marketed in the United States.

Product listing is separate from facility registration. While facility registration tells FDA where cosmetics are made, product listing tells FDA what products are being sold and what ingredients they contain. Both are required for full MoCRA compliance.

The Responsible Person — typically the manufacturer, packer, or distributor whose name appears on the product label — is responsible for submitting and maintaining product listings.

Required Information for Each Listing

Each product listing submitted through Cosmetics Direct must include:

  • Product name: The brand name and product name as they appear on the label
  • Product category: FDA's standardized cosmetic product category (e.g., skin cleansing creams and lotions, shampoos, lipstick)
  • Responsible Person: Name and contact information of the entity listed on the product label
  • Facility registration number: The FDA registration number of each facility that manufactures or processes the product
  • Complete ingredient list: All ingredients in descending order of predominance, using INCI (International Nomenclature of Cosmetic Ingredients) names or other FDA-accepted nomenclature

FDA has proposed future requirements for fragrance allergen disclosure, but as of early 2026, the NPRM (Notice of Proposed Rulemaking) has not been finalized. Companies should monitor FDA's rulemaking calendar for updates.

Deadlines and Timing

MoCRA establishes the following timing requirements for product listing:

  • Existing products: Products that were already on the market when MoCRA took effect should have been listed by December 29, 2024 (one year after the small business exemption window). Companies that have not yet listed existing products should do so immediately to avoid enforcement risk.
  • New products: Products entering the U.S. market for the first time must be listed within 120 days of the date of marketing, per FD&C Act Section 607(c)(1).
  • Discontinued products: Listings should be updated or removed when a product is permanently discontinued from the U.S. market.
  • Formulation changes: If the product's ingredient list changes, the listing must be updated within 60 days.

Common Product Listing Mistakes

Based on FDA's experience with the first year of MoCRA product listings, these are the most common errors:

  • Incomplete ingredient lists: Omitting fragrances, colorants, or sub-ingredients of compound ingredients. FDA expects full ingredient disclosure under MoCRA.
  • Wrong product category: Misclassifying products can trigger FDA scrutiny. For example, listing a tinted moisturizer with SPF under "moisturizers" instead of the proper sunscreen/drug category.
  • Listing by brand instead of formulation: If multiple brand names share the same formulation, they still need separate listings if they have different product labels.
  • Forgetting contract-manufactured products: Brand owners must list products even when a contract manufacturer produces them. The Responsible Person is the entity on the label, not necessarily the manufacturer.
  • Not linking to facility registration: Each product listing must reference the facility registration number where the product is manufactured. Ensure your facility is registered first.

Need help with MoCRA product listing?

Assurentry manages product listings for brands with 10 to 10,000+ SKUs. We handle Cosmetics Direct submissions, ingredient formatting, and ongoing updates.

Get Product Listing Help

How Assurentry Simplifies Product Listing

Managing product listings manually through Cosmetics Direct can be time-consuming, especially for companies with large product portfolios. Assurentry's MoCRA compliance services include:

  • Bulk product listing submissions for companies with many SKUs
  • Ingredient list formatting and INCI nomenclature verification
  • Ongoing listing maintenance as formulations change or products are added/discontinued
  • U.S. Agent services for foreign Responsible Persons
  • Compliance monitoring to ensure all listings remain current

Whether you have 10 products or 10,000, Assurentry's MoCRA services ensure your product listings are accurate, timely, and compliant.

Product Listing Compliance Starts Here

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