Cosmetic Product and Facility Registration Guide: MoCRA Cosmetics Direct Walkthrough

What Is Cosmetics Direct?

Cosmetics Direct is the FDA's electronic submission portal for cosmetic facility registration and product listing. Launched in 2023 to implement MoCRA requirements, it replaces the previous Voluntary Cosmetic Registration Program (VCRP). Unlike the VCRP, registration through Cosmetics Direct is mandatory for most cosmetic product facilities.

The system is accessible at cosmetics.fda.gov and requires an FDA Industry Systems (FIS) account. Both domestic and foreign facilities must use Cosmetics Direct for submissions.

Who Must Register Under MoCRA?

MoCRA requires registration for any facility that engages in the manufacturing or processing of a cosmetic product for distribution in the United States. This includes:

• Domestic manufacturers: Any US-based facility that manufactures, packages, or labels cosmetic products
• Foreign manufacturers: Facilities outside the US that manufacture cosmetics exported to the US market
• Contract manufacturers: Third-party facilities producing cosmetics on behalf of brand owners
• Re-packers and re-labelers: Facilities that change the packaging or labeling of cosmetic products

Exemptions

Certain entities are exempt from MoCRA facility registration:

• Facilities that exclusively manufacture cosmetics for research or evaluation, not for retail sale
• Small businesses with average gross annual sales under $1 million over the preceding 3-year period that manufacture products without certain specified ingredients
• Beauticians and cosmetologists who manufacture cosmetics for use at their own establishments

Facility Registration Requirements

Each facility registration through Cosmetics Direct requires the following information:

• Facility name and address: Full physical address of the manufacturing or processing site
• DUNS Number: A Data Universal Numbering System identifier is required for facility identification
• FDA Establishment Identifier (FEI): If already assigned from prior FDA registration activities
• Contact information: Name, email, and phone number for the responsible person
• Product categories: The broad categories of cosmetic products manufactured at the facility
• US Agent (foreign facilities): Foreign facilities must designate a US-based agent for FDA communication

Annual Renewal

Cosmetic facility registrations must be renewed between October 1 and December 31 of each year. Failure to renew results in cancellation of the registration. The renewal process requires confirming existing information is accurate or updating any changes.

Product Listing Process

After registering your facility, you must list each cosmetic product manufactured at that facility:

• Product name: The brand name and product name as it appears on the label
• Product category: Selected from FDA's predefined cosmetic product categories
• Ingredient list: Complete listing of all ingredients using INCI nomenclature
• Responsible person: The manufacturer, packer, or distributor whose name appears on the product label
• Facility association: Linking the product to the registered manufacturing facility

Step-by-Step Cosmetics Direct Walkthrough

Step 1: Create an FDA Industry Systems Account

Before accessing Cosmetics Direct, you need an FIS account at access.fda.gov. This involves identity verification and may take several business days. Foreign users may also need an FDA FURLS account.

Step 2: Register Your Facility

Navigate to the Cosmetics Direct portal and select Facility Registration. Enter your facility details including the DUNS number, physical address, contact information, and product categories manufactured. Foreign facilities must provide US Agent information.

Step 3: Submit Product Listings

After facility registration is confirmed, select Product Listing and enter each product's details. You can submit listings one at a time or use the bulk upload feature for larger catalogs. Each listing must include the complete ingredient list in INCI format.

Step 4: Review and Confirm

Review all submitted information for accuracy before final confirmation. The system will generate an FDA Cosmetic Registration Number upon successful submission. Save this number for your records.

Common Registration Mistakes

Labeling and Adverse Event Reporting

MoCRA introduced mandatory adverse event reporting for cosmetic products. The responsible person must:

• Report serious adverse events to the FDA within 15 business days
• Maintain records of all adverse events for 6 years
• Include contact information for adverse event reporting on the product label

For labeling guidance, see our MoCRA compliance guide.

How Assurentry Can Help

Assurentry provides end-to-end MoCRA compliance support for cosmetic companies:

• Cosmetics Direct registration: We handle facility registration and product listing submissions
• US Agent services: Foreign manufacturers can designate Assurentry as their US Agent
• Ingredient review: We verify INCI nomenclature and ingredient compliance
• Renewal management: Automated reminders and annual renewal handling
• Adverse event reporting: Guidance on establishing compliant reporting systems