Cosmetics Direct: How to Use FDA's New Submission Portal

What Is Cosmetics Direct?

Cosmetics Direct is the FDA electronic portal specifically designed for MoCRA-mandated facility registration and cosmetic product listing submissions. Launched in 2024, it replaced the legacy VCRP submission process and introduced a modern, structured data format based on the Structured Product Labeling (SPL) standard.

The portal is accessible through FDA's Structured Product Labeling Resources page and requires an FDA Industry Systems (FIS) account with appropriate roles assigned. Unlike the old VCRP paper forms (FDA 2511 and 2512), Cosmetics Direct requires electronic submission using SPL-formatted XML files or the web-based entry interface.

There are two primary functions within Cosmetics Direct:

• Facility Registration: Submitting and maintaining your cosmetics facility registration, including facility details, product categories, and U.S. Agent information (for foreign facilities)
• Product Listing: Listing each cosmetic product marketed in the U.S. with ingredient information, product categories, and the responsible person's contact information

Both submissions are required under MoCRA (FD&C Act §607 and §607A). Failure to register or list products can result in FDA enforcement action, including warning letters, import holds for foreign facilities, and potential product seizure.

Getting Started: Account Setup

Before you can submit anything through Cosmetics Direct, you need the proper account credentials and system access:

1. Create an FDA Industry Systems (FIS) account. Visit the FDA FIS portal and register for an account if you don't already have one. You'll need a valid email address and will receive a verification link.
2. Request SPL access roles. Within your FIS account, request the "SPL Author" and "SPL Submitter" roles. Role approval can take 3–5 business days.
3. Obtain a DUNS number. Your facility must have a Data Universal Numbering System (DUNS) number from Dun & Bradstreet. This identifier is required for facility registration. Obtaining a DUNS number is free but can take up to 30 days. See our DUNS vs FEI guide for details.
4. Designate a U.S. Agent (foreign facilities). If your facility is located outside the U.S., you must have a U.S. Agent designated before you can complete registration. Assurentry can serve as your U.S. Agent.

Plan for at least 2–3 weeks of setup time before your first submission. Account creation, role assignment, and DUNS number acquisition are the most common bottlenecks.

Facility Registration Through Cosmetics Direct

To register your cosmetics facility, you'll submit an SPL document containing your facility information. Here's what you need:

• Facility name and physical address — Must match the actual manufacturing/processing location
• DUNS number — Unique identifier for the facility location (not the parent company)
• Facility type — Manufacturer, packer, repacker, relabeler, or distributor (select all that apply)
• Product categories — Broad categories of cosmetics manufactured or processed at the facility (e.g., skin care, hair care, makeup, fragrance)
• Contact person — Name, email, and phone number of the primary facility contact
• U.S. Agent information (foreign facilities only) — Name, address, phone, and email of the designated U.S. Agent

Once submitted, FDA processes the registration and assigns a registration number. This is different from your FEI number — the Cosmetics Direct registration number is specific to MoCRA. Keep a record of both your submission confirmation and registration number.

Registrations must be renewed biennially (every two years) during the designated renewal window. The first renewal window for MoCRA registrations is anticipated in 2026–2027, but FDA has not yet confirmed specific dates.

Product Listing Through Cosmetics Direct

Each cosmetic product marketed in the U.S. must be listed separately in Cosmetics Direct. Required information for each product listing includes:

• Product name (as it appears on the label)
• Product category — Using FDA's cosmetics product category codes
• Complete ingredient list — Listed in descending order of predominance, using INCI (International Nomenclature of Cosmetic Ingredients) names
• Responsible Person information — The entity whose name appears on the product label, including domestic contact information for adverse event reporting
• Facility registration number — Linking the product to the registered facility where it is manufactured

Product listings must be updated within 60 days of any change to the listed information (new ingredients, reformulation, etc.) and annually if no changes have occurred. New products must be listed within 120 days of being introduced to the U.S. market (21 CFR §607A).

Common Cosmetics Direct Errors and How to Fix Them

Based on industry experience with the portal since its launch, these are the most common errors that delay or reject submissions:

• SPL validation errors. The SPL format has strict XML schema requirements. Common issues include missing required fields, incorrect data types, and malformed XML. If using the web interface rather than manual XML creation, most formatting issues are handled automatically.
• DUNS number mismatch. The DUNS number in your submission must exactly match the number registered with Dun & Bradstreet. If your company name or address has changed, update your DUNS record first.
• Incorrect product category codes. FDA uses specific category codes that don't always map intuitively to common product descriptions. A "BB cream" might need to be listed under both makeup and skin care categories.
• Missing U.S. Agent confirmation. For foreign facilities, the U.S. Agent must separately confirm their designation in the system. Submissions will not complete without this confirmation.
• Incomplete ingredient lists. Every ingredient must be listed using INCI nomenclature. Fragrance and flavor can be listed as such (for now — see upcoming fragrance allergen rules), but all other ingredients need specific INCI names.
• Timeout issues during peak periods. Like other FDA portals, Cosmetics Direct can experience slowdowns during high- traffic periods. Save your work frequently and avoid submitting during the last day of a deadline.

Tips for a Smooth Submission Process

To minimize delays and rejections, follow these best practices:

1. Prepare all data before starting. Gather your DUNS number, facility details, U.S. Agent information, and complete ingredient lists for all products before logging into the portal.
2. Submit facility registration first. You need a facility registration number before you can list products. Complete registration and wait for your registration number before starting product listings.
3. Use INCI names from the start. Don't use trade names or common names for ingredients. The system may reject submissions with non-standard nomenclature.
4. Keep confirmation receipts. After every successful submission, download or screenshot the confirmation. FDA does not always send email confirmations.
5. Coordinate with your U.S. Agent. If you're a foreign facility, ensure your U.S. Agent is ready to confirm designation immediately after you submit your registration.
6. Track update deadlines. Set calendar reminders for the 60-day update window (product changes) and annual reaffirmation requirement.