FDA Cosmetics Direct: How to Register Your Facility Step by Step (2026)

Published by US Compliance Agent LLC

FDA's Cosmetics Direct portal is the electronic system where foreign cosmetics manufacturers register their facilities and list their products under MoCRA. If you are in the middle of the registration process and need clear, step-by-step instructions, this guide walks you through exactly what to do.

Before You Start

Make sure you have the following ready before you log into Cosmetics Direct:

Your FEI number. An FDA Establishment Identifier is required to complete your registration. If you do not have one, search the FEI portal at FDA.gov or email feiportal@fda.hhs.gov with your facility name, full address, and contact information. FDA will assign one — this usually takes a few business days.

Your FDA account credentials. You need an FDA account to access Cosmetics Direct. If you do not have one, create an account at FDA's Industry Systems page. You will need a valid email address. FDA will send a verification email.

Your U.S. Agent's information. You will need the full name, physical U.S. address, phone number, and email of your designated U.S. Agent. This is a required field — the system will not allow you to complete registration without it. If you do not yet have a U.S. Agent, arrange for one before starting.

Your facility information. Legal name of your facility, physical address (the actual manufacturing location), phone number, email, and the name of the facility owner or parent company.

Your product information. Brand names, product categories (from FDA's standardized list), and ingredient lists for each cosmetic product manufactured at your facility.

Responsible Person information. The name and contact information of the Responsible Person for each product — typically the U.S. brand owner or importer whose name appears on the product label.

Step 1: Access Cosmetics Direct

Go to direct.fda.gov and log in with your FDA account credentials.

If this is your first time using Cosmetics Direct, the system will walk you through an initial setup process. Follow the prompts to verify your account and agree to the terms of use.

Once logged in, you will see the main dashboard with options for facility registration and product listing.

Step 2: Start Your Facility Registration

Select "Registration of Cosmetic Product Facility" from the main menu.

Click "Create New" to begin a new facility registration.

The system will guide you through several sections. Complete each one in order.

Step 3: Enter Facility Information

Facility name. Enter the legal name of your manufacturing or processing facility. This should be the official name of the facility, not a brand name or trade name.

Facility address. Enter the full physical address of the facility where cosmetics are manufactured or processed. For foreign facilities, make sure you select the correct country. Some international address formats may need adjustment to fit FDA's system fields.

Facility type. Select the activities performed at your facility — manufacturing, processing, packing, or holding cosmetic products. Select all that apply.

Owner/operator. Enter the name and contact information of the entity that owns or operates the facility. If the facility is owned by a parent company, include that information.

FEI number. Enter your FDA Establishment Identifier. If the system does not recognize your FEI, verify that you have the correct number or that it has been properly assigned by FDA.

Step 4: Enter Your U.S. Agent Information

This section is required for all foreign facilities. Enter the following for your U.S. Agent:

Agent name. The full legal name of your U.S. Agent — whether a person or a company.

Physical U.S. address. The agent's street address in the United States. This must be a real physical address — P.O. Boxes are not accepted.

Phone number. A U.S. phone number where the agent can be reached during U.S. business hours.

Email address. The agent's email address for receiving electronic correspondence from FDA.

Double-check all information before proceeding. Errors in your U.S. Agent information can cause problems later if FDA attempts to contact your facility and cannot reach the agent.

Step 5: Enter Product Information

For each cosmetic product manufactured or processed at your facility, enter:

Brand names. All brand names under which the products are sold in the United States.

Product categories. Select from FDA's standardized list of cosmetic product categories. These include baby products, bath preparations, eye makeup preparations, fragrance preparations, hair preparations (non-coloring), hair coloring preparations, makeup preparations, manicuring preparations, oral hygiene products, personal cleanliness products, shaving preparations, skin care preparations, and tattoo preparations.

Responsible Person. For each product, identify the Responsible Person — the entity whose name appears on the product label. This is typically the U.S. brand owner, importer, or distributor. The Responsible Person is accountable for adverse event reporting, labeling compliance, and safety substantiation.

Step 6: Review and Submit

Before submitting, review all information carefully:

• Is your facility name and address correct?

• Is your FEI number accurate?

• Is your U.S. Agent information complete and correct?

• Have you listed all product categories and brand names?

• Is the Responsible Person information accurate for each product?

Once you are satisfied that everything is correct, click "Validate" to check for errors. The system will flag any required fields that are missing or any formatting issues.

Fix any errors, then click "Submit."

Step 7: Confirmation

After successful submission, the system will display a confirmation message and your registration will be recorded in FDA's system. Your facility status should show as "Submission Accepted."

Save or print your confirmation for your records. You may also receive an email confirmation from FDA.

At this point, your facility is registered, your U.S. Agent is on file, and your products are listed. You are compliant with the facility registration and product listing requirements of MoCRA.

After Registration: What to Maintain

Biennial renewal. Your facility registration must be renewed every two years in Cosmetics Direct. FDA will send reminders through your U.S. Agent as the renewal date approaches.

Update changes. If any of the following change, update your registration in Cosmetics Direct within 60 days: facility name or address, ownership, U.S. Agent, product categories, brand names, or contact information.

Product listing updates. If you launch new products, discontinue products, or change formulations, update your product listings accordingly.

Adverse event reporting. If a serious adverse event is associated with one of your products, the Responsible Person must report it to FDA within 15 business days. Your U.S. Agent serves as a relay point for any adverse event inquiries from FDA.

Common Problems and How to Fix Them

FEI number not recognized. If the system does not accept your FEI, email feiportal@fda.hhs.gov to verify your number or request a new one.

U.S. Agent field will not accept entry. Make sure you are entering a physical U.S. street address, not a P.O. Box. Verify the format matches what the system expects (street, city, state, ZIP code).

Cannot find your product category. Review FDA's full list of MoCRA product categories in Appendix A of FDA's facility registration guidance. If your product does not fit a listed category, select the closest match and add clarification in the product description if possible.

Submission rejected. Click "Validate" before submitting to identify specific errors. The most common issues are missing required fields, incorrect address formatting, or invalid FEI numbers.

Getting Help

If you need a U.S. Agent to complete your facility registration, US Compliance Agent can have you set up within one business day. Our MoCRA service is $249 per year and includes your U.S. Agent designation letter with all the contact details you need to enter into Cosmetics Direct.

Visit our MoCRA U.S. Agent service page to get started.

US Compliance Agent LLC is a private company. We are not affiliated with, endorsed by, or connected to the FDA or any U.S. government agency. We do not provide legal advice, regulatory consulting, product testing, or certification services.