Cosmetics Direct is FDA’s electronic portal for cosmetic facility registration and product listing. If you are new to MoCRA compliance, the portal can feel intimidating – but the process is straightforward once you know the steps and have your information ready.
This walkthrough covers everything from prerequisites to submission, including what FDA expects at each stage and the mistakes that cause the most delays.
Before you start: what you need
Gather these before logging in. Having them ready turns a multi-day scramble into a single focused session:
- FEI number. Your Facility Establishment Identifier, requested from feiportal@fda.hhs.gov (allow 7-10 business days).
- U.S. agent information. Foreign facilities must designate a U.S. agent – name, address, phone, and email.
- Facility details. Legal name, physical address, and contact information for the site.
- Product types. The categories of cosmetics manufactured or processed at the facility.
- Authorization. If an agent or third party files on your behalf, written authorization to act for the facility.
Step-by-step: registering your facility
- Access Cosmetics Direct. Navigate to FDA’s Cosmetics Direct portal and create an account or log in. The portal is free – there are no access fees.
- Select the latest SPL version. Cosmetics Direct uses Structured Product Labeling (SPL) format. Always select the most current SPL version for your submission – FDA updates it periodically, and outdated versions cause rejections.
- Choose the correct submission type. For a first-time facility registration, select the facility registration option (not renewal, not product listing). Each submission type has its own form.
- Enter facility information. Input the legal name, physical address, FEI number, and contact details. Double-check the FEI – a typo here is one of the most common errors.
- Designate the U.S. agent (foreign facilities). Enter your agent’s full contact information. The agent’s email becomes the address on file for FDA correspondence, including renewal reminders.
- Select product types. Indicate which categories of cosmetic products the facility manufactures or processes.
- Review everything. Before submitting, review every field. The registration becomes part of your official FDA record – errors require amendments later.
- Submit and save the confirmation. After submission, save the Submission ID and confirmation. This is your proof of filing – FDA does not issue certificates.
After you submit
FDA processes electronic submissions faster than paper. You should receive confirmation of receipt. Keep the Submission ID with your regulatory records permanently – you will need it for renewals, amendments, and any correspondence with FDA about the registration.
If FDA finds an issue with your submission, you will be notified through the contact information on file. This is another reason the U.S. agent’s email accuracy matters – missed notifications mean missed deadlines.
Keeping your registration current
Registration is not a one-time task. Your facility registration must be renewed every two years from the initial registration date, and you should update it promptly if facility details, contact information, or your U.S. agent changes. Cosmetics Direct now displays your registration status and renewal date, making it easy to track. Set a calendar reminder well before the due date – or ensure your U.S. agent is tracking it for you.
Common mistakes to avoid
- Wrong FEI. Transposed digits or an FEI for a different location. Verify against FDA’s assignment email.
- Outdated SPL version. Always use the latest version available in the portal.
- Agent email typos. If the agent’s email is wrong, renewal reminders and FDA correspondence go nowhere.
- Confusing registration with listing. Registering the facility does not list your products. File product listings separately.
- Waiting until the last minute. Start early. Between the FEI request, gathering information, and agent coordination, allow 3-4 weeks.
Pro tip: FDA publishes a User’s Guide to Cosmetics Direct and a Facility Registration Tutorial. Review them before your first submission – they show the exact screens you will encounter and explain each field.
New to MoCRA? Start with our complete MoCRA Compliance Guide for Cosmetic Brands (2026).
Frequently asked questions
Is Cosmetics Direct free to use?
Yes. There are no portal access fees, submission fees, or subscription charges. FDA does not charge for cosmetic facility registration or product listing.
Can I file on paper instead?
Yes – FDA accepts paper forms (including Form FDA 5066). But the agency strongly encourages electronic submission through Cosmetics Direct for speed and accuracy.
How do I know my submission was accepted?
You will receive a Submission ID as confirmation. Keep it permanently. It is your proof of filing and your reference for renewals and amendments.
What if I need to change something after submitting?
File an amendment through Cosmetics Direct. Keep registration information current between renewals – do not wait for the biennial cycle to correct errors.
US MoCRA Agent is a private service provider and is not affiliated with the FDA. Questions about Cosmetics Direct: usmocra@outlook.com – +1 909-997-0000 – pricing.
This article is for educational purposes only and is not legal advice. US MoCRA Agent is a private service provider and is not affiliated with or endorsed by the FDA. Regulatory details are based on FDA’s published guidance and are current as of September 2026; always verify requirements against FDA’s official sources before acting.
Related Guides
- What Is an FDA FEI Number? — you’ll need an FEI before you can register.
- Who Can Be Your MoCRA U.S. Agent? Requirements Explained — foreign facilities must designate an agent.
- MoCRA Biennial Renewal: Keeping Your Facility Registration Current — keep the registration current after filing.

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