MoCRA Facility Registration: A Step-by-Step Guide for Indie Beauty Brands

The cosmetics industry changed forever in December 2022, when Congress passed the Modernization of Cosmetics Regulation Act (MoCRA). For the first time in over 80 years, the FDA gained serious authority to regulate cosmetics—and that means new requirements for every brand, including indie beauty founders operating out of a studio apartment or small lab.

If you manufacture, pack, or distribute cosmetics in the United States, MoCRA requires you to register your facility with the FDA and renew that registration every two years. Miss this step, and your products are considered misbranded and adulterated under federal law. No indie brand can afford that risk.

I have guided cosmetics companies through FDA compliance for years, and MoCRA is the most significant shift I have seen. The good news? Facility registration is straightforward if you know the steps. The bad news? Most beauty founders do not even know they need to do it.

This guide walks you through the exact MoCRA facility registration process for indie beauty brands. No legal jargon, no corporate assumptions—just the steps you need.

Want a companion worksheet? Grab the Free MoCRA Facility Registration Worksheet.

What Is MoCRA and Who Needs to Register?

MoCRA is the most comprehensive update to U.S. cosmetics law since the Food, Drug, and Cosmetic Act of 1938. It gives the FDA mandatory recall authority, requires serious adverse event reporting, mandates Good Manufacturing Practices (GMP), and—most relevant here—requires facility registration and product listing.

The official FDA MoCRA guidance is published at FDA.gov — MoCRA Overview.

You must register your facility if you:

Manufacture or process cosmetic products in the U.S.
Pack or hold cosmetic products for distribution in the U.S.
Import cosmetics into the U.S. (the foreign facility must register)

Exemptions include:

Products made exclusively for personal use (not sold)
Products made in a salon for on-site application
Certain small-scale soap makers (if the product is primarily alkali salts of fatty acids and makes no cosmetic claims)

If you are selling on Shopify, Etsy, at farmer’s markets, or in retail boutiques, you almost certainly need to register.

Step-by-Step Facility Registration Process

Step 1: Create an FDA Account

Before you can register anything, you need an account in the FDA’s system.

Go to the FDA Industry Systems portal.
Click on Cosmetics Direct Submission or navigate to the Cosmetics Registration and Listing submission system.
Create an account with a business email address—not your personal Gmail.
Verify your email and log in.

Pro tip: Use an email that multiple team members can access. If your founder leaves and takes the FDA account with them, you will have a bureaucratic headache.

Step 2: Gather Required Information

Before you start the registration form, have these details ready:

Facility name — the legal business name
Facility address — physical street address (P.O. boxes are not acceptable)
Mailing address — if different from the facility address
Facility phone number
Business registration number — EIN or DUNS, if available
Name and contact information of the U.S. agent — for foreign facilities, this is mandatory
Parent company name — if applicable
Type of operation — manufacturer, packer, or distributor
Product categories — a general list of cosmetic categories you handle

For indie brands, the most common mistake is using a home address or virtual office as the facility address. The FDA requires the actual physical location where cosmetics are manufactured, packed, or held. If you operate from a home studio, that is your facility address. If you use a co-packer, their facility must be registered (and you should confirm it is).

Step 3: Submit via the FDA Cosmetics Registration System

Once logged in:

Select Facility Registration from the dashboard.
Enter the facility information collected in Step 2.
Designate a responsible official — this is the person the FDA will contact. For indie brands, this is usually the founder or operations lead.
Review and certify that the information is accurate.
Submit the registration.

You should receive a confirmation email with a Facility Registration Number. Save this number in multiple places. You will need it for product listings, renewals, and any correspondence with the FDA.

Step 4: Renew Every Two Years

MoCRA facility registrations expire every two years. The FDA will not remind you. Set a calendar reminder for 90 days before expiration.

If your facility information changes—new address, new responsible official, ceased operations—you must update the registration within 60 days.

What Happens If You Don’t Register?

MoCRA is not optional. The FDA can:

Issue warning letters
Mandate product recalls
Impose penalties for adulterated or misbranded products
Share non-compliance information with state regulators

While the FDA has stated it will focus on education during the initial rollout, enforcement is ramping up. In 2025 and 2026, expect increased inspections and warning letters, especially for brands making unsubstantiated claims or selling unregistered products.

For brands selling in both English and Spanish markets, compliance documentation becomes even more critical. My guide on Bilingual Cosmetics Labeling covers how to keep your labels compliant across languages.

MoCRA Documentation Beyond Registration

Facility registration is just the beginning. MoCRA requires several other documentation pillars:

Good Manufacturing Practices (GMP) Records

While the FDA is still finalizing GMP regulations, the draft guidance emphasizes documentation of:

Batch records — formulation, weights, processing steps
Raw material specifications and certificates of analysis
Equipment cleaning and maintenance logs
Quality control testing records
Deviation and corrective action reports

Indie brands should start documenting these practices now, even if formal GMP rules are not fully in effect. It builds good habits and prepares you for future inspections.

Safety Substantiation

MoCRA requires brands to maintain records supporting the safety of their products. You do not have to submit these to the FDA, but you must have them on file and produce them if requested.

Ingredient safety data — toxicology profiles, usage history
Finished product testing — microbiological, stability, challenge testing
Safety assessments — signed by a qualified safety assessor

Serious Adverse Event Reporting

If a consumer reports a serious adverse event (hospitalization, death, significant disfigurement), you must report it to the FDA within 15 business days. You need:

A written adverse event procedure
A log of all adverse events — serious and non-serious
Copies of reports submitted to FDA

Product Listing

In addition to facility registration, every cosmetic product must be listed with the FDA. This includes:

Product name and category
List of ingredients — in descending order of predominance
Responsible person’s contact information
FDA facility registration number for the manufacturing site

Product listings must be updated annually and whenever formulations change.

Product Listing Requirements in Detail

Product listing is where many indie brands get stuck. Here is what the FDA requires for each SKU:

Product Identity: The common or usual name (e.g., “Hydrating Facial Serum”)

Ingredient List: Every ingredient, using the nomenclature from the FDA’s Voluntary Cosmetic Registration Program (VCRP) or INCI names.

Responsible Person: The name and contact information of the U.S. distributor or manufacturer responsible for the product. This is the entity the FDA will contact with questions or recalls.

Facility Registration Number: The number assigned when the manufacturing facility registered.

If you work with a contract manufacturer or co-packer, clarify who will handle product listing. Some co-packers list products under their own facility number; others expect the brand to do it. Get this in writing.

Common MoCRA Mistakes for Indie Brands

1. Assuming “small” means “exempt.” MoCRA has no small-business exemption for facility registration. If you sell cosmetics, you register.

2. Using the wrong address. Your business mailing address and your facility address are often different. The FDA needs the physical location where products are made or stored.

3. Waiting for the FDA to reach out. MoCRA is self-reporting. The FDA will not send you a welcome packet. It is your responsibility to know the law and comply.

4. Copying big-brand labels. A label that works for L’Oréal may not work for your indie brand. Ingredient declarations, warning statements, and responsible person information must be accurate for your product and your business.

5. Ignoring the 2-year renewal. Registrations expire. Set a reminder. Lapsed registrations can disrupt retail partnerships and trigger FDA scrutiny.

Free MoCRA Facility Registration Worksheet

I have created a fillable worksheet that walks you through every field in the FDA registration system. It includes:

A pre-registration checklist
Field-by-field guidance for the FDA portal
A renewal tracking calendar
Space for your facility registration number and product listing details

Download the Free MoCRA Facility Registration Worksheet →

Let’s Get Your Beauty Brand Compliant

MoCRA compliance does not have to be overwhelming. With the right documentation and a clear process, indie beauty brands can meet FDA requirements without losing the creative spark that makes them special.

I help cosmetics founders navigate MoCRA facility registration, product listing, labeling compliance, and safety documentation—so you can focus on formulating and growing your brand.

Book a free MoCRA compliance consultation →

Nestor Soto is a bilingual compliance documentation consultant with 15+ years of experience serving B2B SaaS, defense contractors, and cosmetics brands. He helps indie beauty companies navigate MoCRA, FDA labeling, and LATAM market entry compliance. Learn more at gogosoto.com.