How to Register Cosmetics Under MoCRA: Step-by-Step Guide

Do I Need to Register Under MoCRA?

The Modernization of Cosmetics Regulation Act (MoCRA) requires most cosmetics companies selling products in the United States to register their facilities and list their products with FDA. But not everyone is covered. Before starting the registration process, determine whether MoCRA applies to you.

Who Must Register

MoCRA facility registration is required for any entity that manufactures or processes cosmetic products for distribution in the US. This includes:

• Domestic manufacturers with their own facilities
• Foreign manufacturers exporting cosmetics to the US
• Contract manufacturers producing cosmetics for other brands
• Companies that repack or relabel cosmetic products

Small Business Exemption (Expired)

MoCRA previously provided limited exemptions for businesses with average gross annual sales of cosmetic products below $1 million. These exemptions expired in December 2025. All cosmetics companies must now comply with facility registration and product listing requirements regardless of size.

What Is NOT a Cosmetic Under MoCRA?

Certain products are excluded from MoCRA cosmetic registration:

• True soap: Products consisting primarily of alkali salts of fatty acids used for cleansing are regulated by the Consumer Product Safety Commission, not FDA
• Drugs: Products with drug claims (e.g., anti-acne, sunscreen, antiperspirant) are regulated as drugs or drug-cosmetic combinations under separate FDA rules
• Products used exclusively by professionals in a salon or clinic setting (certain exemptions apply)

What Information Do I Need Before Registering?

Gather the following information before starting your MoCRA registration. Having everything prepared will make the process significantly faster.

DUNS Number

A DUNS (Data Universal Numbering System) number is a unique nine-digit identifier issued by Dun & Bradstreet. FDA requires a DUNS number for cosmetic facility registration. If you do not have one, you can request it for free at dnb.com. Allow 1-2 weeks for processing.

How Do I Create an FDA Account?

Before you can register a facility or list products, you need an FDA Industry Systems account. This account gives you access to the FDA Unified Registration and Listing System (FURLS) and the Cosmetics Direct portal.

Step-by-Step: Creating Your FDA Account

1. Go to the FDA Industry Systems page at access.fda.gov
2. Click "Create Account" and select "Industry" as the account type
3. Complete identity verification -- you will need to provide your name, organization, and email address
4. Set up multi-factor authentication (MFA) -- FDA now requires MFA for all industry accounts
5. Wait for account activation -- this typically takes 1-3 business days. You will receive an email confirmation when your account is active

How Do I Register My Facility?

Once your FDA account is active, you can register your manufacturing facilities through the Cosmetics Direct portal. Each facility where cosmetics are manufactured, processed, or packed must be registered separately.

Step-by-Step: Facility Registration in FURLS

1. Log in to FDA Industry Systems at access.fda.gov
2. Navigate to Cosmetics Direct from the FDA Industry Systems dashboard
3. Select "Facility Registration" and click "Add New Facility"
4. Enter your DUNS number -- the system will auto-populate your facility name and address from the DUNS database
5. Verify and complete facility details:
   • Confirm or correct the facility name and address
   • Add the owner/operator information
   • Specify operations performed (manufacturing, packing, relabeling)
   • Select the cosmetic product categories made at this facility
6. Add contact person information -- name, phone, and email for the person FDA should contact about this facility
7. Review and submit -- double-check all information before submitting. There is no registration fee
8. Save your confirmation -- you will receive an FDA registration number for the facility. Store this securely

How Do I Submit Product Listings?

After registering your facility, you must list every cosmetic product you market in the United States. Product listing is done through the same Cosmetics Direct portal using the Cosmetic Product Listing (CPL) process.

Step-by-Step: Cosmetic Product Listing

1. Navigate to "Product Listing" in Cosmetics Direct
2. Click "Add New Product" to begin a new listing
3. Enter product details:
   • Product name (as it appears on the label)
   • Product category from FDA's predefined list (e.g., skin care, hair care, makeup)
   • Subcategory if applicable
4. Add the complete ingredient list -- enter each ingredient using its INCI (International Nomenclature of Cosmetic Ingredients) name. List ingredients in descending order of predominance
5. Associate the manufacturing facility -- link the product to the registered facility where it is manufactured
6. Enter Responsible Person information -- the name and contact details of the person or entity responsible for the product
7. Review and submit -- verify all data is accurate before submitting

Products That Must Be Listed

• Every SKU sold or distributed in the US
• Private label products (listed by the Responsible Person)
• Products imported from foreign manufacturers
• Professional-use products distributed commercially

What Is a Responsible Person and Do I Need One?

MoCRA introduces the concept of the "Responsible Person" -- the individual or entity legally accountable for a cosmetic product's compliance with FDA requirements. Understanding this role is critical for both domestic and foreign companies.

Who Is the Responsible Person?

• Domestic companies: The manufacturer, packer, or distributor whose name appears on the product label is the Responsible Person
• Foreign companies: The US importer becomes the Responsible Person for products manufactured outside the United States
• Private label brands: The brand owner whose name appears on the label is typically the Responsible Person, not the contract manufacturer

Responsible Person Obligations

The Responsible Person is accountable for:

• Submitting and maintaining product listings
• Reporting serious adverse events to FDA within 15 business days
• Ensuring adequate safety substantiation exists for each product
• Maintaining required records for a minimum of 6 years
• Including contact information on product labels for adverse event reporting

Foreign Companies and US Agents

Foreign facility owners must designate a US Agent -- a person or entity located in the United States who serves as FDA's point of contact. The US Agent is not the same as the Responsible Person, but both roles may be filled by the same entity (such as a US importer or a compliance service like Assurentry).

How Do I Set Up Adverse Event Reporting?

One of MoCRA's most important requirements is mandatory reporting of serious adverse events (SAEs). Unlike facility registration, there is no small business exemption for adverse event reporting -- every cosmetics company must comply regardless of revenue.

What Must Be Reported?

A serious adverse event is any health-related event associated with the use of a cosmetic product that results in:

• Death or life-threatening experience
• Inpatient hospitalization
• Persistent or significant disability or incapacity
• Congenital anomaly or birth defect
• Significant disfigurement, including serious and persistent rash, second- or third-degree burns, significant hair loss, or persistent skin discoloration
• Medical or surgical intervention to prevent one of the above outcomes

How to Report

1. Submit via CAERS -- use FDA's CFSAN Adverse Event Reporting System to file reports electronically
2. Include required information: product identification, contact information for the reporter, a description of the adverse event, and any available medical records
3. Maintain records -- keep records of all adverse events (including non-serious events) for a minimum of 6 years

Setting Up Your Internal Process

To comply with the 15-business-day reporting window, you need a reliable internal process:

• Designate a staff member or team responsible for receiving and triaging consumer complaints
• Create a standard intake form to capture event details consistently
• Establish an escalation protocol for events that may qualify as serious
• Set up calendar reminders for the 15-day and 1-year follow-up deadlines
• Ensure your product labels include a phone number or electronic contact for consumers to report adverse events

What About Safety Substantiation?

MoCRA requires that every cosmetic product marketed in the US have "adequate substantiation of safety." This means you must have reasonable evidence that your product is safe under its intended and reasonably foreseeable conditions of use.

What Counts as Adequate Substantiation?

FDA has not specified a rigid formula. Adequate substantiation can include any combination of:

• Toxicological assessments of individual ingredients and the finished product
• Published scientific literature supporting ingredient safety at the concentrations used
• Historical use data demonstrating a long history of safe use
• Clinical testing such as patch tests, repeat insult patch tests (RIPT), or human repeat insult tests
• Stability testing confirming the product remains safe throughout its shelf life
• Microbiological testing including preservative efficacy testing (PET) and challenge testing

Record Keeping

You do not submit safety data to FDA during registration, but you must maintain safety substantiation records and make them available for FDA inspection upon request. Store records securely and keep them for at least 6 years.

What Happens After Registration?

Registering your facility and listing your products is not a one-time event. MoCRA imposes ongoing compliance obligations that you must manage continuously.

Biennial Renewal

Cosmetic facility registrations must be renewed every two years during the FDA-designated renewal window. The first cosmetics biennial renewal is expected in July 2026. Missing the renewal window means your registration lapses, which can trigger FDA scrutiny and disrupt your supply chain.

Ongoing Product Listing Maintenance

Update your product listings within 60 days whenever:

• You launch a new product
• You discontinue an existing product
• You reformulate a product (ingredient changes)
• You change the product's manufacturing facility
• There is a change in the Responsible Person

Labeling Requirements

Ensure all product labels comply with MoCRA's updated requirements:

• Contact information: A phone number or electronic contact must appear on the label for adverse event reporting
• Fragrance allergen disclosure (proposed rule): FDA NPRM anticipated ~May 2026. Once finalized, specific fragrance allergens must be declared on labels. Not yet a compliance requirement.
• Standard labeling elements: Product identity, net contents, ingredient list in descending order of predominance, and required warnings

How Can Assurentry Simplify MoCRA Registration?

MoCRA registration is free to file, but it is not simple. Between DUNS numbers, FURLS accounts, product listings, and ongoing compliance, there are many places where mistakes can cause delays or enforcement risk. Assurentry handles the entire process for you.

What Assurentry Does for You

Transparent Pricing

Assurentry's MoCRA registration service starts at $249/year -- a flat, published rate that covers facility registration, product listing, and ongoing compliance support. No hidden fees, no per-product surcharges.