MoCRA Product Listing: How to List Cosmetics With FDA in Cosmetics Direct

FDA COMPLIANCE · COSMETICS (MoCRA)

Updated November 2026. Beauty and personal care brands selling on Amazon, TikTok Shop, Walmart and Shopify are now asked about MoCRA more often than ever, by marketplaces and by retail buyers. Product listing is the piece that touches every SKU. This guide covers who lists, what FDA asks for, how Cosmetics Direct works, when to update, and how to avoid the mistakes that slow brands down. It is general information, not legal advice.

What is MoCRA cosmetic product listing?

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added two filing duties for cosmetics: facility registration and product listing. FDA’s summary is direct: a responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually. Facility registration is a separate filing made by the owner or operator of each facility that manufactures or processes cosmetics, renewed every two years.

The two filings are linked. A product listing names the facilities where the product is made, using each facility’s FDA Establishment Identifier (FEI). If you are unsure which role your company plays, our answer on whether a cosmetic responsible person is the same as a U.S. Agent separates the roles.

Who has to list cosmetic products?

The responsible person. FDA defines this as the manufacturer, packer or distributor of a cosmetic product whose name appears on the label. For most private label and DTC beauty brands, that is the brand itself, because the brand’s name is on the package, even if a contract manufacturer makes the product.

Small businesses can be exempt. MoCRA exempts certain small businesses, generally those whose average gross annual U.S. sales of cosmetic products over the previous three years were under $1 million, adjusted for inflation. The exemption does not apply to responsible persons for products that:

• regularly come into contact with the mucus membrane of the eye under normal use,
• are injected,
• are intended for internal use, or
• are intended to alter appearance for more than 24 hours, where removal by the consumer is not part of normal use.

Products that are also drugs, such as sunscreens or anti-dandruff shampoos, follow drug registration and listing rules instead. Our FDA compliance services page lists both paths.

What information goes into a cosmetic product listing?

FDA’s paper form for product listing, Form FDA 5067, shows the required fields, and Cosmetics Direct asks for the same information. Required items include:

• the responsible person’s name, as shown on the label, and contact phone number;
• the product name, as shown on the label;
• the cosmetic product category code or codes;
• whether the product contains fragrance, flavor or both;
• the FEI number of each facility where the product is manufactured or processed, or the facility name and address if that facility is exempt from registration; and
• a list of ingredients, including any fragrances, flavors or colors.

FDA also requests optional information, such as images of the front and back labels, a product web page link, the responsible person’s DUNS number and whether the product is for professional use only.

One listing can cover multiple products when the formulations are identical, or differ only in colors, fragrances, flavors or quantity of contents. That matters for brands with many shades or sizes.

How does Cosmetics Direct work?

Cosmetics Direct is FDA’s electronic portal for cosmetic facility registration and product listing. FDA describes it as a Structured Product Labeling (SPL) authoring tool: you complete data entry forms, the tool runs initial validations, creates the SPL file and submits it to FDA, without using the separate Electronic Submissions Gateway. A typical first listing looks like this:

1. Create an FDA Direct account for the responsible person, or use the account of an authorized agent.
2. Confirm the FEI numbers of each manufacturing facility. FEIs can be searched in FDA’s FEI portal, and a facility without one can request one.
3. Build the ingredient list from the final formula and match it to the label.
4. Choose the product category codes and enter the product details.
5. Validate and submit. FDA assigns a product listing number once the submission is accepted.
6. Store the submission record and listing number with the product file.

In February 2026 FDA added Registration Status and Renewal Date fields to the facility registration homepage in Cosmetics Direct, and automated reminder emails go to the facility contact, the account contact and the U.S. Agent before a registration renewal is due.

When must a cosmetic product listing be submitted and updated?

• New products: within 120 days of first marketing the product in interstate commerce, for products first marketed after December 29, 2022.
• Annual updates: the responsible person must provide any updates to the listing annually, including when a product is discontinued.
• No changes: FDA provides an abbreviated renewal, where you certify that nothing in the listing has changed.
• Ingredient changes: when you update a listing for a change, FDA asks that you include all ingredients, not just the changed ones.

A reformulation is the most common trigger brands miss. If the manufacturer swaps an ingredient, the listing and the label both need to change.

Does FDA issue a product listing certificate?

No. FDA says it does not provide certificates, verification letters or emails for cosmetic facility registration or product listing, and does not confirm exemptions in writing. It also says listing is neither a cosmetic review program nor a promotional tool, and a product listing number does not mean FDA has endorsed the product. If a marketplace asks for “FDA certification,” our guide on what to send Amazon and TikTok Shop when no certificate exists covers what to provide instead.

Common product listing mistakes

• Listing under the wrong company. The responsible person must match the name on the label.
• Ingredient lists that do not match the label or the current formula.
• Missing FEI numbers because the contract manufacturer never registered its facility.
• Forgetting the annual update, including discontinued products.
• Putting a listing number in ads as if it were a seal of approval.
• Listing a drug as a cosmetic. Claims decide the category. A cream that claims to treat acne is a drug.

What Eva Commerce charges for MoCRA product listing

Eva Commerce’s MoCRA product listing service is $100 per product, one-time. Updates to the listing are included at no charge as long as it is the same product. A new or reformulated product is a new listing. MoCRA facility registration is $440, renewed every two years, and U.S. Agent service for foreign facilities is $250 per year. All prices are on our FDA compliance services page, and the full program overview is in our FDA registration and U.S. Agent guide.

Because Eva also manages Amazon, TikTok Shop, Walmart and Shopify channels, we keep the product name, ingredient list and label consistent with your marketplace listings. Book a call or call 858-315-2020 to review your SKUs.

Frequently asked questions

Who must submit a MoCRA cosmetic product listing?

The responsible person, which is the manufacturer, packer or distributor whose name appears on the cosmetic product’s label.

How long do I have to list a new cosmetic product?

For a product first marketed after December 29, 2022, the listing is due within 120 days of marketing it in interstate commerce.

How often must a cosmetic product listing be updated?

The responsible person must provide any updates annually. If nothing has changed, FDA offers an abbreviated renewal that certifies no changes.

Can one listing cover several shades or sizes?

Yes, when the formulations are identical or differ only in colors, fragrances, flavors or quantity of contents.

Are small cosmetic businesses exempt from product listing?

Certain small businesses are exempt, but not for products used near the eye, injected, used internally, or that alter appearance for more than 24 hours.

How much does Eva charge for MoCRA product listing?

$100 per product, one-time. Updates are included at no charge for the same product. A new or reformulated product is a new listing.

Sources: FDA, Registration and Listing of Cosmetic Product Facilities and Products; FDA, Cosmetics Direct; FDA, Form FDA 5067 Cosmetic Product Listing; FDA, Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products; FDA, MoCRA overview. General information, not legal advice.

Related Eva guides: FDA compliance services, Responsible person vs U.S. Agent, FDA registration certificate for marketplaces.