MoCRA Cosmetic Product Listing Services
Professional preparation and submission support for cosmetic product listings under MoCRA — including responsible-person data, product categories, ingredient information, manufacturing-facility references, Cosmetics Direct filing, and annual updates.
Direct answer: Under MoCRA, the responsible person must list each covered marketed cosmetic product with FDA, including product ingredients, and provide updates annually. FDA Form 5067 is the cosmetic product listing form, and Cosmetics Direct is FDA's electronic submission portal. Product listing is not FDA approval or certification.
What Is MoCRA Product Listing & Who Must Comply?
Section 607(c) of the FD&C Act requires the responsible person for a covered cosmetic product to submit a cosmetic product listing to FDA. The responsible person is the manufacturer, packer, or distributor whose name appears on the product label. FDA's current Form FDA 5067 instructions require product, responsible-person, facility, and ingredient information.
Product listing is separate from cosmetic facility registration. Covered manufacturing and processing facilities register with FDA and renew their facility registration every two years, while responsible persons provide product-listing updates annually. Certain small businesses and certain drug/device products or facilities may qualify for exemptions.
- Responsible person is based on the name appearing on the cosmetic product label.
- Form FDA 5067 includes product category, product name, fragrance/flavor status, facilities, and ingredient information.
- Facility FEIs are generally identified for each manufacturing or processing facility.
- Product-listing updates are annual — the 60-day change rule belongs to facility registration.
- FDA registration/listing does not constitute approval, clearance, endorsement, or certification.
Our MoCRA Product Listing Services
End-to-end support for listing preparation, regulatory data review, submission, and annual maintenance.
Product Listing Preparation & Submission
We organize the required Form FDA 5067 information and coordinate submission through an FDA-supported filing method, including Cosmetics Direct when appropriate.
Ingredient, Category & Label Data Review
We review product names, category codes, ingredient names, fragrance/flavor status, responsible-person information, and label data used to prepare the listing.
Facility & FEI Review
We identify the manufacturing or processing facilities that must appear in the listing and review FEI information or exempt-facility name/address information when applicable.
Annual Updates, Discontinuation & Relisting
We support annual listing changes, abbreviated renewals when nothing changed, product discontinuations, and relisting when a discontinued cosmetic returns to market.
Professional Cosmetic Product Listing Support
Helping U.S. and international cosmetic companies prepare accurate product-listing information and maintain annual FDA records.
How Our MoCRA Product Listing Service Works
A four-step process from data collection through annual listing maintenance.
Collect Product Information
Provide responsible-person details, product names, categories, ingredient information, labels, and manufacturing or processing facility information.
Review Listing Data
We review the product category, label identity, facility FEIs, ingredient names, fragrance/flavor status, and regulatory classification.
Prepare & Submit
We prepare the Form FDA 5067 data and coordinate submission through an FDA-supported method such as Cosmetics Direct.
Maintain Annual Updates
We support annual content updates, abbreviated renewals, discontinuation, relisting, and other listing-maintenance needs.
Core Responsibilities Under MoCRA
Product listing is one part of the responsible person's broader cosmetic compliance duties.
List Covered Marketed Products
The responsible person submits a product listing for each covered cosmetic product marketed in the United States unless an exemption applies.
Identify the Correct Responsible Person
Use the manufacturer, packer, or distributor whose name appears on the cosmetic label as the responsible person for the listing.
Submit Required Product & Ingredient Data
Provide the product name, category, fragrance/flavor status, facilities, and ingredient information required by Form FDA 5067.
Identify Manufacturing / Processing Facilities
List each facility where the cosmetic is manufactured or processed, using FEI information when registration is required or exempt-facility name/address information when allowed.
Provide Annual Listing Updates
Submit annual updates for listing changes or discontinuation, or use an abbreviated renewal when no listing content has changed.
Report Serious Adverse Events Separately
Responsible persons have a separate MoCRA duty to report serious adverse events associated with U.S. cosmetic use to FDA within 15 business days.
Maintain Safety Substantiation
Keep records supporting adequate substantiation of safety for the cosmetic product; product listing does not replace this separate MoCRA duty.
Keep Facility Registration Current
Covered manufacturing or processing facilities renew their registrations every two years and update facility registration information within 60 days of changes.
MoCRA Product Listing vs. MoCRA Facility Registration
The two requirements are related, but they apply to different parties and follow different update cycles.
| Criteria | MoCRA Product Listing | MoCRA Facility Registration |
|---|---|---|
| Responsible Party | Responsible person whose name appears on the product label | Owner or operator of the manufacturing or processing facility |
| What It Covers | Covered marketed cosmetic products | Covered cosmetic manufacturing or processing facilities |
| FDA Form / Submission | Form FDA 5067 / Cosmetics Direct or other supported submission method | Form FDA 5066 / Cosmetics Direct or other supported submission method |
| Core Identifier | Product listing information and listing number when assigned | FEI used as the required facility registration number |
| Update Cycle | Updates provided annually; abbreviated renewal available when unchanged | Registration renewed every two years; registration changes updated within 60 days |
| U.S. Agent | Not a blanket requirement for every foreign responsible person | Required contact information for covered foreign facilities |
| FDA Approval? | No — listing is not FDA approval or certification | No — registration is not FDA approval or certification |
Key distinction: product-listing updates are annual, while facility registrations are renewed every two years and facility registration information is updated within 60 days of changes. Foreign-facility U.S. Agent information belongs to the facility-registration process.
Filing Yourself vs. Using FDA Registration Assistance
FDA's filing tools are available directly to industry. Professional support is useful when you want the product, facility, ingredient, and classification information reviewed before submission.
| Criteria | DIY Filing | FDA Registration Assistance |
|---|---|---|
| FDA Government Filing Fee | No general FDA user fee for Form FDA 5067 | No general FDA user fee; professional service fee applies |
| Portal / Submission | You prepare and submit the listing yourself | We prepare the listing data and coordinate submission |
| Regulatory Review | You are responsible for category, responsible-person, facility, ingredient, and classification accuracy | We review the listing data and flag common regulatory issues before submission |
| Documentation | You maintain your own records and confirmation information | We organize submission records and provide the completed filing information available from the submission |
| Annual Updates | You track annual updates, discontinuations, and abbreviated renewals | We can coordinate annual listing maintenance and updates |
| Professional Service Fee | $0 | $200 per product listing |
Informal Filing vs. FDA Registration Assistance
The responsible person remains accountable for the accuracy of the listing regardless of who helps prepare or submit the data.
| Criteria | Informal / Unstructured Filing | FDA Registration Assistance |
|---|---|---|
| Accountability | Responsibilities may be unclear if an unrelated person is helping prepare data | Defined professional engagement and documented scope |
| Responsible Person | Still must be the label-named manufacturer, packer, or distributor | We verify that the responsible-person information matches the regulatory definition |
| Facility Information | Risk of using the wrong facility identifier or assuming every facility has the same obligation | We review FEIs and exempt-facility information against the product-listing requirements |
| Annual Maintenance | May be overlooked after the initial submission | Annual updates, discontinuation, relisting, and renewal support available |
| Regulatory Positioning | Higher risk of treating listing as approval or using inaccurate U.S. Agent / 60-day language | Submission is positioned as registration/listing compliance, not FDA approval or certification |
| Professional Service Fee | Varies / informal | $200 per product listing |
MoCRA & Cosmetic Regulatory Terms You'll Encounter
A plain-language guide to the terminology used in cosmetic product listing and related MoCRA compliance.
Modernization of Cosmetics Regulation Act of 2022, which expanded FDA authority over cosmetics and added facility registration and product-listing requirements.
The manufacturer, packer, or distributor whose name appears on the cosmetic product label.
FDA's cosmetic product listing form. It can be used as a paper submission, while Cosmetics Direct and other SPL methods support electronic submissions.
FDA's cosmetic product facility registration form for manufacturers and processors that are required to register.
FDA's free electronic Structured Product Labeling authoring and submission portal for cosmetic facility registrations and product listings.
An FDA-assigned listing reference that can be used when updating, discontinuing, relisting, or renewing an existing cosmetic product listing.
FDA Establishment Identifier. FDA uses FEI as the required cosmetic facility registration number.
The U.S. contact required for a foreign cosmetic facility that is subject to facility registration. It is a facility-registration concept, not a blanket product-listing requirement for every foreign responsible person.
An adverse event meeting MoCRA's serious-event criteria. Responsible persons must report qualifying U.S. events to FDA within 15 business days.
Records and evidence supporting a reasonable certainty that the cosmetic product is safe under its labeled or customary conditions of use.
The annual Form FDA 5067 update process used for listing changes, discontinuation, or abbreviated renewal when no content changed.
A MoCRA exemption that may remove facility registration and product-listing duties for qualifying small businesses, subject to statutory exclusions for specified product categories.
Common MoCRA Product Listing Mistakes
These issues can create inaccurate records, unnecessary rework, or confusion about what MoCRA actually requires.
Incorrect Responsible Person
Using an entity that is not the manufacturer, packer, or distributor whose name appears on the product label can create an inaccurate listing record.
Missing or Incorrect Facility Information
A product listing generally must identify each manufacturing or processing facility. FEI information is used when the facility is registered; exempt facilities may require name/address instead.
Wrong Product Category or Product Name
The product category code and product name should match FDA's category framework and the statement of identity on the marketed label.
Incomplete Ingredient Information
Form FDA 5067 requires the cosmetic ingredient list. Annual change submissions should include the full current ingredient list, not only newly changed ingredients.
Using the 60-Day Facility Rule for Product Listings
The 60-day change rule applies to facility registration. Product listing changes are handled through the annual update framework.
Misapplying the U.S. Agent Requirement
A U.S. Agent is required for covered foreign cosmetic facilities as part of facility registration; Form FDA 5067 does not create a blanket U.S. Agent requirement for every foreign responsible person.
Treating Listing as FDA Approval or Certification
FDA explicitly states that cosmetic registration and listing are not approval programs and that FDA does not issue registration or listing certificates.
Complete MoCRA & Cosmetic Compliance Solutions
All eight related cosmetic-compliance services from the existing page remain available for clients who need facility, product, labeling, U.S. Agent, state, or maintenance support.
MoCRA Facility Registration
Register an applicable domestic or foreign cosmetic manufacturing or processing facility and coordinate biennial renewal requirements.
MoCRA Product Listing
Prepare and submit covered cosmetic product listings, ingredient information, facility references, and annual updates.
U.S. Agent Services for Cosmetic Facilities
U.S. Agent representation for foreign cosmetic facilities that are required to register under MoCRA.
Cosmetic Labeling & Ingredient Review
Review cosmetic labels, ingredient declarations, claims, warnings, and U.S. labeling requirements.
California Safe Cosmetics Act (CSCAR)
California cosmetic reporting support when products contain ingredients subject to state reporting requirements.
DUNS Number Assistance for Cosmetics
DUNS assistance when needed for business identity and related FDA workflows; DUNS is not the required cosmetic facility registration number under MoCRA.
MoCRA Listing Verification
Professional verification documentation prepared from applicable registration and listing records; not an FDA-issued certificate.
MoCRA Registration & Listing Maintenance
Support for biennial facility registration renewal and annual cosmetic product-listing updates.
Frequently Asked Questions — MoCRA Cosmetic Product Listing
Current answers on Form FDA 5067, responsible persons, annual updates, FEIs, foreign facilities, U.S. Agents, product variants, exemptions, and listing maintenance.
What is MoCRA Cosmetic Product Listing?
MoCRA requires a responsible person to submit a cosmetic product listing to FDA for each marketed cosmetic product that is subject to the requirement. The listing includes product information, ingredients, and the facilities where the product is manufactured or processed.
Who is responsible for submitting a MoCRA product listing?
The responsible person is the manufacturer, packer, or distributor whose name appears on the cosmetic product label. That responsible person is the party assigned the product-listing obligation under section 607(c) of the FD&C Act, unless an exemption applies.
What form is used for cosmetic product listing?
FDA Form 5067 is the paper cosmetic product listing form. FDA also accepts electronic product listings through Cosmetics Direct and other supported Structured Product Labeling submission methods.
What information is required for a MoCRA product listing?
Form FDA 5067 requires information including the responsible person name and phone number, product category code, product name as it appears on the label, whether the product contains fragrance or flavor, the facilities where the product is manufactured or processed, and a list of ingredients.
Does a MoCRA product listing mean FDA approved my cosmetic?
No. FDA states that cosmetic product facility registration and product listing are neither an approval program nor a promotional tool. FDA also states that it does not issue certificates for cosmetic product facility registrations or product listings.
Do foreign cosmetic brands have to submit product listings?
A foreign brand is subject to the same product-listing framework when it is the responsible person for a cosmetic product marketed in the United States and no exemption applies. The responsible person can use its actual foreign contact information; a U.S. Agent requirement applies to foreign cosmetic facilities as part of facility registration, not automatically to every foreign responsible person filing Form FDA 5067.
How often must cosmetic product listings be updated?
FDA states that the responsible person must provide updates to a cosmetic product listing annually. Form FDA 5067 includes an annual Update to Content document type and an Abbreviated Renewal option when no listing information has changed.
Do product-listing changes have to be filed within 60 days?
FDA's 60-day change rule applies to cosmetic facility registration information. Product listing updates are submitted annually under section 607(c)(5). This is an important distinction from the former wording on this page.
How do I report a product that is no longer marketed?
FDA Form 5067 includes a Discontinuation of Listing option under the annual Update to Content document type. Cosmetics Direct also supports discontinuation and relisting functionality.
Is product listing separate from cosmetic facility registration?
Yes. Facility registration and product listing are separate requirements. Facilities that manufacture or process covered cosmetics register with FDA, while the responsible person lists covered marketed cosmetic products. Facility registrations are renewed every two years; product-listing updates are provided annually.
Does a product listing need a facility registration number?
Generally, the listing must identify each facility where the cosmetic product is manufactured or processed using the facility's FDA Establishment Identifier (FEI). If a facility is exempt from registration and has no facility registration number, FDA allows facility name and address information to be provided instead.
Is an FEI required for a cosmetic product listing?
The listing identifies the FEI for each facility where the product is manufactured or processed when that facility is required to register. FDA uses the FEI as the required cosmetic facility registration number. An exempt facility without a registration number can instead be identified by name and address.
Is a DUNS number required for the responsible person on Form FDA 5067?
No. FDA lists the responsible person's DUNS number as optional information on Form FDA 5067. This differs from the facility FEI information required for the manufacturing or processing facilities identified in the listing.
Can multiple cosmetic products be included in one listing submission?
Yes. FDA states that a single listing submission may include multiple cosmetic products with identical formulations, or formulations that differ only with respect to colors, fragrances or flavors, or quantity of contents.
Do different shades, scents, or package sizes always need separate filings?
Not necessarily. FDA specifically allows a single listing submission to include products with identical formulations or formulations differing only in colors, fragrances or flavors, or quantity of contents. The exact grouping should match the information submitted and the products actually marketed.
What ingredient names should be used on Form FDA 5067?
FDA requires each ingredient to be identified by the name required under 21 CFR 701.3 or by the ingredient's common or usual name. Unique Ingredient Identifiers (UNIIs) are requested as optional additional information.
Does FDA require a label image with the product listing?
No. FDA lists front and back label images as optional additional information on Form FDA 5067. Product name and other required information still must accurately reflect the marketed cosmetic.
Does FDA require a U.S. Agent for a product listing?
Form FDA 5067 does not impose a U.S. Agent requirement on the responsible person merely because the responsible person is foreign. A foreign cosmetic manufacturing or processing facility that is required to register must provide U.S. Agent information on Form FDA 5066.
What is Cosmetics Direct?
Cosmetics Direct is FDA's electronic Structured Product Labeling authoring and submission portal for cosmetic facility registrations and product listings. It performs initial validations and submits data to FDA for internal processing.
Can product listings be submitted outside Cosmetics Direct?
Yes. FDA accepts product listings through Cosmetics Direct, ESG NextGen or supported SPL authoring tools, and Form FDA 5067 paper submissions. FDA strongly encourages electronic submissions for efficiency.
What is a responsible person under MoCRA?
The responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label in accordance with the FD&C Act or the Fair Packaging and Labeling Act.
Do professional-use cosmetics have to be listed?
Professional-use status by itself does not create a general product-listing exemption. Form FDA 5067 asks whether a cosmetic is for professional use only, and the responsible person should evaluate the normal MoCRA listing requirements and any applicable exemption.
Are free samples and promotional gifts covered by MoCRA product listing?
FDA's registration-and-listing guidance addresses product listings for free samples and gifts. Whether a particular product must be listed depends on whether it is a marketed cosmetic product subject to section 607 and whether an exemption applies, not simply on whether money changed hands.
What about soap, sunscreen, antiperspirant, or other drug/cosmetic products?
Regulatory classification matters. Products meeting FDA's narrow definition of soap are not cosmetics under the FD&C Act. Sunscreens and antiperspirants are drugs or drug/cosmetic combination products and must meet applicable drug requirements as well as any cosmetic requirements that still apply to combination products.
Does the MoCRA small-business exemption apply to product listing?
Certain small businesses are exempt from facility registration and product listing, but the exemption does not apply to specified higher-risk product categories, including certain eye-contact products, injected products, products intended for internal use, and certain products intended to alter appearance for more than 24 hours.
Can a company voluntarily list if it is exempt?
Yes. FDA welcomes voluntary registration and listing submissions from facilities or products that are not required to register or list. If a voluntary submission is made, mandatory system fields still must be completed because of technical limitations.
What happens if my formulation changes?
The responsible person should include changes in the annual Update to Content submission. FDA instructs filers submitting an annual change to include all ingredients in the cosmetic product, not only the ingredients that changed.
What happens if I change the responsible person?
The product listing should be updated so the FDA record reflects the responsible person whose name appears on the current product label. Product-listing updates are handled through the annual update process rather than a universal 60-day product-listing amendment deadline.
Does MoCRA product listing replace safety substantiation or adverse-event reporting?
No. Product listing is only one MoCRA obligation. Responsible persons also have separate duties, including maintaining adequate safety substantiation and reporting serious adverse events associated with cosmetic products in the United States to FDA within 15 business days.
How do I start a MoCRA product listing with FDA Registration Assistance?
Send us the responsible person information, product names, categories, ingredient lists, manufacturing or processing facility details and FEIs when applicable, and any current listing information. We will review the scope, prepare the submission, and coordinate the filing and annual-update process.
List Your Cosmetic Products With FDA
Send your responsible-person, product, ingredient, and facility information and our team will review the scope and coordinate your MoCRA product listings.
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