Is there a small business exemption for product listing?

Yes. Qualifying small businesses (< $1M average annual gross sales over 3 years) ARE exempt from product listing UNLESS they manufacture high-risk products (eye-contact cosmetics, injectables, internal-use products, or long-lasting appearance-altering products). Manufacturing even ONE high-risk product eliminates exemptions for ALL products.

What is the difference between product listing and facility registration?

Facility registration covers manufacturing and processing locations - where products are made. Product listing covers individual cosmetic products - what is being sold. Both are required under MoCRA, but they are separate submissions with different responsible parties.

Do I need to list every product variation (shade, size)?

Generally, each unique formulation should have its own listing. Different shades with different ingredients need separate listings. Different sizes of the same formulation may be listed together. Consult FDA guidance for specific situations.

What ingredients do I need to disclose?

You must list all ingredients in descending order of predominance using INCI names. Under MoCRA, you must also provide the individual components of any fragrance or flavor compounds. This breakdown is not made public but is required for the listing.

How do I update a product listing?

Log into Cosmetics Direct and select the product listing you need to update. Make your changes and resubmit. Updates must be made within 60 days of any product changes, including formulation changes, name changes, or manufacturing facility changes.

MoCRA Product Listing Requirements: Step-by-Step Guide

Q: What is the difference between product listing and facility registration?

Facility registration covers manufacturing and processing locations - where products are made. Product listing covers individual cosmetic products - what is being sold. Both are required under MoCRA, but they are separate submissions with different responsible parties.

Q: Do I need to list every product variation (shade, size)?

Generally, each unique formulation should have its own listing. Different shades with different ingredients need separate listings. Different sizes of the same formulation may be listed together. Consult FDA guidance for specific situations.

Q: What ingredients do I need to disclose?

You must list all ingredients in descending order of predominance using INCI names. Under MoCRA, you must also provide the individual components of any fragrance or flavor compounds. This breakdown is not made public but is required for the listing.

Q: How do I update a product listing?

Log into Cosmetics Direct and select the product listing you need to update. Make your changes and resubmit. Updates must be made within 60 days of any product changes, including formulation changes, name changes, or manufacturing facility changes.

What is MoCRA Product Listing?

Under the Modernization of Cosmetics Regulation Act (MoCRA), all cosmetic products distributed in the United States must be listed with the FDA. This is separate from facility registration and applies to the "responsible person" for each product.

Key Distinction

Product listing is different from facility registration. Facility registration covers manufacturing locations. Product listing covers individual cosmetic products. A single facility may manufacture many listed products, and a single company may list products made at multiple facilities.

According to 21 U.S.C. § 364b, product listing is mandatory for non-small businesses. Qualifying small businesses (< $1M average annual gross sales AND no high-risk products) are exempt from product listing.

Who Must List Products?

Per FDA registration and listing guidance, the "responsible person" must list products:

Product Listing Responsibility
Entity Type	Must List?	When
Brand owner (US)	Yes	When their name appears on label
Brand owner (foreign)	Yes	Must designate US Agent
Contract manufacturer	No*	Unless their name is on label
Private label retailer	Yes	For store-brand products
Distributor	Yes*	If their name appears on label
Importer	Depends	If acting as responsible person

* *The entity whose name appears on the product label is the responsible person who must list the product

Required Information for Product Listing

FDA's Cosmetics Direct portal requires the following information for each product listing:

Required Product Listing Information

Product name as it appears on the label
Brand name
Cosmetic product category (from FDA's list)
Complete ingredient list in descending order of predominance
Fragrance and flavor ingredient breakdown (if applicable)
Responsible person name and contact information
Facility registration number(s) where product is manufactured
Product label image (recommended but not required)

Ingredient Listing Requirements

Per 21 CFR Part 701, ingredients must be listed:

In descending order of predominance by weight
Using INCI (International Nomenclature of Cosmetic Ingredients) names
Including all sub-components of fragrance/flavor (new under MoCRA)

Fragrance Breakdown

Unlike pre-MoCRA requirements, you must now provide the individual components of any fragrance or flavor compounds used in your products. This information is not made public but is required for the listing.

Fragrance Allergen Disclosure Thresholds

For FDA product listing submissions (SPL format), fragrance allergens must be disclosed at these concentration thresholds:

Fragrance Allergen Disclosure Thresholds
Product Type	Threshold	Timeline
Leave-on products	≥ 0.001%	See implementation timeline below
Rinse-off products	≥ 0.01%	See implementation timeline below

Implementation Timeline:

Products introduced before August 1, 2026: 24 specific allergens at above thresholds
Products introduced after August 1, 2026: All fragrance allergens at above thresholds
Full compliance deadline: August 1, 2028

Step-by-Step Product Listing Process

How to List Your Products

Create FDA Account

If you don't have one, create an FDA Industry Systems account. This is the same account used for facility registration. Foreign companies must designate a US Agent first.

Access Cosmetics Direct

Log into the Cosmetics Direct portal at direct.fda.gov. Navigate to the Product Listing section.

Enter Product Information

Complete all required fields for each product. You can list multiple products in a single session. Have your ingredient lists and facility registration numbers ready.

Select Product Category

Choose the appropriate FDA cosmetic category from the dropdown list. Products may fit multiple categories - select the primary category.

Enter Ingredient List

Enter all ingredients in descending order of predominance. Use INCI names. For fragrances and flavors, you must provide the individual component breakdown.

Link to Facility Registration

Associate each product with the registered facility or facilities where it is manufactured. You'll need your FEI (Facility Establishment Identifier) numbers.

Review and Submit

Review all entered information for accuracy. Once submitted, you'll receive a confirmation with your product listing number.

Save Documentation

Save your confirmation and maintain records of all product listings. You'll need to update listings when products change.

Product Listing Timeline and Deadlines

Product Listing Deadlines
Scenario	Deadline	Status
Products on market before Dec 29, 2022	December 29, 2023	Passed - list immediately if not done
New products entering market	Within 120 days of first sale	Ongoing requirement
Product formulation changes	Within 60 days of change	Ongoing requirement
Product discontinuation	Update listing to show discontinued	When applicable
Annual updates	Not required (update as needed)	Ongoing

Deadline Passed

The initial deadline for listing products on the market before December 29, 2022 has passed. If your products are not yet listed, you should list them immediately to avoid potential FDA enforcement action.

When to Update Product Listings

You must update your product listing within 60 days when:

Triggers for Listing Updates

Product formulation changes (new or removed ingredients)
Ingredient concentration changes affecting order of predominance
Product name or brand name changes
Responsible person changes
Manufacturing facility changes
Product is discontinued (mark as discontinued)
Product is reintroduced after discontinuation

Product Listing vs. Facility Registration

Product Listing vs. Facility Registration
Aspect	Product Listing	Facility Registration
What it covers	Individual cosmetic products	Manufacturing/processing locations
Who submits	Responsible person (brand owner)	Facility owner/operator
Deadline for new	120 days of market entry	60 days of beginning operations
Update frequency	Within 60 days of changes	Annual renewal + 60-day updates
Small business exemption	Yes - under $1M threshold*	Yes - under $1M threshold*
Fee	No fee	No fee

Small Business Considerations

Per FDA Guidance for Industry (December 2024) and Section 612 of the FD&C Act:

Small Business Exemption

Qualifying small businesses (< $1M average annual gross sales over 3 years) ARE exempt from product listing UNLESS they manufacture high-risk products: - Eye-contact cosmetics (mascara, liquid eyeliner, eyelash adhesive) - Injectable products - Internal-use products - Long-lasting appearance-altering products (> 24 hours)

High-Risk Product Warning

Manufacturing even ONE high-risk product eliminates exemption for ALL products. If you make mascara and lip balm, you must list BOTH products.

Common Product Listing Mistakes

Common Mistakes to Avoid

Listing products under wrong responsible person
Using trade names instead of INCI names for ingredients
Not providing fragrance/flavor breakdown
Failing to link products to registered facilities
Not updating listings when formulations change
Assuming small business exemption applies when manufacturing high-risk products
Listing ingredient order incorrectly (must be by predominance)
Not listing all products (every SKU needs listing)

Small businesses (< $1M, no high-risk products) ARE exempt from product listing

High-risk product categories eliminate ALL exemptions (even for non-high-risk products)

The responsible person (name on label) must list each product

Use FDA's Cosmetics Direct portal for submissions

New products must be listed within 120 days of market entry

Update listings within 60 days of any product changes

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