xFDA is available to assist you with Rx and OTC Drug Facility Registration and Product Listing, which now includes Cosmetics.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA)

FDA Cosmetic Facility Registration and Product Listing

If you are manufacturing cosmetics for the US market you must list them with the FDA.

Most cosmetic facilities, including contract manufacturers engaged in manufacturing cosmetic products marketed in the U.S., must register with the FDA. Registered facilities must provide any updates or changes annually. Renewal of registration is every two years. A U.S. Agent is required for all facilities outside the U.S. xFDA is able to provide this service for you.

Cosmetic Product Listing

Whatever name is on a cosmetic (manufacturer, packager, or distributor) must list the cosmetic with the FDA.

Cosmetic manufacturers, packers, and distributors whose name is on the product label to submit a cosmetic product listing to the FDA. In addition, the cosmetic product listing must include a list of ingredients, including color additives, fragrances, and flavors, manufacturer facility name and location, responsible party, and a jpg image, not more than 1 mb, of all sides of the product label. Cosmetic product listings must be updated annually noting any changes made

Cosmetic Facility Registration

If you are manufacturing cosmetics for the US market, you must register the facility with the FDA

Most cosmetic facilities, including contract manufacturers engaged in manufacturing cosmetic products marketed in the U.S., must register with the FDA. Registered facilities must provide any updates or changes annually. Annual update of facility is every 2 years.

Listing and Registration Exemptions

Small businesses are exempt from cosmetic listing requirements.

Small businesses whose average gross annual U.S. sales for the past three years is less than $1,000,000 USD are exempt from some requirements such as GMP, facility registration, and product listing (optional registration will still be available for such small businesses). Certain cosmetic products, such as items that come in contact with the eye or cosmetics for internal use, injectables, and long-lasting cosmetics, are not eligible for the exemption and must comply regardless of their sales volume.

Please contact us to discuss your needs

• Cosmetic product listings and proper data submission.
• Registration of cosmetic facilities with the FDA.
• Label review to comply with the FDA cosmetic labeling requirements
• U.S. Agent services availability for cosmetic facilities located outside the U.S.