MoCRA Registration for Imported Korean Cosmetics

MoCRA registration has two parts: every facility that manufactures or processes cosmetics for the US market, including factories in Korea, registers with FDA, and the responsible person named on the label lists each product and its ingredients.

Both can be done through FDA’s Cosmetics Direct portal. On top of that, MoCRA requires serious adverse event reporting, safety substantiation records and a US contact on the label.

The Modernization of Cosmetics Regulation Act was signed on 29 December 2022. This guide reflects FDA material checked up to 16 October 2026 and is written for US importers and retailers of Korean skincare.

Step 1: Agree who registers and who lists

MoCRA splits duties by role:

• Facility registration: the owner or operator of a facility that manufactures or processes cosmetics for US distribution. Korean factories making products for the US are covered, and foreign facilities must name a US agent.
• Product listing: the responsible person, meaning the manufacturer, packer or distributor whose name appears on the label.

If you sell a Korean product under your own company name, you are the responsible person. If it is sold under the Korean brand’s name, the brand often takes that role. Put the split of duties in your supply contract before the first shipment.

Step 2: Check the small business exemption

According to FDA’s small business fact sheet, businesses with average annual US cosmetics sales below USD 1 million over the previous three years, adjusted for inflation, can be exempt from registration and listing.

The exemption does not apply, whatever the sales, to firms that make or process products that contact the mucous membrane of the eye, are injected, are intended for internal use, or are meant to alter appearance for more than 24 hours. Exempt firms still have adverse event, safety substantiation and labelling duties.

Step 3: Register facilities in Cosmetics Direct

FDA built Cosmetics Direct for registration and listing; paper forms and the Electronic Submissions Gateway are alternatives. Registrations are renewed every two years. FDA’s 2023 compliance policy postponed enforcement, which began on 1 July 2024.

A Korean factory that already registered for another US customer has a registration number you can use in your listings. Ask your supplier for it early.

Step 4: List each product and its ingredients

The responsible person lists every product sold in the US, with the facility that makes it and its full ingredient list, and updates listings every year. In May 2026 FDA reported more than 15,000 active facility registrations and more than 1 million active product listings (FDA Voices, 4 May 2026). For Hangul ingredient lists, see INCI names for Korean ingredients.

Step 5: Labels, adverse events and safety records

• Label contact: labels must carry a US address, phone number or electronic contact through which adverse events can be reported (required from 29 December 2024).
• Adverse events: the responsible person reports serious adverse events to FDA within 15 business days of learning of them.
• Safety substantiation: the responsible person keeps records showing the product is safe.

MoCRA also gave FDA mandatory recall authority and access to records.

Rules still to come

According to FDA, rules on cosmetics GMP, fragrance allergen labelling and talc asbestos testing have not yet been finalised. Each will affect Korean manufacturers and labels once published, so keep an eye on FDA announcements.

Sunscreens are not cosmetics in the US

Products marketed with SPF protection are over-the-counter drugs in the US and follow drug rules rather than MoCRA. Many Korean sunscreens therefore cannot simply be listed as cosmetics; see sunscreen regulation by country. For duty questions, read US tariffs on Korean cosmetics.

SEONGWOO GLOBAL supplies Korean skincare to overseas buyers from Seoul. If you import into the US, contact us through the pages below.

Related articles: Sunscreen regulation by country · US tariffs on Korean cosmetics · Cross-border ecommerce vs B2B export

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See also: Korean skincare for US buyers