Exporting Skincare Products to the United States: MoCRA, Labeling, and Ingredient Restrictions

Skincare products represent one of the fastest-growing segments of cosmetic imports into the United States, driven by consumer demand for K-beauty, J-beauty, European luxury skincare, and specialty formulations from around the world. But foreign skincare brands consistently underestimate the regulatory differences between the US market and their home markets. The United States does not pre-approve cosmetic products — there is no equivalent of the CPNP notification that grants market access in the EU. Instead, the US framework relies on facility registration and product listing under MoCRA, compliance with specific labeling requirements that differ from every other major market, and adherence to ingredient restrictions that are both narrower and broader than those in other jurisdictions.

MoCRA facility registration and product listing for skincare

Every foreign facility that manufactures or processes skincare products for distribution in the United States must register with the FDA under MoCRA. The registration must be completed through FDA's Cosmetics Direct portal and requires the facility's legal name, address, an FDA Establishment Identifier (FEI), and the designation of a US Agent. In addition to facility registration, the responsible person — typically the brand owner or the entity whose name appears on the product label — must list each skincare product with the FDA. The product listing includes the product name, category, ingredient list, and responsible person contact information. Product listings must be submitted within 120 days of marketing and must be updated annually or within 60 days of any significant change.

Labeling requirements unique to the US market

US cosmetic labeling requirements under 21 CFR Part 701 differ from EU requirements in several important ways. The ingredient list must appear in descending order of predominance using INCI (International Nomenclature of Cosmetic Ingredients) names — similar to the EU, but with some differences in naming conventions for certain ingredients. Ingredients present at concentrations of 1 percent or less may be listed in any order after those above 1 percent. Color additives must be listed separately and may use a 'may contain' statement for product lines that share a base formula across multiple shades. The net contents must appear in both US customary and metric units — a requirement that EU labels, which use only metric, must be modified to include.

The product identity statement on the principal display panel must accurately describe the product. Warning statements are required for products that have not been adequately tested for safety — under 21 CFR 740.10, the label must read 'Warning: The safety of this product has not been determined' — and for specific product types such as aerosol sprays, products containing certain ingredients, and products for use in the eye area. The name and address of the manufacturer, packer, or distributor must appear on the label, and if the entity named is not the manufacturer, a qualifying phrase ('manufactured for,' 'distributed by') is required.

Ingredient restrictions for the US market

The US and EU take fundamentally different approaches to cosmetic ingredient regulation. The EU operates through a positive list system (Annexes III through VI of Regulation 1223/2009) that specifies which substances may be used as colorants, preservatives, and UV filters, plus a negative list (Annex II) of over 1,700 prohibited substances. The US approach is more permissive in some areas — there is no positive list for preservatives, and the list of explicitly prohibited substances under 21 CFR Part 700 is much shorter than the EU's Annex II. However, the US is more restrictive in other areas — color additives must be from FDA-approved and (for certain colors) batch-certified sources, and several colorants commonly used in Asian and European skincare are not authorized for use in the US.

Specific ingredient concerns for foreign skincare brands include hydroquinone (which is regulated as an OTC drug active ingredient in the US, not as a cosmetic ingredient), retinol and retinoid derivatives (which are cosmetic ingredients in the US unless drug claims are made), certain sunscreen actives (which are regulated as OTC drugs under the sunscreen monograph, not as cosmetic ingredients), and mercury compounds, which are prohibited in cosmetics under 21 CFR 700.13 except as a preservative in eye-area cosmetics at concentrations not exceeding 65 ppm.

SPF products are drugs in the United States

One of the most consequential differences for foreign skincare brands is that any product with an SPF claim is regulated as an OTC drug in the United States — not as a cosmetic. This includes moisturizers with SPF, BB creams, CC creams, tinted sunscreens, and any skincare product that claims to protect against UV radiation. In the EU, sunscreens are cosmetics; in the US, they are drugs that must comply with the OTC drug monograph for sunscreen active ingredients (21 CFR Part 352, currently under FDA review), must be registered as drug establishments, must obtain NDC labeler codes, and must carry a Drug Facts panel instead of — or in addition to — cosmetic labeling. A foreign skincare brand that sells a moisturizer with SPF 30 in the EU as a cosmetic must register as a drug establishment in the US and comply with all applicable drug regulations.

How FDABridge helps skincare brands enter the US market

FDABridge provides MoCRA facility registration, product listing, and compliance guidance for foreign skincare brands. We help identify which of your products require cosmetic registration, which may require drug registration, and where your formulations or labels need modification for the US market. Visit fdabridge.com/cosmetics for our cosmetics services, fdabridge.com/drug for drug registration services, or fdabridge.com/contact to discuss your skincare product portfolio.