North America
Manufacturing in Korea for the United States Market
The US is the largest single destination for Korean-made skincare and the one where the rules changed most recently. MoCRA introduced obligations that did not exist a few years ago, and one product category — sunscreen — is not a cosmetic in the US at all.
The framework
- Regulator
- U.S. Food and Drug Administration (FDA)
- Governing law
- Federal Food, Drug, and Cosmetic Act, as amended by MoCRA (2022)
- Before you can sell
- No pre-market approval for cosmetics. Facility registration and product listing are required.
- Must be established locally
- A responsible person named on the label, with a US address.
- Sunscreen is
- Regulated as an over-the-counter drug, not a cosmetic.
From formula to first shipment.
- 01
Confirm the product is a cosmetic
Classification turns on intended use, not on the label. A product intended to affect the structure or function of the body is a drug. Sunscreen, anti-acne and anti-dandruff products fall outside the cosmetic route in the US even when they are ordinary cosmetics in Korea.
- 02
Establish the responsible person
MoCRA requires a responsible person whose name and US address appear on the label. This is usually the brand owner or the importer, and it is a legal role rather than a formality — safety substantiation and adverse event records sit with it.
- 03
Register the facility and list the product
Manufacturing facilities register with FDA and each product is listed, with renewal on a defined cycle. The registration obligation follows the facility; the listing obligation follows the responsible person.
- 04
Assemble safety substantiation
MoCRA requires adequate substantiation of safety on file. This is built from raw material data, formulation data and testing, and it is assembled during development rather than reconstructed afterwards.
- 05
Prepare compliant labelling
Ingredient declaration in descending order under the applicable US labelling rules, English language, net contents, and the responsible person contact for adverse event reporting.
- 06
Import and distribute
Shipping documentation, customs entry and the importer of record. Products can be detained at entry for labelling and classification issues, which is the most common reason a first shipment is delayed.
What catches brands out here.
Sunscreen is an over-the-counter drug
This is the single most consequential difference for a Korean manufacturer. A Korean SPF product cannot simply be relabelled for the US. The permitted UV filter list in the US is narrower and older than Korea’s, so many well-regarded Korean sunscreen formulas cannot be sold as sunscreen in the US at all. Plan the US version separately or plan not to sell it there.
Claims move a product into the drug category
Acne treatment, dandruff, wound healing, and anything describing a change to the body’s structure or function are drug claims. This trips up ingredient-led brands most often — clinical language inherited from a Korean clinic context does not survive translation into US marketing copy.
Colour additives are separately regulated
Certain colour additives require FDA batch certification and some are restricted by application area. A colour that is routine in Korea may not be permitted in a US eye-area product.
Talc-containing products carry a testing requirement
MoCRA introduced testing requirements for talc-containing cosmetics. If a formula includes talc, the testing obligation should be settled before production rather than after.
We document. Your local entity registers.
- Full quantitative formula and specification sheets
- Certificates of analysis by batch
- Stability and challenge test reports
- Ingredient documentation supporting safety substantiation
- Manufacturing process and facility information for registration
- Shipping and customs documentation
- The responsible person and its US address
- FDA product listing and renewal
- Final label review against US requirements
- Adverse event record keeping and reporting
- Importer of record and customs entry
Manufacturing through contracted Korean partners, matched to your product — every order made in Korea. Certifications depend on the selected manufacturing partner and project requirements.
Why this market
The US is the largest export destination for Korean cosmetics and the market where K-beauty has the deepest retail distribution, from mass channels to specialty beauty.
Ingredient-led positioning performs well: US consumers now recognise Korean formulation categories by name rather than only by country of origin.
The practical constraint is not demand but classification. Brands that plan the US version during development rather than after usually reach shelf a season earlier.
Selling in United States
Can I sell a Korean sunscreen in the United States?
Not as a straightforward relabel. Sunscreen is an over-the-counter drug in the US rather than a cosmetic, and the permitted UV filter list is narrower than Korea’s. Many Korean sunscreen formulas rely on filters that are not available for US sunscreen products, so a US version generally has to be developed separately.
Do I need FDA approval before selling a cosmetic in the US?
There is no pre-market approval for cosmetics, but that is not the same as no obligations. Under MoCRA, facilities register, products are listed, safety must be substantiated and a responsible person is named on the label. Colour additives are a separate matter and some do require certification.
Who is the responsible person — us or the manufacturer?
It is the entity whose name appears on the product label, which in practice is the brand owner or the importer, and it must have a US address. A Korean manufacturer is not the responsible person for your product. We supply the manufacturing-side documentation the responsible person needs.
What US claims should we avoid on an ingredient-led product?
Anything describing treatment of a condition or a change to the body’s structure or function — healing, regenerating, treating acne or dermatitis. There is a workable cosmetic vocabulary for every ingredient we develop with, and agreeing it before artwork is printed is much cheaper than rewriting afterwards.
Sources
- Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?) — U.S. Food and Drug Administration
- Modernization of Cosmetics Regulation Act of 2022 (MoCRA) — U.S. Food and Drug Administration
- Registration & Listing of Cosmetic Product Facilities and Products — U.S. Food and Drug Administration
- Sunscreen: How to Decode the Label — U.S. Food and Drug Administration
Requirements differ by market and by product, and they keep changing. Cross-check the current position as your project moves, and confirm it with a qualified regulatory consultant in United States before committing to a formula or a launch date. We review these pages against the sources above as the rules move.
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What’s Next in Beauty.
Tell us you are selling into United States at the brief stage rather than after. It changes the formula, not just the label.
Start Your Project →This page is general information for manufacturing planning. It is not legal or regulatory advice, it has no legal effect, and no rights can be derived from it. Requirements change by market and over time — before acting on anything here, confirm the current position with the authority concerned or with qualified counsel.