Regulated goods
Exporting K-beauty to the US: MoCRA registration, listing and shipping
Korean skincare and makeup ship to the US in volume, and since the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) the US Food and Drug Administration expects more from the companies behind them. This guide explains who has to register what, what else MoCRA requires, and what to check before a shipment leaves Korea.
Not regulatory advice. FDA is still issuing rules under MoCRA. Check the FDA MoCRA page for the current requirements, and confirm product-specific questions with a US regulatory specialist.
MoCRA in brief
MoCRA was signed into law on December 29, 2022. It gave FDA new authority over cosmetics, including mandatory facility registration and product listing. FDA states that registration and listing requirements took effect on December 18, 2023, but FDA did not enforce them until July 1, 2024.
Who has to do what
| Obligation | Who | How and when |
|---|---|---|
| Facility registration | The owner or operator of each facility that manufactures or processes cosmetics for US distribution, including facilities in Korea | Form FDA 5066, renewed every two years. A foreign facility must name a US agent. |
| Product listing | The responsible person | Form FDA 5067, listing each marketed product with its ingredients, updated annually |
| Serious adverse event reports | The responsible person | To FDA within 15 business days of receiving the report |
| Safety substantiation | The responsible person | Keep records supporting that the product is safe |
| Label contact information | The responsible person | A US domestic address, phone number or electronic contact through which adverse events can be reported |
The responsible person
The responsible person is the manufacturer, packer or distributor whose name appears on the product label. It does not have to be located in the US. For a Korean brand selling under its own name, that is usually the brand owner. For a US importer that relabels products under its own name, it may be the importer. Agree in writing who holds this role before the first shipment: listing, adverse event reports and safety records all follow from it.
Cosmetics Direct and certificates
Registration and listing are submitted electronically, mainly through FDA's Cosmetics Direct portal, using Structured Product Labeling (SPL). FDA states that it does not provide certificates or other documents to verify registration or listing. A service that sells an "FDA certificate" for a cosmetic is selling something FDA does not issue.
Small business exemption
MoCRA exempts certain small businesses from registration and listing. The exemption does not cover products that regularly come into contact with the mucous membrane of the eye, injected products, products intended for internal use, and products intended to alter appearance for more than 24 hours. Check the thresholds on FDA's site before relying on it.
Is it a cosmetic or a drug?
US classification depends on the product's intended use and claims, not on how it is sold in Korea. Several product types that Korea treats as functional cosmetics are drugs in the US, most visibly sunscreens with an SPF claim. Those are over-the-counter drugs and follow drug rules, including drug establishment registration and the applicable OTC monograph, in addition to or instead of the cosmetic rules. Claims such as treating acne or changing skin structure can also make a product a drug. Review the claims on the label, the website and marketplace listings before shipping.
Ingredients and labeling
- Color additives used in cosmetics must be approved by FDA for that use, and some require batch certification.
- Prohibited and restricted ingredients in the US differ from Korea's lists. Check each formula against US requirements, not the Korean approval.
- English labeling with the required statements, ingredient declaration and net quantity, plus the MoCRA domestic contact information.
- Pending rules: MoCRA directed FDA to issue good manufacturing practice regulations and fragrance allergen labeling rules. Check the status of both on FDA's MoCRA page.
At the US border
Cosmetics are FDA-regulated at import. The entry data the customs broker files in CBP's system is shared with FDA, which can review it, examine the shipment and detain products that appear not to comply. FDA's prior notice requirement applies to food, not cosmetics, so do not confuse the two. A product that is held may need relabeling, reconditioning or export.
Duties apply as for any other import. The KORUS certification of origin can support a preferential rate on qualifying goods, but additional US tariffs may still apply, so check the current position before pricing.
Small parcels after de minimis
Many K-beauty brands sold directly to US consumers through low-value parcels that used to enter duty-free. That exemption has been suspended for all countries since August 29, 2025. Parcels now need a formal or informal entry with duties paid, and FDA-regulated products are part of that data. See US de minimis after 2025.
Working with a US importer or marketplace
US importers, distributors and online marketplaces often ask Korean brands for evidence before they accept products: the facility's FDA Establishment Identifier, confirmation that each product is listed, ingredient lists, English label artwork and safety documentation. Because FDA issues no certificate, the evidence is your own submission records. Keep them organized by product and facility, update them when a formula or label changes, and agree with the importer who answers FDA if a shipment is held. Clear division of these tasks in the distribution contract saves time when a question arrives.
Pre-shipment checklist
- Decide and document who is the responsible person for each product.
- Confirm each manufacturing facility is registered, with a US agent named for Korean sites.
- Confirm each product is listed, with its current ingredients.
- Check whether any product is an OTC drug in the US, such as an SPF sunscreen.
- Review formulas for color additives and US ingredient restrictions.
- Check English labels, including the US contact for adverse event reports.
- Make sure the commercial invoice describes the products specifically, with correct HS codes.
- Give the US importer or broker the data it needs for entry and, for ocean freight, the ISF.
The rest of the paperwork is covered in export shipping documents.
Common questions
Does a Korean manufacturer need to register with FDA?
If the facility manufactures or processes cosmetics for US distribution, yes, unless an exemption applies. Foreign facilities must also designate a US agent.
Can a Korean company be the responsible person?
Yes. The responsible person is whoever's name appears on the label as manufacturer, packer or distributor, and MoCRA does not require it to be in the US. The label still needs a US domestic contact for adverse event reports.
Will FDA give us a registration certificate?
No. FDA says it does not issue certificates for cosmetic registration or listing.
Are sunscreens covered by MoCRA?
Sunscreens with SPF claims are regulated as OTC drugs in the US and follow drug requirements. If a product is both a cosmetic and a drug, check with a regulatory specialist which rules apply.
Last reviewed 2026-09-17