Cosmetics export rules: United States

Rules to check before you export cosmetics to the United States (7), each with its official source.

Official sources checked between 2026-10-09 and 2026-11-04

Duty and FTAs: Even at the KORUS FTA 0% rate (with proof of origin), a Section 301 duty since 24 Jul 2026 makes most Korean goods 12.5% in total (higher rates stay; some exemptions). hts.usitc.gov, checked 2026-10-14

This is not legal or tax advice. Rules and rates change, so confirm with the official source and a local authority, your importer or an expert before you sell.

• Main rule for cosmetics: FDA MoCRA: facility registration and product listing; sunscreen is an OTC drug in the US (Drug Facts label, monograph-compliant UV filters). fda.gov, checked 2026-10-09
• US color additive approval and FDA batch certification: Every color additive in a cosmetic sold in the US must be approved by FDA for that use, and synthetic organic colors (the FD&C and D&C colors) must come from batches FDA has certified, with the FDA lot certification number on the color supplier's label: a Colour Index (CI) or E number, as on Korean and EU ingredient lists, does not show certification. Colors approved for externally applied cosmetics may not be used on the lips, and no color may be used around the eyes unless its regulation allows it. FDA names color additive violations as a common reason for detaining imported cosmetics, so check each color against FDA's list and ask your color supplier for the certification lot numbers before you ship. Your company does it · fda.gov, checked 2026-10-24
• US: ‘FDA registered’ is not ‘FDA approved’: FDA registration and listing are not FDA approval. FDA says cosmetic facility registration and product listing are neither an approval program nor a promotional tool, that a registration or listing number does not indicate approval, and that it issues no certificates; for medical devices it warns that ‘FDA registered’ or ‘FDA certified’ wording and look-alike certificates mislead. The FDA name and logo are not for private-sector materials without written permission. Keep these badges and the FDA logo out of ads, creator briefs, listings, packs and sales decks, and give a buyer who asks the registration number in plain text. Done with your importer · fda.gov, checked 2026-11-04
• US MoCRA: registration, listing and a US contact on the label: Under the US Modernization of Cosmetics Regulation Act, the factory that makes or processes the product registers with FDA (a foreign factory names a US agent) and renews every two years, and the responsible person, the company named on the label, lists each product with its ingredients, updates the listing every year, keeps records that substantiate safety and reports serious adverse events to FDA within 15 business days. The label must give a US address, a US phone number or an electronic contact such as a website or email through which consumers can report adverse events; FDA notes that a fax number or QR code is unlikely to serve. Businesses with under US$1 million a year in US cosmetics sales are exempt from registration and listing unless the product is used around the eyes, injected, taken internally or alters appearance for more than 24 hours. With a Korean OEM, the OEM registers its factory and the brand on the label lists the product. Done with your importer · fda.gov, checked 2026-10-24
• US sunscreen rules (OTC drug): In the US any product with an SPF claim is an OTC drug: only monograph UV filters are allowed (bemotrizinol from 9 Aug 2026, DSM-sourced only for 18 months; Tinosorb M, Uvinul A Plus and Uvinul T 150 are not), so many Korean formulas need changing. Before export: FDA drug establishment registration with a US agent, NDC listing, drug GMP, a Drug Facts label and US SPF tests. The yearly OTC facility fee is charged to whoever owns the factory (FY2027: $47,891, or $31,927 for a contract manufacturer), so with a Korean OEM it is the OEM's fee, often built into the unit price: ask. Your company does it · fda.gov, checked 2026-10-13
• US: these claims make the product a drug: In the US the claim decides the class: a product that treats acne or dandruff, stops sweating (antiperspirant), fights cavities with fluoride, restores hair growth or stops hair loss, increases or decreases melanin (whitening or lightening) or regenerates cells is a drug, or both a drug and a cosmetic. Acne, dandruff, antiperspirant and fluoride toothpaste products must follow the OTC drug monograph: only its active ingredients and strengths, a Drug Facts label, FDA drug establishment registration and listing, and drug GMP. Hair-growth and skin-lightening claims have no OTC monograph and need an approved drug application. Rewrite the US label, product pages and creator briefs with cosmetic claims ('brightens the look of skin', 'cleanses the scalp'), or plan the drug route before you quote. Done with your importer · fda.gov, checked 2026-10-24
• US hair dye caution statement and skin test: A synthetic (coal-tar) hair dye needs no FDA approval in the US only if its label carries the caution statement set in the law ('Caution - This product contains ingredients which may cause skin irritation on certain individuals and a preliminary test according to accompanying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness.') and the pack gives directions for a skin test; without them FDA can act against the product. Plant and mineral hair colors such as henna must be FDA-approved color additives, and eyelash or eyebrow tints cannot be sold to consumers: the only approved lash and brow dye, silver nitrate, is for professional use. Your company does it · fda.gov, checked 2026-10-24
• Applies to every product here: No US de minimis for direct parcels
• Applies to every product here: US country of origin marking (19 CFR 134)
• Open the checklist
• Work out the export price
• Same product, other countries: EU
• Same product, other countries: Japan
• Same product, other countries: China
• Same product, other countries: Vietnam
• Same product, other countries: Thailand
• Same product, other countries: Malaysia
• Same product, other countries: Singapore
• Same product, other countries: Philippines
• Same product, other countries: Australia
• Same product, other countries: Canada
• Same product, other countries: Brazil
• Same country, other products: Instant noodles & pasta
• Same country, other products: Sauces & seasonings
• Same country, other products: Food supplements & preparations
• Same country, other products: Spirits (incl. soju)
• Same country, other products: Toys
• Same country, other products: Furniture
• Same country, other products: Pet food & feed
• Same country, other products: Medical devices
• Sources: fda.gov, checked 2026-10-09
• Sources: fda.gov, checked 2026-10-24
• Sources: fda.gov, checked 2026-11-04
• Sources: fda.gov, checked 2026-10-24
• Sources: fda.gov, checked 2026-10-13
• Sources: fda.gov, checked 2026-10-24
• Sources: fda.gov, checked 2026-10-24
• Sources: hts.usitc.gov, checked 2026-10-14
• Sources: federalregister.gov, checked 2026-10-14

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