Selling Korean Sunscreen in the U.S.: What Bemotrizinol Changes, and What Retailers Must Check

Korean sunscreens are some of the most requested K-beauty products in American stores, and some of the hardest to stock legally. In the United States a sunscreen is an over-the-counter drug, not a cosmetic, and most formulas sold in Korea use UV filters the FDA has not allowed. In 2026 that started to change: the FDA added bemotrizinol, a filter Korean labs know well, to the U.S. sunscreen rules. This guide explains what changed, what still blocks Korean formulas, and what a retailer should check before putting any sunscreen on the shelf.

1. In the U.S., sunscreen is a drug

Korea treats sunscreen as a functional cosmetic that needs pre-market approval from the Ministry of Food and Drug Safety. The U.S. treats it as an over-the-counter drug governed by OTC Monograph M020, which lists the active ingredients that may be used, their maximum strengths, the tests a product must pass and the exact wording of the label.⁴⁵ A sunscreen that follows the monograph can be sold without an individual FDA approval; one that does not is an unapproved new drug, no matter how well it sells in Seoul.

The label rules are specific. A product tested for both UVA and UVB protection says “Broad Spectrum SPF” followed by its number; water resistance is claimed only as 40 or 80 minutes; and words such as “sunblock,” “waterproof” and “sweatproof” are not allowed.⁵ Everything sits in a Drug Facts panel with active ingredients and percentages, uses, warnings and directions.

2. The filter gap

The monograph lists 16 active ingredients, including zinc oxide and titanium dioxide up to 25%, avobenzone up to 3% and octocrylene up to 10%.⁵ Many of the lightweight Korean formulas American shoppers ask for are built on newer filters that are allowed in Korea and Europe but not in the U.S. monograph.²⁶

This is why the same brand often sells two different sunscreens: a Korean formula at home and a separate U.S. formula, or a product sold in the U.S. without any SPF claim at all.⁴

3. What bemotrizinol changes, and what it does not

The FDA proposed adding bemotrizinol in December 2025 and issued the final order on June 10, 2026, the first new sunscreen active ingredient in more than 20 years.¹⁷ It may be used at up to 6% in oils, lotions, creams, gels, sticks and certain sprays, for adults and children six months and older, and products that meet the monograph can be sold without a new drug application.¹⁷ The rule took effect on August 9, 2026, and the company that requested it, along with its licensees, has 18 months of marketing exclusivity from that date.²

It does not make existing Korean bottles legal. Korean formulas usually pair bemotrizinol with filters that remain unlisted, so brands must develop new U.S. recipes; Korean manufacturers expect a first wave of compliant products in late 2026 and wider availability in 2027 and 2028, once exclusivity ends.²⁶ One manufacturer told the Korea JoongAng Daily that the exact bottles on Korean shelves still cannot ship.⁶

4. What it takes to bring a sunscreen in legally

Because sunscreen is a drug, the paperwork is heavier than for skincare. The factory must register with the FDA as a drug establishment and follow drug manufacturing rules (current good manufacturing practice), each product must be listed with the FDA and carry a National Drug Code, and the factory pays an annual monograph facility fee, $19,188 for fiscal year 2026, or $12,792 for a contract manufacturer.³ Korean manufacturers describe six months to two years of development for a new U.S. formula.⁶ Enforcement is real: in 2023 the FDA placed a Korean OTC manufacturer on Import Alert 66-40 after an inspection found gaps in testing and quality control.⁸

5. The gray-market risk for stores

Korean sunscreens still reach U.S. shoppers through online resellers and suitcase imports. For a store, the risks go beyond compliance: products may sit in hot containers with no cold-chain record, Korean date codes can hide the expiry date, and there is no recall path if something goes wrong.⁴ Counterfeits are a growing problem too. In October 2026 Korea’s Ministry of SMEs and Startups and its intellectual property office launched a council to fight fake K-brand goods after counterfeit Beauty of Joseon products, including sunscreen with copied packaging and seal stickers, turned up on Amazon and TikTok Shop.⁹

A sunscreen checklist for retailers

1. Look for an English Drug Facts panel with active ingredients and percentages.
2. Check every active ingredient against the U.S. monograph list; bemotrizinol is allowed only up to 6%.
3. Read the claims: “Broad Spectrum SPF,” water resistance of 40 or 80 minutes, and no “sunblock,” “waterproof” or “sweatproof.”
4. Ask the supplier for the National Drug Code and look it up in the FDA’s NDC directory.
5. Ask who the U.S. importer of record is and how a recall would reach you.
6. Check that the expiration date is printed in a format your staff can read.
7. Buy from an authorized distributor, not from marketplace listings or resellers.
8. Store sunscreen away from heat in the stockroom, as you would any drug product.

For Korean brands

If you make sunscreen in Korea and want U.S. shelves, plan for a U.S. formula, a U.S.-registered drug facility with an annual FDA fee, NDC listings, U.S. SPF and broad-spectrum testing, and an English Drug Facts label. Registered monograph facilities paid $19,188 in FDA fees for fiscal 2026.³ It is real work, but stores trust a sunscreen they can look up.

How MIJU brings Korean brands to U.S. retail