Why Korean Sunscreens Are Hard to Buy in the US

US law defines a drug as, among other things, anything meant to prevent disease or to affect how the body works.⁹ Every sunscreen sold in the US must say it "helps prevent sunburn". If it passes the FDA's tests as Broad Spectrum SPF 15 or higher, it may also say it lowers the risk of skin cancer and early skin aging caused by the sun.⁸ So the FDA regulates sunscreens as over-the-counter (OTC) drugs, sold without a prescription, and checks them against safety and effectiveness standards as it does other OTC medicines.⁷

An OTC sunscreen can skip an individual drug approval only if it follows the sunscreen "monograph", the FDA's rulebook for this product type. The monograph sets the allowed active ingredients and their strengths, along with the labels and tests. A sunscreen that doesn't follow it needs its own approved new drug application (NDA).²³

The CARES Act, signed into law on March 27, 2020, made the FDA's 1999 sunscreen rules the legal baseline. Those rules list 16 active ingredients, each with a maximum strength.¹²⁶

In a 2021 proposal, which repeated its 2019 one, the FDA said only zinc oxide and titanium dioxide (both up to 25%) had the data to be "generally recognized as safe and effective". It said PABA and trolamine salicylate were not, and that the other 12 needed more data.⁶ On September 10, 2026 the FDA finalised the PABA and trolamine salicylate part, ordering both off the list because their risks in sunscreens outweigh their benefits. The FDA says it knows of no sunscreen sold in the US that contains either. It will deal with the rest of the proposal, including labels and a maximum SPF, in later orders.⁵⁶⁷

Ecamsule (Mexoryl SX) is a special case. The FDA approved it in 2006, but only inside specific sunscreens that have their own new drug application, so it isn't on the monograph list for other products to use.¹⁸

The CARES Act replaced the old rule-making process with FDA "orders". A company can ask the FDA to add an ingredient to a monograph by filing an order request.²⁶

Bemotrizinol (Tinosorb S) went through this process. DSM Nutritional Products filed its request on September 23, 2024. The FDA proposed adding it, at up to 6%, on December 12, 2025, took comments until January 26, 2026, and issued the final order unchanged on June 10, 2026. Sprays may use it only if no propellant touches the formula.³⁴ The Korea Herald reported that the new rules took effect on August 9, 2026, making bemotrizinol the first new US sunscreen active since the late 1990s.¹⁶

When an order adds a new active ingredient at a company's request, the law gives that company, plus its licensees, assignees and successors, 18 months after the order takes effect as the only ones allowed to sell products using it.² The Korea Herald reported that during that window, other firms need to buy bemotrizinol through DSM-Firmenich or get a licence.¹⁶

Korea's Cosmetics Act (화장품법) puts products that help protect skin from UV rays in a special group called functional cosmetics (기능성화장품, gineungseong hwajangpum). The group also covers whitening, anti-wrinkle and some hair products. Each functional cosmetic must have its safety and efficacy reviewed by MFDS, product by product, or be reported to it.¹³

Korea still controls the ingredients. The Act says no UV filter may be used unless MFDS has set a usage standard for it, and MFDS's safety rules repeat that only filters in their [Annex 2] are allowed.¹¹¹³ Manufacturers, distributors and research bodies can apply to have a new filter listed.¹³ MFDS added tris-biphenyl triazine on September 2, 2025 and phenylene bis-diphenyltriazine on March 18, 2026, each after a review under its ingredient-designation rules. That made 32 listed filters.¹¹¹²

All 15 actives the US will keep, plus trolamine salicylate, are on Korea's list too, though often with different limits: Korea allows less homosalate (10% against 15%) and sulisobenzone (5% against 10%), and more avobenzone (5% against 3%).¹¹¹

Two kinds of UV light matter here. SPF (sun protection factor) comes from a sunburn test, so it mainly shows protection from UVB.⁷ UVA (wavelengths of about 315 to 400 nanometres) doesn't mainly cause reddening, so SPF says little about it.¹⁷

In the US, SPF is tested on human volunteers, with at least 10 valid results. A product may say "Broad Spectrum" only if a lab test shows its protection reaches far enough into UVA (a "critical wavelength" of 370 nm or more).⁸

Korea tests SPF on at least 10 people per product, and rates UVA protection with a PA grade instead. The grade comes from how much a product delays lasting skin darkening under UVA: PA+ for a UVA protection factor of 2 to under 4, PA++ for 4 to under 8, PA+++ for 8 to under 16 and PA++++ for 16 or more. Korean labels show SPF as a whole number, and anything at 50 or above as "SPF50+".¹⁴ The FDA proposed a cap of SPF 60+ in 2019 and 2021, but that part of its proposal is still open.⁶

A Korean sunscreen made with a filter that's missing from the US list doesn't meet the monograph. Without its own drug approval, the FDA treats it as an unapproved new drug.²⁸ US law says drugs offered for import in violation of the new-drug rules "shall be refused admission".¹⁰

The Korea Herald quoted an industry official as saying the US rules force Korean brands to develop separate US-specific formulas, and that bemotrizinol's approval alone doesn't mean Korean sunscreens can be exported to the US as they are. It noted that Korean sunscreens often pair bemotrizinol with filters such as DHHB and ethylhexyl triazone, which remain off the US list. The paper also reported that the US was Korea's biggest cosmetics buyer, taking more than a fifth of its cosmetics shipments in the first half of 2026.¹⁶

Korea, September 2, 2025: MFDS notice 2025-63 added tris-biphenyl triazine as a UV filter the same day. Its other UV-filter changes took effect on March 3, 2026: a lower oxybenzone (benzophenone-3) limit, now 2.4% in most products and 5% in face, hand and lip products, and the removal of a lawsone and dihydroxyacetone mix from the UV-filter list. Products made under the old rules may be sold for up to two years after that.¹¹¹²

Korea, March 18, 2026: notice 2026-19 added phenylene bis-diphenyltriazine, at up to 5%, as the 32nd listed filter.¹¹

US, June 10, 2026: the FDA added bemotrizinol at up to 6%. The Korea Herald reported it took effect on August 9.³¹⁶

Korea, September 2, 2026: under notice 2026-56, products with more than 2.4% oxybenzone must tell users to apply them only where the directions say and not on the whole body.¹⁵

US, September 10, 2026: the FDA ordered PABA and trolamine salicylate off the list. The order can't take effect sooner than a year after it was issued.⁵⁶