Why Aren't Korean Sunscreens FDA Approved?
US law classifies sunscreen as a drug, so Korean filters like Tinosorb M and Uvinul A Plus are not allowed. What the 2026 bemotrizinol order changed.
Korean sunscreens are not “FDA approved” because the United States regulates sunscreen as an over-the-counter drug, and a sunscreen can only be sold here if every active ingredient is on FDA’s short monograph list. Most Korean formulas depend on modern filters such as Uvinul A Plus, Tinosorb M and ethylhexyl triazone that have never been added to that list. In Korea, the EU and most other markets, sunscreen is a cosmetic or functional cosmetic with a much longer filter menu.
One thing changed in 2026: FDA added bemotrizinol, sold as Tinosorb S, to the US list. We checked the Federal Register notices and FDA’s final order on October 6, 2026. The order was announced on June 10, 2026 and took effect on August 9, 2026, but it covers one filter, comes with an 18-month exclusivity period for the requesting company and its licensees, and does not make any existing Korean formula legal to sell as a US sunscreen.
Sunscreen is a drug in the US and a cosmetic almost everywhere else
The difference starts with a definition. In its June 2026 final order, FDA spells it out: under the Federal Food, Drug, and Cosmetic Act, a drug is an article intended to prevent disease, and sunscreens are intended to help prevent sunburn and, for broad-spectrum SPF 15 and higher products used with other sun protection, to decrease the risk of skin cancer and early skin aging. FDA states that this makes sunscreens drugs under US law, “in contrast to other countries, where sunscreens are regulated as cosmetics.”
Being a drug means a sunscreen must either go through a full new drug application, which almost no sunscreen does, or conform to the OTC monograph: a rulebook that lists permitted active ingredients and their maximum concentrations, allowed combinations, labeling, and SPF and broad-spectrum test methods. Before August 2026 that list held 16 filters. Of those, avobenzone is the only one that offers strong long-wave UVA coverage among the organic filters, with zinc oxide covering UVA among the minerals.
Korea regulates sunscreen as a functional cosmetic: the Ministry of Food and Drug Safety (MFDS) lists permitted UV filters and their limits, and SPF and PA claims must be supported by testing. The EU lists permitted filters in Annex VI of its Cosmetics Regulation. Neither system requires a drug-style monograph proceeding for each filter, which helps explain why both markets adopted newer filters through the 1990s and 2000s while the US list stayed frozen.
Why the US list stayed frozen for decades
Filter makers did try. FDA’s May 2020 report to Congress under the Sunscreen Innovation Act lists eight filters that applied for monograph status through “time and extent applications” between 2002 and 2009, including bemotrizinol (application dated April 11, 2005), bisoctrizole, drometrizole trisiloxane, octyl triazone, diethylhexyl butamido triazone, amiloxate, ecamsule and enzacamene. FDA responded in 2014 and 2015 that the available safety and effectiveness data were not sufficient. As of that 2020 report, every one of the eight was listed as “pending data submission,” and for several the report notes no contact from the sponsor for years.
The bar rose for the old filters too. In its February 2019 proposed rule, FDA proposed that only zinc oxide and titanium dioxide were generally recognized as safe and effective, that PABA and trolamine salicylate were not, and that the remaining 12 ingredients, including avobenzone, needed more data. A central request was a maximal usage trial, which measures how much of an ingredient reaches the bloodstream under heavy use.
FDA’s own researchers showed why. In a randomized trial of 48 healthy adults, sunscreen was applied at 2 mg per square centimeter to 75% of the body once on day 1 and four times a day on days 2 to 4 (Matta et al., JAMA, 2020). All six tested filters (avobenzone, oxybenzone, octocrylene, homosalate, octisalate and octinoxate) exceeded FDA’s 0.5 ng/mL threshold in blood after a single application. Crossing that threshold triggers a requirement for further safety data under FDA’s framework; it is not itself a finding of harm. It did make clear that any new filter would need the same kind of human absorption data. Under the old process, a supplier that paid for those studies got no protection once the filter was listed, because any manufacturer could then use it. The 2020 reform added an incentive: a successful requestor receives 18 months of marketing exclusivity, which is the window DSM now holds for bemotrizinol.
Bemotrizinol: what the 2025 and 2026 orders actually say
The opening came through a newer route created in 2020 by the CARES Act: an OTC monograph order request. DSM Nutritional Products submitted one on September 23, 2024. These are the dates and conditions, checked against the Federal Register and FDA’s final order on October 6, 2026:
| Step | Date | What it said |
|---|---|---|
| Order request filed | September 23, 2024 | DSM Nutritional Products asked FDA to add bemotrizinol to Monograph M020 |
| Proposed order OTC000039 | Federal Register notice December 12, 2025 | Add bemotrizinol at concentrations up to 6 percent; comments due January 26, 2026 |
| Final order OTC000039 | Issued and announced in the Federal Register June 10, 2026 | FDA received about 50 comments and made no changes to the proposal |
| Effective date | August 9, 2026 | Stated in Section VI of the final order, unless the order is disputed |
| Exclusivity | 18 months after the effective date | Only DSM and its licensees, assignees or successors may market products under the order during this window |
The final order sets conditions a bemotrizinol sunscreen must meet:
- Concentration: up to and including 6 percent, with the finished product reaching at least SPF 2 from bemotrizinol.
- Combinations: it can be combined with other monograph filters, but not with PABA or trolamine salicylate.
- Dosage forms: oil, lotion, cream, gel, butter, paste, ointment, stick and spray, but sprays must be pump sprays or bag-on-valve systems where the propellant never touches the formula. Traditional aerosol sprays and powders are not covered.
- Who can use it: FDA found adequate safety evidence for adults and children 6 months and older, noting that the submitted data showed bemotrizinol “is not readily absorbed through human skin, even with repeat application.”
What the order does not do matters just as much. It does not add Tinosorb M, Uvinul A Plus or any other filter. It does not change labeling rules, so a US bemotrizinol sunscreen will still say “Broad Spectrum SPF” rather than carry a PA grade. And FDA notes that its separate 2021 proposal to overhaul the whole monograph (proposed order OTC000008) is still not finalized; if it is, bemotrizinol products will have to meet those new conditions too.
US vs Korea vs EU: which filters are allowed
The table compares status, not maximum concentrations, which differ by market. US status is from Monograph M020 as amended by the June 2026 final order, and “pending data” reflects FDA’s May 2020 report to Congress. Coverage describes each filter’s general absorption profile.
| Filter (INCI name / trade name) | Main coverage | United States | South Korea | European Union |
|---|---|---|---|---|
| Bis-ethylhexyloxyphenol methoxyphenyl triazine / Tinosorb S (bemotrizinol) | UVB and UVA | Allowed up to 6% from August 9, 2026; 18-month exclusivity | Allowed | Allowed |
| Methylene bis-benzotriazolyl tetramethylbutylphenol / Tinosorb M (bisoctrizole) | UVB and UVA | Not allowed; application pending data | Allowed | Allowed |
| Diethylamino hydroxybenzoyl hexyl benzoate / Uvinul A Plus | Long-wave UVA | Not allowed | Allowed | Allowed |
| Ethylhexyl triazone / Uvinul T 150 (octyl triazone) | UVB | Not allowed; application pending data | Allowed | Allowed |
| Diethylhexyl butamido triazone / Uvasorb HEB | UVB | Not allowed; application pending data | Allowed | Allowed |
| Drometrizole trisiloxane / Mexoryl XL | UVB and UVA | Not allowed; application pending data | Allowed | Allowed |
| Terephthalylidene dicamphor sulfonic acid / Mexoryl SX (ecamsule) | UVA | Only in specific products approved through new drug applications (four as of 2020) | Allowed | Allowed |
| Butyl methoxydibenzoylmethane (avobenzone) | Long-wave UVA | Allowed up to 3% | Allowed | Allowed |
| Homosalate | UVB | Allowed up to 15% | Allowed | Allowed |
| Zinc oxide | UVB and UVA | Allowed up to 25% | Allowed | Allowed |
| Titanium dioxide | UVB and short-wave UVA | Allowed up to 25% | Allowed | Allowed |
The pattern is the point. The filters that give many Korean sunscreens their light texture and strong UVA numbers at modest concentrations are triazines and benzotriazoles that the US has not added. A US formulator who wants strong UVA coverage still leans mainly on avobenzone, which needs stabilizing, or zinc oxide, which can leave a white cast.
Broad spectrum, PA++++ and the EU UVA rule are different tests
A US “Broad Spectrum” label means the product passed one in vitro test: its critical wavelength, the point by which it has absorbed 90% of its total UV absorbance from 290 to 400 nm, must be 370 nm or higher. That shows the protection reaches into UVA. It does not say how much UVA protection there is relative to the SPF.
PA grades, used in Korea and Japan, come from a different measurement: an in vivo UVA protection factor based on persistent pigment darkening, the ISO 24442 method, which a 2026 study describes as the gold standard for UVA measurement. PA++++ is the top grade and indicates a high measured UVA protection factor, 16 or more under the grading system.
The EU recommends a third approach: the UVA protection factor should be at least one third of the labeled SPF. That ratio is where US products tend to fall short:
| Claim | Best evidence | Study type, size, duration | Strength |
|---|---|---|---|
| Most US broad-spectrum sunscreens pass the US test, but many fail the EU UVA ratio | Wang et al., JAAD, 2017 | In vitro testing of 20 US products, SPF 15 to 100+: 19 of 20 met the US critical wavelength rule; 11 of 20 met the EU ratio. Two authors worked for filter makers DSM and BASF | Limited |
| US products deliver less UVA protection than their SPF suggests | Andrews et al., 2022 | In vitro ISO 24443 testing of 51 US broad-spectrum products, SPF 15 to 110; average UVA protection factor was 24% of labeled SPF. Authors from the Environmental Working Group | Limited |
| Even high-SPF products worldwide vary widely in UVA protection | Young et al., 2026 | In vivo ISO 24442 testing of 38 SPF 50 and 50+ products from Europe, Latin America, Oceania and Asia; UVA-PF ranged from 3.6 to 46.6 and 26 of 38 met the EU ratio. Funded by La Roche-Posay | Limited |
| Sunscreen filters reach the bloodstream under maximal use | Matta et al., JAMA, 2020 | Randomized trial, 48 adults, 4 days of application, 21 days of blood sampling | Moderate |
The takeaway is not that Korean sunscreens are automatically better. Young and colleagues found failures among European products too, and a PA grade is only as good as the test behind it. It is that the US label gives you less information about UVA, and the US filter list makes high UVA protection harder to build.
Why ROUND LAB sells a different sunscreen in the US
ROUND LAB’s birch sunscreen is a clear example of what happens when a Korean brand enters the US market. The Korean Birch Juice Moisturizing Sunscreen is labeled SPF50+ PA++++, and its published ingredient panel lists four organic filters: diethylamino hydroxybenzoyl hexyl benzoate, ethylhexyl triazone, methylene bis-benzotriazolyl tetramethylbutylphenol and diethylhexyl butamido triazone. None of the four is in the US monograph, so that formula cannot carry a US Drug Facts box.
The US product, Birch Juice Moisturizing UVLOCK SPF 45, is a separate formula. Ulta’s listing, checked October 6, 2026, names avobenzone, homosalate and octisalate as the active ingredients, at US$17.49 on sale from US$24.99 for 1.69 oz. The SPF number changes because the US product is a different filter system, tested and labeled under US rules. Our formula analysis of the Korean tube covers the Korean version’s texture and reviewer reports.
Expect more of this. Even with bemotrizinol now listed, a Korean brand that wants to sell legally in the US has to rebuild its formula around monograph filters, run US SPF and broad-spectrum testing, and comply with US drug manufacturing and labeling rules. During the exclusivity window, bemotrizinol itself is only available through DSM or its licensees.
Is it legal or safe to buy Korean sunscreen online?
Legally, imported Korean sunscreens sit in a gray zone for buyers. FDA’s personal importation page, updated August 18, 2025, says that “in most circumstances, it is illegal for individuals to import drugs or devices into the U.S. for personal use” when the products have not been approved by FDA. FDA says it may use enforcement discretion when a product is not for a serious condition and has no known significant health risk, or when it treats a serious condition with no domestic alternative; this is discretion, not permission. FDA can refuse shipments that are on an import alert, look commercial, or appear to present a health risk.
In practice, the enforcement target is shipments and sellers, not people wearing sunscreen. Korean-formula sunscreens are widely sold through US marketplaces and import shops. The real risks for buyers are practical:
- Counterfeit and gray-market stock. Third-party listings can ship counterfeit, old or poorly stored tubes. Buy from the brand’s official store or an authorized retailer.
- No US testing. A Korean-label product was tested to Korean methods. Its SPF and PA results can be sound, but they are not interchangeable with a US Broad Spectrum SPF result.
- Labels you cannot read. Expiry dates, warnings and water-resistance claims may be in Korean only.
- Different filters, different reactions. Filters new to you can still irritate. Patch-test a new formula on a small area for a few days.
Safety-wise, the absence of a filter from the US list mostly reflects missing US paperwork and absorption data rather than a finding that the filter is unsafe; Korea and the EU review and limit these filters under their own rules. If you have a history of sunscreen allergy or a photosensitivity condition, a board-certified dermatologist can help choose filters.
A quick decision checklist
- Want a fully US-regulated product? Buy a sunscreen with a Drug Facts box and “Broad Spectrum SPF 30” or higher. For more UVA, favor zinc oxide or avobenzone-based formulas, and watch for bemotrizinol products from DSM licensees during the exclusivity window.
- Want a specific Korean formula? Confirm whether the US listing is the Korean formula or a US remake by checking the filter list, not the product name.
- Comparing UVA? Read a PA grade as a UVA measure and a US Broad Spectrum label as a pass/fail floor. They are not equivalent.
- Buying an import? Use an authorized seller, check the expiry date, and keep the full dose; label numbers assume about 2 mg per square centimeter.
If your sunscreen balls up under makeup after switching formulas, the cause is usually texture and layering rather than the filters themselves; see Why Does My Sunscreen Pill?
Related reading
- ROUND LAB Birch Juice Moisturizing Sunscreen formula analysis covers the Korean SPF50+ PA++++ tube.
- Why Does My Sunscreen Pill? explains film formers, layering and the 528-person pilling study.
Sources and research notes
The Federal Register notices for FDA's bemotrizinol proposed order (December 12, 2025) and final order (June 10, 2026), FDA's full final order OTC000039 and amended Monograph M020, FDA's 2020 Sunscreen Innovation Act report to Congress, FDA's personal importation guidance, the Danish EPA survey of EU-permitted UV filters, peer-reviewed studies on UVA protection and filter absorption, and the Ulta listing for ROUND LAB's US UVLOCK SPF 45, checked on the date shown.
Source record date: 2026-10-06. Prices and availability are as of that date.
- Federal Register 2026-11578: Final order OTC000039 adding bemotrizinol to OTC Monograph M020 (June 10, 2026)
- Federal Register 2025-22649: Proposed order OTC000039, bemotrizinol up to 6 percent (December 12, 2025)
- FDA Final Administrative Order OTC000039 (effective date, exclusivity, conditions, M020 filter list)
- FDA report to Congress under the Sunscreen Innovation Act (May 22, 2020)
- FDA: Personal importation (updated 2025-08-18)
- Danish EPA: Survey and health assessment of UV filters (2015)
- Matta et al. Effect of sunscreen application on plasma concentration of sunscreen active ingredients. JAMA 2020 (n=48 RCT)
- Wang et al. Comparison of UVA protection standards in the US and EU. J Am Acad Dermatol 2017 (20 products)
- Andrews et al. Laboratory testing of sunscreens on the US market. Photodermatol Photoimmunol Photomed 2022 (51 products)
- Young et al. In vivo UVA-PF (ISO 24442) across 38 SPF 50 and 50+ sunscreens. Photodermatol Photoimmunol Photomed 2026
- Ulta: ROUND LAB Birch Juice Moisturizing UVLOCK SPF 45 (actives and price)
- Korea MFDS, Regulation on Review of Functional Cosmetics, Annex 4 (permitted UV filters and limits)
Frequently asked questions
Why aren't Korean sunscreens FDA approved?
In the US, sunscreen is an over-the-counter drug and must either win a full new drug approval or use only the active ingredients listed in FDA's sunscreen monograph, M020. Most Korean sunscreens rely on filters such as Uvinul A Plus, Tinosorb M or ethylhexyl triazone that are not on that list, so the Korean formula cannot be sold as a US sunscreen.
Is bemotrizinol (Tinosorb S) allowed in the US now?
Yes. FDA's final order OTC000039, announced in the Federal Register on June 10, 2026, added bemotrizinol at up to 6 percent to the monograph, effective August 9, 2026. The order gives the requestor, DSM Nutritional Products, and its licensees 18 months of marketing exclusivity, so wide availability will take time.
Is PA++++ the same as broad spectrum?
No. Broad spectrum in the US means the sunscreen's critical wavelength is 370 nm or higher, a measure of how far its absorbance reaches into UVA. PA grades come from an in vivo test of UVA protection factor based on persistent pigment darkening, and PA++++ indicates a high measured UVA protection factor.
Is it illegal to buy Korean sunscreen online?
FDA says that in most circumstances it is illegal for individuals to import drugs for personal use, and US law classifies sunscreens as drugs. Enforcement focuses on shipments, which FDA can refuse, rather than on individual buyers. The practical risks for buyers are counterfeit or old stock and products that were never tested to US SPF methods.
Why does ROUND LAB sell an SPF 45 in the US and SPF 50+ in Korea?
They are different formulas. The Korean tube uses four filters not on the US list, while the US UVLOCK SPF 45 lists avobenzone, homosalate and octisalate as its Drug Facts actives. The US version had to be rebuilt from monograph filters and tested to US SPF methods.