Korean Sunscreen Filters Outside the US OTC Monograph
Sixteen entries in Korea’s UV-filter list are outside the US OTC sunscreen monograph. That is a comparison of regulatory lists, not a blanket ban on every US use: ecamsule has a separate, product-specific new drug application route. The table gives the Korean ingredient names and concentration limits.
Two lists, sixteen filters apart
This comparison uses Korea’s cosmetic-safety list and the US OTC sunscreen monograph. US products approved through individual new drug applications are a separate route. The permitted concentration and other conditions must be checked for the applicable route.
Korea’s list is in Annex 2 of MFDS Notice 2026-19, dated March 18, 2026, under 자외선 차단성분. It contains 32 entries. The US monograph contains 17 after the June 2026 addition of bemotrizinol.
The sixteen entries below appear in Korea’s cosmetic-safety annex but not in the US OTC sunscreen monograph. A monograph exclusion and the absence of any possible US approval route are different claims.
| Name as printed on Korean packaging | International name | Korean ceiling |
|---|---|---|
| 드로메트리졸트리실록산 | Drometrizole Trisiloxane (Mexoryl XL) | 15% |
| 드로메트리졸 | Drometrizole | 1.0% |
| 디갈로일트리올리에이트 | Digalloyl Trioleate | 5% |
| 디소듐페닐디벤즈이미다졸테트라설포네이트 | Disodium Phenyl Dibenzimidazole Tetrasulfonate (Neo Heliopan AP) | 10% |
| 디에칠헥실부타미도트리아존 | Diethylhexyl Butamido Triazone (Uvasorb HEB) | 10% |
| 디에칠아미노하이드록시벤조일헥실벤조에이트 | Diethylamino Hydroxybenzoyl Hexyl Benzoate (Uvinul A Plus) | 10% |
| 메칠렌비스-벤조트리아졸릴테트라메칠부틸페놀 | Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Tinosorb M) | 10% |
| 4-메칠벤질리덴캠퍼 | 4-Methylbenzylidene Camphor | 4% |
| 메톡시프로필아미노사이클로헥세닐리덴에톡시에틸사이아노아세테이트 | Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (Mexoryl 400) | 3% |
| 에칠디하이드록시프로필파바 | Ethyl Dihydroxypropyl PABA | 5% |
| 에칠헥실트리아존 | Ethylhexyl Triazone (Uvinul T 150) | 5% |
| 이소아밀-p-메톡시신나메이트 | Isoamyl p-Methoxycinnamate | 10% |
| 폴리실리콘-15 | Polysilicone-15 | 10% |
| 테레프탈릴리덴디캠퍼설포닉애씨드 | Terephthalylidene Dicamphor Sulfonic Acid (Mexoryl SX) | 10% |
| 트리스-바이페닐 트라이아진 | Tris-Biphenyl Triazine (Tinosorb A2B) | 10% |
| 페닐렌 비스-디페닐트리아진 | Phenylene Bis-Diphenyltriazine (TriAsorB) | 5% |
The table lists Korean ingredient names with their corresponding limits. It is not a ranking, and each ceiling is a legal maximum rather than a recommended use level.
The first column is what a Korean bottle actually prints. Korean ingredient lists are written in Korean-language INCI, so a product bought from a Korean seller shows 메칠렌비스-벤조트리아졸릴테트라메칠부틸페놀, not Tinosorb M. That is the single most useful thing on this page if you are trying to work out what is in a bottle you already own.
One filter runs the other way. Aminobenzoic acid — PABA, permitted in the US up to 15% — is not on Korea's list at all. It is also a filter almost nobody formulates with anymore. The reason the gap is otherwise one-directional has nothing to do with the molecules: Korea regulates sunscreen as a functional cosmetic and the US regulates it as an over-the-counter drug, a split laid out in how the Korean and US sunscreen rulebooks diverged.
What the missing filters actually do
The list includes filters used for UVA, UVB or broader coverage. Absorption range, photostability and the whole formula all contribute to a finished sunscreen’s performance; a filter name does not establish its texture or measured protection.
BASF’s published portfolio data lists absorption peaks at 305 and 360 nm for bisoctrizole, 354 nm for DHHB, and 314 nm for ethylhexyl triazone. These describe individual filter properties, rather than a comparative wear test of finished Korean and US products.
Bemotrizinol has a 6% ceiling in the US monograph and a 10% ceiling in Korea. Its US final order also includes an exclusivity provision; the monograph addition is not blanket authorization for every manufacturer or finished formula.
Ecamsule (Mexoryl SX) is available in specific US products approved under new drug applications. FDA’s report on sunscreen innovation identifies that exception. It does not add ecamsule to the OTC monograph or authorize every formula containing it.
The same filter, a different ceiling
Sixteen filters are shared between the two lists, and even there the numbers do not match. The ceilings were set by different agencies at different times against different safety reviews, so a formula legal in one market can be illegal in the other without changing a single ingredient.
| Filter | Korean ceiling | US ceiling |
|---|---|---|
| Homosalate (호모살레이트) | 10% | 15% |
| Sulisobenzone / Benzophenone-4 (벤조페논-4) | 5% | 10% |
| Bemotrizinol (비스에칠헥실옥시페놀메톡시페닐트리아진) | 10% | 6% |
| Oxybenzone / Benzophenone-3 (벤조페논-3) | 2.4% | 6% |
| Avobenzone (부틸메톡시디벤조일메탄) | 5% | 3% |
| Cinoxate (시녹세이트) | 5% | 3% |
Ordered by the size of the gap between the two ceilings, largest first. Korea's oxybenzone limit rises to 5% for products used on the face, hands and lips; the 2.4% figure is the general limit.
Avobenzone has different concentration ceilings in the two lists. It is not the only US-monograph ingredient with UVA1 coverage: zinc oxide and the newly added bemotrizinol also contribute there. A concentration ceiling alone cannot explain why one finished sunscreen feels heavier than another.
Korea’s list changed in 2025 and 2026
The two lists also move at completely different speeds, and 2025–2026 makes the contrast unusually clean.
MFDS added tris-biphenyl triazine in its September 2, 2025 amendment. The current March 18, 2026 text includes phenylene bis-diphenyltriazine at 5%, with a restriction on products that could expose the lungs by inhalation. The current annex is the basis for the table, rather than the older PDF linked in the original article.
FDA added bemotrizinol in June 2026. These changes occurred through different regulatory routes; two additions do not establish a universal approval speed for either country. Our US availability guide discusses the separate manufacturing and registration requirements.
Adding bemotrizinol did not add the sixteen entries in the table to the US OTC monograph.
What this changes when you read a label
If you are holding a Korean bottle, the filter list is the fastest way to tell what you actually bought.
- Use the Korean names to identify ingredients, then check the applicable US route. Ecamsule’s product-specific NDA approvals are an exception to any simple “not in the monograph means never sold in the US” rule.
- Check whether a US-labeled version exists. Several Korean brands sell a reformulated US version under the same product name. Same box, different filter list — the difference shows up in the ingredients, not the branding.
- Read the ceiling column as a maximum, not a spec. A label that lists ethylhexyl triazone tells you the filter is present, not that it is present at 5%. Korean labels do not disclose filter percentages.
- Do not read the filter list as a protection grade. What the number on the front of the bottle certifies is a separate question, and Korea and the US certify it with different tests, explained in how Korea's PA grades are measured against US broad-spectrum claims.
- https://www.mfds.go.kr/brd/m_211/view.do?seq=14956
- https://cosmorning.com/news/article.html?no=51974
- https://www.cosmorning.com/news/article.html?no=52458
- http://www.cncnews.co.kr/news/article.html?no=10647
- https://www.cosmorning.com/news/article.html?no=51465
- https://zdnet.co.kr/view/?no=20240802094934
- https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-352/subpart-B/section-352.10
- https://www.fda.gov/news-events/press-announcements/fda-expands-sunscreen-options-first-time-20-years
- https://ami-ingredients.fr/wp-content/uploads/2018/06/Filtres-UV-1.pdf
Correction, October 14, 2026: the comparison concerns the US OTC monograph. Ecamsule has product-specific NDA approvals; avobenzone is not the only monograph ingredient with UVA1 coverage. FDA sunscreen innovation report · FDA sunscreen regulatory Q&A · MFDS current cosmetic-safety annex
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