The US sunscreen door opened — but only to 6%
On 9 June 2026 the FDA cleared bemotrizinol (Tinosorb S), effective 9 August. It is the first new organic UV filter in 27 years. But the US cap is 6% against 10% in Korea and the EU, so a Korean formula cannot move over unchanged — and four filters are still shut out.
The FDA finalized its order on bemotrizinol (bis-ethylhexyloxyphenol methoxyphenyl triazine, sold as Tinosorb S) on 9 June 2026, effective 9 August 2026. It is the first new organic UV filter cleared in the US since 1999. The US cap is 6% w/w, against 10% in Korea, the EU and Australia, so a 10% formula cannot be shipped over as-is. The US now permits 16 UV filters; the EU allows roughly 30. Tinosorb M, Uvinul A Plus, Uvinul T150 and Mexoryl XL remain unusable in the US. Sunscreen is an OTC drug in the US, not a cosmetic, so it sits under drug rules rather than MoCRA.
A 27-year wait, and the number still differs
On 9 June 2026 the FDA finalized its order on bemotrizinol — bis-ethylhexyloxyphenol methoxyphenyl triazine, sold as Tinosorb S — with the order taking effect on 9 August 2026. It is the first organic UV filter added to the US list since 1999.
There is one number in that decision buyers tend to miss. The US permits it up to 6% w/w, while Korea, the EU and Australia allow 10%. Same ingredient, same INCI name, different ceiling.
Take a formula built at 10% and cut the filter to 6% and both SPF and UVA protection fall with it. The gap has to be closed with other filters, and those have to come from the 16 the US permits. The EU allows around 30, so the US palette is roughly half the size.
In the US, sunscreen is not a cosmetic
In Korea sunscreen is a functional cosmetic. In the US it is an over-the-counter drug, because the claims it carries — preventing sunburn, reducing skin cancer risk — are drug claims.
That means MoCRA, the subject of yesterday's piece, does not apply to sunscreen at all. Ship ten skincare SKUs and one sunscreen and that single SKU falls under a different regime: drug facility registration, drug listing, and a Drug Facts panel instead of a cosmetic ingredient declaration.
This clearance came through the OTC Monograph Order Request route created by the CARES Act of 2020. DSM Nutritional Products filed in autumn 2024 and the order landed about a year and nine months later. Other filters can travel the same road, but the applicant has to generate the safety package, which is why the queue is short rather than crowded.
Four filters are still shut out
Four filters that appear routinely in Korean formulas remain outside the US list. This table is the first thing to check when moving a formula across.
| Filter | Korea cap | United States |
|---|---|---|
| Bemotrizinol (Tinosorb S) | 10% | 6%, from 9 Aug 2026 |
| Tinosorb M (bisoctrizole) | 10% | Not permitted |
| Uvinul A Plus (DHHB) | 10% | Not permitted |
| Uvinul T150 (ethylhexyl triazone) | 5% | Not permitted |
| Mexoryl XL | 15% | Not permitted |
It helps to read the table backwards. Brands that have been carrying one formula for Korea and the EU and a second for the US now have a filter that works in both, so a single shared formula is finally on the table. Sharing it, though, means holding both versions at 6% or under — which is a decision to lower the Korean product's protection to a US ceiling.
The trade-off is concrete. Keep Korea at 10% and build a separate US formula and you protect the domestic spec but keep two production runs. Unify at 6% and you get one run but a lower number than Korean competitors print on their tubes. Smaller MOQs favour unifying; a business weighted toward domestic sales favours splitting.
You will pay for testing twice
A compliant formula is not the end of it. Monograph compliance removes the need for individual product approval, but the testing and the label have to be redone to US criteria.
| Item | US requirement |
|---|---|
| SPF | Human in vivo testing |
| Broad spectrum claim | Critical wavelength ≥ 370 nm |
| UVA ratio criterion | None |
| Stability | Finished-product stability and compatibility |
| Label | Drug Facts format |
ISO 24444, the system Korea works to, requires the UVA protection factor to reach at least one third of the SPF. The FDA does not ask for that ratio and looks at critical wavelength instead. Because the criteria differ, neither report substitutes for the other, and brands launching in both markets generally run both tests.
The way to spend less is to reorder the steps. Put both criteria on the table before the formula is locked and one round of adjustment can clear both. Finish the formula to Korean criteria first, and a short critical wavelength result in US testing sends you back to the formulation bench.
Leaving sunscreen out is also a strategy
The US became Korea's largest cosmetics export market this year, but sunscreen still needs its own arithmetic. On MFDS provisional figures published 2 October 2026, cosmetics exports to the US ran to USD 2.35 billion for January–September, up 40.6%. Almost none of that growth came from sunscreen.
So three routes are in common use: build a dedicated US formula, contract a US-based OEM, or drop the UV claim and sell the product as a tone-up or makeup base. The third route forfeits the SPF number on the label, and the price point and consumer expectation come down with it.
Olive Young's US stores carry roughly 5,000 SKUs from more than 400 brands. Before committing to the paperwork for one sunscreen listing, it is worth pricing the alternative — what a different SKU in that slot would earn. Daily demand movement by ingredient is in today's ingredient signal.
In short
- The FDA cleared bemotrizinol (Tinosorb S) on 9 June 2026, effective 9 August 2026 — the first new organic UV filter in the US in 27 years
- The US cap is 6% w/w against 10% in Korea, the EU and Australia, so a 10% formula cannot move over unchanged and the shortfall must be closed from the 16 permitted US filters
- Tinosorb M (10%), Uvinul A Plus (10%), Uvinul T150 (5%) and Mexoryl XL (15%) remain unusable in the US
- Sunscreen is an OTC drug in the US, under drug rules rather than MoCRA; monograph compliance avoids an NDA but brings in vivo SPF testing, critical wavelength ≥ 370 nm and a Drug Facts panel
- ISO 24444 requires UVA-PF ≥ one third of SPF while the FDA looks only at critical wavelength — the reports are not interchangeable, so settle both criteria before locking the formula
To see how a 6% reformulation moves unit cost, the product planner returns an estimate and a sample request by SKU.
*Sources: EWG press release, "In major win for U.S. consumers, FDA approves first new sunscreen ingredient in 25 years" (9 June 2026 — 16 filters permitted in the US against roughly 30 in the EU; minimal absorption at up to 6%). Vizorsun, "Bemotrizinol Is FDA-Approved" (2026 — order finalized 9 June 2026, effective 9 August 2026; US cap 6% w/w against 10% in the EU and Australia; OTC Monograph Order Request filed by DSM Nutritional Products in autumn 2024 under the CARES Act 2020 pathway; in vivo SPF testing, critical wavelength ≥ 370 nm, finished-product stability and Drug Facts labeling). Newspim (28 July 2026 — effective date; roughly 5,000 SKUs from 400+ brands in Olive Young US stores). Decoded Korea, "Sunscreen UV Filters: A 10-Country Comparison" (April 2026 — Korean caps for Tinosorb M 10%, Uvinul A Plus 10%, Uvinul T150 5%, Mexoryl XL 15%, none approved in the US). Eurofins, "Navigating Global Sunscreen Standards: ISO 24444 vs FDA Monographs" (UVA-PF ≥ 1/3 SPF under ISO against critical wavelength ≥ 370 nm under the FDA). Hitnews, "In the US sunscreen is an OTC drug too" (basis for the drug classification; facility registration and labeling obligations; separate US production, local OEM and tone-up repositioning as working strategies). Cosinkorea (MFDS administrative notice of 2 August 2024 adding tris-biphenyl triazine, the second addition since 2018). Export figures are MFDS provisional data published 2 October 2026. Regulatory status verified 5 October 2026 and subject to change. This is not legal advice; confirm filings and formulation with a qualified specialist.*
Questions people ask
No — the formula has to be reworked. The US cap on the newly cleared bemotrizinol is 6% w/w, while Korea, the EU and Australia allow up to 10%. Dropping from 10% to 6% lowers both SPF and UVA protection, and whatever makes up the difference has to come from the 16 filters the US permits. Sunscreen is also an OTC drug in the US, so even a monograph-compliant product needs drug facility registration, drug listing and a Drug Facts panel. One ingredient opened; the regime did not change.
Four that are common in Korean formulas. Tinosorb M (bisoctrizole, 10% in Korea), Uvinul A Plus (diethylamino hydroxybenzoyl hexyl benzoate, 10%), Uvinul T150 (ethylhexyl triazone, 5%) and Mexoryl XL (15%). Any formula built on those needs a separate US version. The flip side is that bemotrizinol now works on both sides, which for the first time makes a single shared formula plausible.
Yes. Stay inside the permitted filters, their caps and the required label format and the product sells without individual approval. What remains is in vivo SPF testing, a critical wavelength of at least 370 nm for a broad spectrum claim, finished-product stability and compatibility testing, and full Drug Facts labeling. Step outside the permitted list or over a cap and the product becomes an NDA case.
Not directly. Korea works to ISO 24444, which requires the UVA protection factor to be at least one third of the SPF. The FDA asks only for critical wavelength at or above 370 nm and sets no such ratio. Both are human in vivo tests, but the acceptance criteria differ, so brands launching in both markets usually run both. Deciding this before the formula is locked is far cheaper than discovering it afterwards.
Slowly. The MFDS gave administrative notice on 2 August 2024 that it would add tris-biphenyl triazine as a new UV filter — only the second addition since 2018, after methoxypropylamino cyclohexenylidene ethoxyethyl cyanoacetate in November 2023. Filter lists move slowly everywhere, so designing inside what is already permitted is the practical route.