FDA Sunscreen UV Filter Tracker: What’s Approved, What’s Pending, and What’s Next

Last updated: July 17, 2026 — this page is reviewed and refreshed every time the FDA takes public action on a sunscreen filter. Bookmark it or check back rather than re-Googling each ingredient name.

Why I built this tracker

For nearly 25 years, the United States did not approve a single new sunscreen active ingredient, even as dermatologists and formulators watched Europe, Asia, and Australia gain access to newer, more elegant, more photostable UV filters. That changed in June 2026, when the FDA finalized an order adding bemotrizinol to the OTC sunscreen monograph — the first new filter approved since the late 1990s. But bemotrizinol was only one of eight ingredients that have been sitting in the FDA's Time and Extent Application (TEA) pipeline under the 2014 Sunscreen Innovation Act. Patients and journalists keep asking me the same question: "what's next?" This page is my answer, and I'll keep it current as the FDA moves on the rest of the list.

Current status at a glance

UV filter	Also known as	UVA/UVB coverage	FDA TEA milestone	Current status (as of last update)
Bemotrizinol	BEMT, Tinosorb S	Broad spectrum (UVB + UVA); dual absorption peaks at ~310 nm and ~340 nm	Feedback letter Nov 13, 2014; proposed order Dec 2025 (Federal Register notice Dec 12, 2025); final order issued June 10, 2026	Approved. Up to 6% concentration, ages 6 months+; effective date Aug 9, 2026.
Bisoctrizole	Tinosorb M	Broad spectrum (~280–400 nm); dual peaks at ~305 nm and ~360 nm; also scatters/reflects UV (hybrid organic-particulate filter)	FDA feedback letter Sept 3, 2014	Pending — industry asked to close safety/effectiveness data gaps; no proposed order yet.
Drometrizole trisiloxane	Mexoryl XL	Broad spectrum; dual peaks at 303 nm (UVB) and 344 nm (UVA)	FDA feedback letter Aug 29, 2014	Pending — data gap status; no proposed order yet.
Octyl triazone	Ethylhexyl triazone, Uvinul T 150	UVB; absorption maximum at 314 nm	FDA feedback letter June 23, 2014	Pending — data gap status; no proposed order yet.
Amiloxate	Isoamyl p-methoxycinnamate, Neo Heliopan E1000	UVB; peak absorption at ~308 nm	FDA feedback letter Feb 25, 2014	Pending — data gap status; no proposed order yet.
Diethylhexyl butamido triazone	Iscotrizinol, Uvasorb HEB	UVB + some UVA2; peak at ~310 nm	FDA feedback letter Feb 21, 2014	Pending — data gap status; no proposed order yet.
Ecamsule	Terephthalylidene dicamphor sulfonic acid, Mexoryl SX	UVA (mainly UVA2/short UVA); peak at 345 nm, protective range ~290–400 nm	Proposed order Feb 24, 2015	Stalled — FDA's 2015 proposed order tentatively found the data insufficient to support GRASE and asked the sponsor for more safety data; unresolved since. (Ecamsule is separately available in the U.S. only in specific L'Oréal NDA-approved formulations.)
Enzacamene	4-MBC	UVB; peak absorption at ~300 nm	Proposed order Feb 24, 2015	Stalled — FDA's 2015 proposed order tentatively found the data insufficient to support GRASE and asked the sponsor for more safety data; unresolved since.

Status of all eight Sunscreen Innovation Act TEA filters, compiled from the FDA's SIA regulatory tracking page and the December 2025 / June 2026 Federal Register actions on bemotrizinol. UV absorption peaks drawn from published filter spectroscopy data (UVB ≈ 290–320 nm; UVA2 ≈ 320–340 nm; UVA1 ≈ 340–400 nm). Full sources at the bottom of this page.

Bemotrizinol — approved (the one that broke the 25-year logjam)

The FDA announced its proposed order on December 11, 2025 (Federal Register notice December 12), and issued the final administrative order (OTC000039) on June 10, 2026 — roughly seven months later, using the expedited process created by the 2020 CARES Act. The final order permits bemotrizinol at concentrations up to 6% in broad-spectrum sunscreen products for adults and children 6 months and older, across oils, lotions, creams, and sprays; it may be combined with any other monograph sunscreen active except PABA or trolamine salicylate. The order takes effect August 9, 2026, after which manufacturers can begin reformulating and launching U.S. products that contain it. Bemotrizinol has been used safely in Europe, Asia, and elsewhere for decades and offers broad-spectrum, photostable UVA/UVB protection that many formulators and dermatologists have wanted access to for years.

The other seven filters — where they actually stand

Each of the remaining seven TEA filters received an FDA "data gap" feedback letter or proposed order back in 2014–2015, asking manufacturers to submit additional safety and effectiveness data (largely dermal absorption and long-term safety studies) before the FDA would move to a final GRASE (generally recognized as safe and effective) determination. As of this update, none of the seven has advanced to a favorable proposed or final order. Industry groups and dermatology organizations have continued to push for FDA action, and commentators covering bemotrizinol's approval have noted that the U.S. still lags well behind the EU, Japan, and Australia, where more than a dozen additional filters are already approved. There is no confirmed public timeline yet for when the FDA will act on bisoctrizole, drometrizole trisiloxane, octyl triazone, amiloxate, diethylhexyl butamido triazone (iscotrizinol), ecamsule, or enzacamene — this page will be updated the moment any of them receives a proposed or final order.

Frequently asked questions

When will I be able to buy a sunscreen with bemotrizinol in it?

The final order takes effect August 9, 2026. Manufacturers still need to reformulate and bring products through their own testing and launch timelines, so expect bemotrizinol-containing sunscreens to reach U.S. shelves gradually over the following months.

Why has it taken so long for the U.S. to approve new sunscreen filters?

Sunscreens are regulated as over-the-counter drugs in the U.S., not cosmetics, which means new filters must go through a GRASE safety and effectiveness review rather than the lighter-touch cosmetic ingredient process used in the EU and elsewhere. The 2014 Sunscreen Innovation Act was meant to speed this up for eight backlogged filters, but most have remained stuck in data-gap status for over a decade.

Is iscotrizinol the same as diethylhexyl butamido triazone?

Yes — iscotrizinol (marketed as Uvasorb HEB) is the common name for diethylhexyl butamido triazone, one of the eight ingredients in the FDA's TEA pipeline.

How often is this page updated?

I review and update this tracker whenever the FDA publishes a new proposed order, final order, or other public action on any of these eight filters — typically checked monthly at minimum.

Sources

- FDA — FDA Expands Sunscreen Options for the First Time in 20 Years (June 9, 2026)

- FDA — FDA Proposes Expanding Sunscreen Active Ingredient List (Dec 11, 2025)

- FDA — Regulatory Policy Information: Sunscreen Innovation Act

- Federal Register — Final order notice, Amending OTC Monograph M020 (June 10, 2026)

- Federal Register — Proposed order notice, Amending OTC Monograph M020 (Dec 12, 2025)

- Venable LLP — FDA Clears the Way for Bemotrizinol

- Holland & Knight — FDA Proposes First New Sunscreen Ingredient in Decades

- NPR — 4 things to know about the new sunscreen ingredient the FDA approved

- Beauty Independent — The US May Finally Get A New Sunscreen Filter. Here's What It Could Mean.

- EWG — In major win for U.S. consumers, FDA approves first new sunscreen ingredient in 25 years

Have a correction or a tip about FDA movement on one of these filters? Email me — I want this to stay the most accurate tracker on the topic.

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