What a proposed order really means, and what comes next.
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Sun exposure rarely announces itself.
It sneaks in during the morning walk and the commute to work. It builds quietly—minute by minute—while life is in motion. That’s why at AELIA, we think about sun care the way pilots think about flight planning: anticipate conditions, use clear checklists, and make protection fit real life, not perfect scenarios.
This month, that real-world lens matters. The FDA has proposed an update that could eventually expand the sunscreen filters available in the U.S.
Here’s what’s changing, what isn’t, and why AELIA's mineral-first approach stays exactly where it is.
What the FDA is proposing
The FDA issued a proposed administrative order to add bemotrizinol—a modern chemical UV filter widely used outside the U.S.—to the American over-the-counter (OTC) sunscreen monograph. If finalized, brands would be allowed to use it under specific conditions and concentration limits.
This is progress. It reflects a system slowly catching up with decades of global sunscreen innovation.
But it’s important to be clear: this is a proposal, not a final rule. The FDA has opened a public comment period and will review feedback before deciding whether to issue a final order. Until that happens, nothing on U.S. shelves changes.
Why bemotrizinol gets attention
Bemotrizinol’s full INCI name—Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine—is a mouthful. But it’s worth recognizing, because it’s widely regarded as one of the most effective sunscreen agents available today.
Bemotrizinol is known for three things formulators care deeply about:
- Balanced UVA and UVB coverage
- Strong photostability (it doesn’t break down easily in sunlight)
- The ability to help create high-SPF formulas that still feel good on skin
You won’t find it in U.S.-made sunscreens yet—not because it’s ineffective or unsafe, but because current U.S. regulations make it extremely difficult for newer sunscreen filters to gain approval. Outside the U.S., however, bemotrizinol is widely used in regions like Europe, Australia, and parts of Asia.
What makes it stand out is performance. Bemotrizinol is a true broad-spectrum chemical filter, covering the full UVB and UVA range from 280–400 nm, with peak protection around 310 nm and 345 nm. Unlike older UV filters, it is highly photostable—it barely degrades when exposed to sunlight.
It was designed specifically as a new-generation sunscreen agent for high SPF and strong UVA protection. In a widely cited 2007 study comparing 18 sunscreen agents approved in the EU, bemotrizinol delivered the highest standalone SPF performance. At the maximum concentration allowed under EU regulations, it achieved an SPF of 20 on its own—something very few filters can do.
From a formulation standpoint, bemotrizinol is an oil-soluble, slightly yellow powder that stays mostly on the surface of the skin rather than absorbing deeply. That’s actually good news: sunscreen agents are meant to sit where UV exposure happens.
Its safety profile is also well established. Studies show that bemotrizinol (along with its related filter, Trinosorb M) does not demonstrate estrogenic activity, which distinguishes it from some older chemical filters and contributes to its strong safety reputation.
Overall, many formulators and dermatologists consider bemotrizinol—often referred to by its trade name, Trinosorb S—one of the best sunscreen options available today.
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Mineral, chemical, or both: where AELIA stands AELIA was created for travelers, pilots, and anyone who spends long hours near windows or at altitude. From the beginning, we’ve been mineral-first by design. Mineral filters like zinc oxide sit on top of the skin and act as a sheer, physical shield. For many people—especially those with sensitive or reactive skin—this feels more predictable, easier to trust, and easier to reapply during long days. That philosophy doesn’t change with this news. Here’s how it fits:
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What changes now for shoppers
In practical terms: nothing yet.
The proposal must move through public comment and FDA review before any final decision. In the meantime, the advice stays refreshingly simple:
- Look for clear labeling. Broad spectrum always. Water resistance when needed.
- Prioritize comfort. Texture isn’t just cosmetic—it’s functional.
- Don't forget to reapply
A quick primer on UV filters
Mineral filters sit on the skin and reflect UV, acting like a light, invisible jacket once set. Chemical filters absorb UV energy and help neutralize it. Both can work well when applied correctly and reapplied on time. The best sunscreen is still the one you will use every day.
Pilots, crews, and frequent flyers: what to do next
If you spend your days flying or working outside, the basics don’t change:
- Use enough sunscreen and apply it evenly
- Give mineral formulas a brief moment to set before makeup
- Reapply on a consistent schedule
Good habits—not ingredients alone—are what keep labeled protection performing in real life.
How regulatory progress typically unfolds
Proposed order published
When the FDA publishes a proposed administrative order, it’s signaling that the agency has reviewed a body of scientific evidence and believes an ingredient may meet its safety and effectiveness standard for over-the-counter sunscreen use in the U.S.
At this stage, the FDA:
- Evaluates toxicology, absorption, and exposure data
- Reviews how the ingredient performs across UVB and UVA wavelengths
- Proposes specific conditions of use, such as: maximum allowable concentration, permitted product types (e.g., lotions, sprays), labeling or testing requirements
The proposal is not approval. It’s more like saying, “Based on the data we have, this looks promising—but we need broader input before making it official.”
Public comment and scientific review
Once published, the FDA opens a public comment period, typically lasting several weeks to months.
The agency reviews input from clinicians, manufacturers, dermatologists, medical researchers, toxicologists, and the public (advocacy groups and individual consumers)
- The FDA reviews: new or unpublished data submitted during comments, concerns about long-term exposure or specific populations, practical considerations, such as real-world use patterns
Final order
If, after reviewing all comments and data, the FDA concludes the ingredient meets its standard of being “Generally Recognized as Safe and Effective” (GRASE), the agency issues a final administrative order.
At that point:
- The sunscreen monograph is officially amended
- The ingredient becomes legally permissible for OTC sunscreens in the U.S.
- Brands may begin developing formulations that comply with the defined conditions
Even then, products don’t appear overnight. Brands must still:
- Formulate and stability-test products
- Conduct SPF and broad-spectrum testing
- Finalize packaging and labeling
- Manufacture at scale
This means that years can pass between a final FDA order and widespread availability on store shelves.
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Where AELIA stands
The U.S. sunscreen system is designed to prioritize safety and consistency—but that caution also explains why many modern filters used globally are still unavailable domestically. AELIA supports steps that make daily sun protection easier to wear and easier to trust. |
Mabel Amber / Pixabay
FAQs
What exactly did the FDA propose?
The FDA proposed adding bemotrizinol to the U.S. sunscreen monograph under defined conditions of use. It is not final yet.
When could products with bemotrizinol appear in stores?
There is no set date. The proposal goes through the public comment and FDA review before any final order.
Is bemotrizinol “better” than mineral sunscreen?
Both approaches can work well when used correctly. Mineral filters remain a steady choice for sensitive routines and high-exposure days. More approved filters give formulators more ways to create wearable protection.
Dermatologists often point out a simple truth: sunscreen only works if people actually wear it. Filters like bemotrizinol can help brands design lighter, more elegant textures—formulas that sit comfortably under makeup, feel less greasy, and fit into everyday routines.
For U.S. consumers, the headline isn’t one “better” ingredient. It’s more choice—and choice matters when comfort drives consistency.
Does this change what pilots or frequent flyers should do right now?
No. Keep using broad-spectrum SPF, apply enough, and reapply on schedule, especially by windows or at altitude.
Where does AELIA fit?
AELIA remains a mineral-first brand founded by a pilot, focused on clean, sensitive-skin friendly protection that travels well.
Sources
- Federal Register, “Amending Over-the-Counter Monograph M020: Sunscreen Drug Products for Over-the-Counter Human Use.” https://www.federalregister.gov/documents/2025/12/12/2025-22649/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use
- U.S. Food and Drug Administration, Proposed Administrative Order: Bemotrizinol, OTC000039. https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/supportDoc/OTC000039/Internal_Documents/2025.12.09%20ProposedOrder_BemotrizinolOTC000039_090026f88e15dab6.pdf
- The Washington Post, “FDA moves to expand sunscreen options.” https://www.washingtonpost.com/health/2025/12/11/new-sunscreen-ingredient-bemotrizinol-fda/
- Allure, “The FDA Finally Proposed the Approval of a New Sunscreen Filter.” https://www.allure.com/story/fda-proposes-bemotrizinol-suncreen-filter-approval
- Dermatology Times, “FDA proposes expansion of US sunscreen ingredient standards with bemotrizinol.” https://www.dermatologytimes.com/view/fda-proposes-expansion-of-us-sunscreen-ingredient-standards-with-bemotrizinol
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C&EN, “Policy Watch: FDA proposes first new sunscreen molecule since 1996.” https://cen.acs.org/policy/Dec-12-Policy-Watch-FDA/103/web/2025/12
