New Sunscreen Approved
United States approves new sunscreen ingredient, catching up on protection options.
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The FDA approved bemotrizinol on June 9, 2026 — the first new sunscreen ingredient cleared for the U.S. market in 27 years. FDA issued the Final Administrative Order (OTC000039), allowing the filter, sold under the brand name Parsol Shield, to be used in sunscreen lotions, creams, gels, and sticks at concentrations up to 6%.
The approval ends nearly three decades of stagnation in American sun protection. While Europe, Asia, and Australia have used bemotrizinol since 1999, U.S. consumers have been stuck with older, less stable filters. Products containing the ingredient can begin shipping as early as August 9, 2026.
Why U.S. Sunscreen Options Fell So Far Behind
The root of the problem is classification. The FDA treats sunscreen as an over-the-counter drug, not a cosmetic. That means manufacturers must run expensive clinical trials — called Maximal Usage Trials — to prove safety before approval. Those tests can cost millions of dollars and take years, according to SupplySide Supplement Journal.
DSM Nutritional Products first applied to the FDA for bemotrizinol back in 2005. The company spent an estimated $20 million over two decades to win approval, running trials on 500 participants to show the ingredient does not absorb significantly into the bloodstream. Its large molecular weight — 627.8 grams per mole — is key. The molecule is simply too big to pass through skin, according to AJMC.
Bemotrizinol Fixes a Real Gap in UVA Protection
Most U.S. chemical sunscreens rely on avobenzone to block UVA rays — the kind linked to skin aging and deeper tissue damage. The problem: avobenzone breaks down in sunlight. Bemotrizinol is photostable, meaning it does not degrade. It protects against both UVA and UVB rays without losing effectiveness, according to EWG.
David Andrews, Ph.D., of the Environmental Working Group called it "a win that has been a long time coming," saying the approval "will help close the UVA protection gap." Dermatologist Dr. Rachel Nazarian told CBS News the ingredient is a "game-changer" because it stays on the skin's surface without causing irritation. Because it leaves no white cast, experts expect it to boost sunscreen use among people of color, who often find mineral filters cosmetically unappealing.
How the CARES Act and MAHA Finally Broke the Logjam
Two policy shifts made the approval possible. First, the 2020 CARES Act replaced the FDA's slow rulemaking process with a faster "Administrative Order" system. Then HHS Secretary Robert F. Kennedy Jr. pushed the approval as part of his "Make America Healthy Again" strategy. Kennedy said the action "will increase competition and consumer confidence," per the FDA news release.
Acting FDA drug center director Dr. Mike Davis said the approval shows "exactly the kind of progress we can achieve when we modernize our processes and apply sound science." Congressman Bob Latta, a sponsor of the 2025 OMUFA Act, added: "For too long, the FDA's approval process prevented new sunscreen ingredients that are widely used around the world from becoming available in the United States," according to ELLE.
What Consumers Can Expect — and What's Still Off Limits
Kenvue, the parent company of Neutrogena and Aveeno, has already confirmed plans to launch bemotrizinol-based products, according to AJMC. Manufacturer dsm-firmenich holds an 18-month exclusivity period starting August 9, 2026, making it the sole U.S. supplier until early 2028. Expect lotions, gels, and sticks first.
One catch: the FDA rejected bemotrizinol for aerosol sprays and powders. There is not enough data yet on what happens when the ingredient is inhaled. The agency also stopped short of officially endorsing the "reef-safe" label, even though bemotrizinol is widely seen as less harmful to coral reefs than older filters like oxybenzone, per Venable LLP.
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