FDA Approves First New Sunscreen Ingredient For U.S. In 25 Years
On Tuesday, June 9, 2026, the Food and Drug Administration added the sunscreen ingredient bemotrizinol to its list of permitted over-the-counter sunscreen filters for use in the United States.[1]
FDA guidance says sunscreens containing bemotrizinol are considered generally recognized as safe and effective for adults and for children 6 months and older.[1] The agency said bemotrizinol may be used at concentrations up to 6%.[1] DSM Nutritional Products will market the ingredient in the U.S. as Parsol Shield, expects product launches later in 2026 and will have an 18-month exclusivity period before other manufacturers can use it.[1] FDA Commissioner Marty Makary said the agency has historically moved too slowly on sunscreen approvals and is working to modernize OTC regulation.[1] Karen Murry of FDA's Office of Nonprescription Drugs called bemotrizinol a welcome addition and said the agency looks forward to working with other companies on additional ingredients.[1]
Congress added Section 505G to the Federal Food, Drug, and Cosmetic Act as part of the CARES Act on March 27, 2020, creating a faster administrative pathway for new OTC active ingredients. DSM Nutritional Products submitted the first Tier 1 administrative request under those rules on September 23, 2024; the FDA filed the company's request on December 4, 2024. The agency issued a proposed administrative order finding bemotrizinol generally recognized as safe and effective on December 11, 2025. DSM-Firmenich says it spent at least $18 million over more than two decades to secure FDA approval.[2]
Bemotrizinol has been available in European sunscreens for years, a point many reporters highlighted as the U.S. move begins to close a regulatory gap.[3] Safety testing showed no reproductive harm in animals and no skin irritation in repeated human exposures, according to reporting on the studies.[2] Dermatologists say bemotrizinol is broadly photostable and gives sustained UVA and UVB protection between applications, though consumers should still reapply sunscreen about every two hours.[2]
The mainstream summary emphasizes the approval of bemotrizinol as a significant step forward but overlooks the broader context of skin cancer statistics in the U.S. In 2026, an estimated 112,000 new cases of invasive melanoma and 8,510 deaths are projected, highlighting the urgent need for effective sun protection measures. The summary does not mention that skin cancer is the most common cancer in the U.S., with over 5 million cases of basal cell and squamous cell carcinomas diagnosed annually, which underscores the importance of introducing new sunscreen options like bemotrizinol to combat this public health issue.[4][5]
While the FDA's approval is framed as a modernization effort, critics on social media, such as @Lsleo2465, argue that the 18-month exclusivity granted to DSM undercuts industry claims favoring mineral sunscreens. Furthermore, there is skepticism regarding the FDA's assertion of bemotrizinol's effectiveness, as noted by @sarahdespres, who points out that FDA documents do not explicitly claim it is 'more effective.' This suggests a potential gap between regulatory language and consumer understanding that the mainstream coverage does not address.
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📊 Relevant Data
An estimated 112,000 new cases of invasive melanoma and 8,510 deaths from melanoma are projected in the United States in 2026, with total melanoma diagnoses (including in situ) reaching 234,680.
Cancer Facts & Figures 2026 — American Cancer Society
Skin cancer is the most common cancer in the United States, with more than 5 million cases of basal cell and squamous cell carcinomas diagnosed annually.
Skin Cancer Facts & Statistics — Skin Cancer Foundation
📌 Key Facts
- On Tuesday, June 9, 2026, the FDA amended its list of permissible sunscreen ingredients to add bemotrizinol after finding it meets standards for UV protection and low irritation/absorption (bemotrizinol).
- FDA guidance says sunscreens containing bemotrizinol are considered generally recognized as safe and effective for adults and for children 6 months and older and may be used at concentrations up to 6% (FDA guidance).
- DSM Nutritional Products will market bemotrizinol in the U.S. under the trade name Parsol Shield, expects product launches later in 2026, and will have an 18‑month exclusivity period before other manufacturers can use the ingredient (Parsol Shield).
- A CBS News video segment aired Tuesday, June 9, 2026 at 6:33 PM Central reporting the FDA's same‑day approval and noting the ingredient has been used for years in Europe, with Dr. Jon LaPook saying the move begins to close a regulatory lag for U.S. consumers (CBS News video segment).
- NPR reports bemotrizinol is broadly photostable and can provide sustained UVA and UVB protection between applications, though dermatologists still advise reapplying every two hours (bemotrizinol).
- Environmental Working Group scientist Alexa Friedman says safety testing showed bemotrizinol did not cause reproductive harm in animals and did not irritate human skin even with repeated applications over time (Alexa Friedman).
- Dermatologist Heather Rogers says U.S. chemical filters have relied mainly on avobenzone for UVA protection, which breaks down quickly in sunlight and can release skin‑irritating byproducts (Heather Rogers).
- NPR reports DSM‑Firmenich spent at least $18 million over more than two decades to secure FDA approval for bemotrizinol, underscoring the cost and length of the process (DSM‑Firmenich).
- Fox quotes FDA Commissioner Marty Makary saying the agency has historically moved too slowly on sunscreen approvals and is working to modernize OTC regulation, and FDA official Karen Murry called bemotrizinol a welcome addition and said the agency looks forward to working with other companies on additional ingredients (Marty Makary).
📰 Source Timeline (4)
Follow how coverage of this story developed over time
- The NPR piece emphasizes that bemotrizinol is broadly photostable and can provide sustained UVA and UVB protection between applications, though dermatologists still advise reapplying every two hours.
- Dermatologist Heather Rogers says U.S. chemical filters have relied mainly on avobenzone for UVA protection, which breaks down quickly in sunlight and can release skin-irritating byproducts.
- Environmental Working Group scientist Alexa Friedman says safety testing shows bemotrizinol did not cause reproductive harm in animals and did not irritate human skin even with repeated applications over time.
- Cosmetic chemist Kelly Dobos notes that, because U.S. sunscreens are regulated as over-the-counter drugs rather than cosmetics, bemotrizinol required extensive safety and efficacy data before approval.
- NPR reports DSM-Firmenich spent at least $18 million over more than two decades to secure FDA approval for bemotrizinol, underscoring the cost and length of the process.
- Fox News reiterates that on Tuesday, June 9, 2026, the FDA formally amended its list of permissible sunscreen ingredients to add bemotrizinol after finding it meets standards for UV protection and low irritation/absorption.
- The article specifies that DSM Nutritional Products will market bemotrizinol in the U.S. under the trade name Parsol Shield and expects to launch products later in 2026.
- Fox reports that DSM will have an 18‑month exclusivity period in the U.S. market before other manufacturers can use bemotrizinol.
- The piece quotes FDA Commissioner Marty Makary saying the agency has historically moved too slowly on sunscreen approvals, leaving Americans with fewer options than consumers abroad, and that FDA is working to modernize OTC regulation.
- The article quotes Karen Murry of FDA’s Office of Nonprescription Drugs calling bemotrizinol a welcome addition to existing sunscreen actives and saying the agency looks forward to working with other companies on additional ingredients.
- The article reiterates FDA guidance that sunscreens containing bemotrizinol will be considered generally recognized as safe and effective for adults and for children 6 months and older, and may be used at concentrations up to 6%.
- The CBS News video segment aired at 6:33 p.m. Central on Tuesday, June 9, 2026, further detailing the FDA's same-day approval of a new sunscreen ingredient that has been used for years in Europe.
- Dr. Jon LaPook is cited on-air as explaining that the newly approved ingredient has long been available in European sunscreens, underscoring the regulatory lag the decision begins to close for U.S. consumers.