FDA Approves First New Sunscreen Ingredient For U.S. In 25 Years
The Food and Drug Administration approved bemotrizinol as a new active ingredient for U.S. sunscreens on Tuesday, June 9, 2026, marking the first such authorization in about 25 years.[1]
A CBS News video segment aired at 6:33 p.m. Central Tuesday and reported that the ingredient has long been used in European sunscreens, a development experts said begins to close a regulatory gap for U.S. consumers.[2]
Bemotrizinol, also called BEMT or Parsol Shield, is a broad-spectrum, photostable UV filter permitted at concentrations up to 6 percent and cleared for use on adults and children 6 months and older.
On March 27, 2020, Congress passed the CARES Act, which created a faster administrative review path for over-the-counter ingredients and an 18-month exclusivity incentive. DSM Nutritional Products filed the first Tier 1 Monograph Order Request for bemotrizinol in September 2024, and the FDA issued a proposed order in December 2025.
Manufacturers may include bemotrizinol in new or reformulated sunscreens beginning August 9, 2026, and products using the ingredient are expected to appear later in 2026.
The mainstream summary does not address the significance of bemotrizinol's approval in the context of U.S. regulatory practices compared to Europe. While the FDA's approval is framed as a positive development, experts emphasize that the U.S. has lagged behind in sunscreen options, with bemotrizinol being used in Europe since 2000. This delay is attributed to the U.S. classification of sunscreen ingredients as over-the-counter drugs, which subjects them to rigorous testing akin to pharmaceuticals, creating a lengthy approval process. In contrast, the EU treats these products as cosmetics, allowing for a more streamlined introduction of new ingredients. This regulatory divergence has left American consumers with fewer choices, a point that is notably absent from the mainstream coverage. The approval process for bemotrizinol, enabled by the CARES Act, is seen as a crucial step toward closing this gap and providing U.S. consumers with access to safer and more effective sunscreen options already available abroad.
Furthermore, the mainstream summary does not highlight the specific benefits of bemotrizinol that have been discussed on social media, such as its superior UVA/UVB protection, photostability, and minimal skin absorption, which contrast with older ingredients like oxybenzone. These factors not only enhance consumer safety but also reflect a broader movement towards improving public health standards in sunscreen formulations. The approval is thus not merely a regulatory milestone; it represents a significant shift in consumer health policy that has been long awaited by advocates and scientists alike.
Show source details & analysis (2 sources)
📊 Relevant Data
The approved ingredient is bemotrizinol (also known as BEMT or Parsol Shield), a broad-spectrum, photostable UV filter permitted at concentrations up to 6% for use in sunscreens by adults and children 6 months and older.
FDA Expands Sunscreen Options for First Time in 20+ Years — FDA
Sunscreen manufacturers may include bemotrizinol as an active ingredient beginning August 9, 2026, with new or reformulated products expected later in 2026.
FDA approves first new sunscreen ingredient since the 1990s — Courier-Journal
Melanoma of the skin incidence rate was 22.3 new cases per 100,000 men and women per year (age-adjusted).
Cancer Stat Facts: Melanoma of the Skin — SEER (National Cancer Institute)
📌 Key Facts
- The FDA's same-day approval authorized a new sunscreen ingredient for U.S. use.
- The newly approved ingredient has been used for years in European sunscreens.
- Dr. Jon LaPook said on-air that the ingredient has long been available in Europe and that the decision begins to close a regulatory lag for U.S. consumers.
- A CBS News video segment titled "FDA approves new sunscreen ingredient" covered the FDA approval.
- The CBS News video segment aired at 6:33 p.m. Central on Tuesday, June 9, 2026.
📰 Source Timeline (2)
Follow how coverage of this story developed over time
- 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.