The US has broken a two-decade drought with the Food and Drug Administration (FDA) adding bemotrizinol to the list of approved active ingredients that can be used in sunscreen, paving the way for more effective protection from ultraviolet (UV) light.
“Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen productsm" said Department of Health and Human Services Secretary Robert F. Kennedy, Jr in a statement.
Bemotrizinol shields the skin against both UVA and UVB rays, and has a low rate of absorption into the body. The FDA classes it as "generally recognized as safe and effective" (GRASE) in sunscreen products for both adults and children aged six months and older.
The first products containing this new ingredient are expected to be available over the counter the end of 2026 under the PARSOL Shield name.
Essentially, it's an advanced sunscreen filter, which has been common in products found across Europe and Asia, which offers broad-spectrum UVA and UVB protection. It's photostable and effective at concentrations up to 6%. And is considered extremely safe, with low traces found in plasma analysis. So it stays on, rather than soaks into, the skin.
It's now expected to pave the way for a new generation of sunscreens in the US, which have not advanced much since the 1990s.
“This is exactly the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions,” said Mike Davis, M.D., Acting Director of the FDA Center for Drug Evaluation and Research (CDER). “The FDA is committed to ensuring the American consumer has access to the most effective and safe therapies, including over-the-counter products like sunscreens.”
Introduced for review and approval back in December, it's taken just seven months for bemotrizinol to get the green light. It's passed through each stage and the FDA will now issue a final order, allowing it to be used in innovative new sun-protection products at up to 6% concentration.
While existing US sunscreens offer strong protection, bemotrizinol delivers broad-spectrum coverage and is highly photostable. This means it doesn't degrade in sunlight, making it more effective and long-lasting.
It's also ideal for people with sensitive skin, as it has a low risk of irritation. Ultimately, it is expected to lead to lighter creams and lotions that are less likely to leave a white sheen, especially compared to mineral-only products.
And because of this, these lightweight sunscreens are more likely to be used properly and consistently by consumers.
Skin cancer – which includes basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) – is the most common cancer in the US, with an estimated 90% of non-melanoma cases the direct result of exposure to UV radiation. According to the US Skin Cancer Foundation, more people are diagnosed with skin cancer each year than all other cancers combined.
Source: US Food and Drug Association
