After 20 years, the United States has finally "added ingredients" to local sunscreen products. According to the latest announcement by the U.S. Food and Drug Administration (FDA), a chemical sunscreen filter called "bemotrizinol" has been officially included in the list of active ingredients that can be used in sunscreen products, paving the way to improve ultraviolet (UV) protection.
U.S. Secretary of Health and Human Services Robert F. Kennedy (Jr.) said that bemotrizinol has been used safely in Europe for decades, and its approval will not only increase market competition, but also help enhance consumer confidence in sunscreen products. This ingredient protects against both UVA and UVB rays and has a low absorption rate by the human body. The FDA has designated it as "generally recognized as safe and effective" (GRASE) for sunscreen use in people six months of age and older.
According to the plan, the first batch of over-the-counter sunscreen products containing this ingredient are expected to be launched on the US market under the trade name "PARSOL Shield" by the end of 2026. Bemotrizinol is essentially an advanced sunscreen filter that has long been widely used in sunscreen products in Europe and Asia and has broad-spectrum UVA/UVB protection capabilities. It has good photostability, remains effective at the highest dosage of 6%, and has extremely low residue levels in plasma tests, which means it stays on the skin surface rather than entering the human circulation system.
The industry expects that this approval will bring a new generation of sunscreen products to the US market. At present, the sunscreen technology in the United States is still at the level of the 1990s, and there is a certain gap between it and Europe and Asia. Dr. Mike Davis, Acting Director of the FDA's Center for Drug Evaluation and Research (CDER), said that this is an example of modernizing the regulatory process and promoting progress through scientific decision-making. The FDA will continue to be committed to giving American consumers access to safer and more effective treatment options, including over-the-counter sunscreen products.
Bemotrizinol was formally submitted for review in December last year and was approved in only about seven months. At present, all relevant review procedures have been passed, and the FDA will issue a final order allowing companies to use this ingredient at a maximum content of 6% in innovative sunscreen products. Although existing American sunscreen products can already provide strong protection, the introduction of this new ingredient will give the product more stable broad-spectrum protection. Its high photostability means it is less likely to break down under sunlight and the protective effect is longer lasting.
In addition, bemotrizinol is more friendly to people with sensitive skin and has a lower risk of causing skin irritation. Experts predict that new sunscreens and lotions will appear on the market that are thinner and less likely to whiten. Especially compared to products that rely solely on physical sunscreens (mineral sunscreens), they are less likely to leave an obvious white film on the skin. Formulas that are lighter and feel better on the skin are expected to increase users' enthusiasm and standardization of daily sunscreen use.
Skin cancer (including basal cell carcinoma and squamous cell carcinoma) is the most common type of cancer in the United States, and an estimated 90% of non-melanoma skin cancer cases are directly related to UV exposure. The Skin Cancer Foundation of America states that more people are diagnosed with skin cancer each year than all other cancers combined. Against this epidemiological background, regulators and the industry generally believe that the introduction of safer and more efficient broad-spectrum sunscreen ingredients will have an important impact on public health.