FDA Approves New Sunscreen Chemical While US Tops World in Sunscreen Sales and Skin Cancer Rates
Updated
The FDA approved bemotrizinol as an active ingredient for sunscreen more than 25 years after it was approved in Europe, and it is also the first update to sunscreen chemicals approved in the US in over 25 years. Bemotrizinol has skin absorption levels below the concentration considered systemic by the FDA, whereas traditional sunscreen ingredients like oxybenzone have been detected at 515 times the FDA’s threshold of concern. Bermotrizinol also has significant UVA protection, while traditional sunscreen formulations have failed to find chemicals with effective UVA protection.
The FDA issued the proposed rule in December, followed by a public comment period, and has now issued a final rule authorizing the use of the chemical for sunscreen. The approval of bemotrizinol is part of the Make America Healthy Again (MAHA) strategy goal of promoting innovation and regulatory processes for the sunscreen market. HHS Secretary Robert F. Kennedy Jr. said, “FDA’s action will increase competition and consumer confidence in sunscreen products.”
In 2020, research funded by the FDA Center for Drug Evaluation and Research (CDER) conducted a study that found seven chemicals regularly used in sunscreen formulations absorb into the bloodstream after a single use above safety thresholds determined by the FDA. Homosalate and oxybenzone were still detected in the bloodstream above the threshold after 21 days.
The Personal Care Products Council and the Consumer Healthcare Products Association reacted to the study at the time by stating, “The presence of these ingredients in plasma does not suggest a safety issue, and there were no serious drug-related adverse events reported in the trial.”
Dr. Janet Woodcock, the director of CDER at the time, said it is not necessarily unsafe if the ingredients are detected in the bloodstream above safety thresholds. Rather, she said, more studies and research need to be conducted.
The FDA, as part of the 2020 CARES Act, streamlined a new approval process for new chemicals, but temporarily grandfathered in the legacy ingredients while not granting them the “generally recognized as safe and effective (GRASE) designation. The FDA has asked manufacturers to provide additional research to support the safety and efficacy of these other ingredients, and there has been no action on this since the final order was issued in 2021.
“For decades, Americans have used outdated sunscreen tech while the rest of the world moved forward,” said David Andrews, Ph.D., chief science officer at the Environmental Working Group (EWG). “The approval of bemotrizinol will help change that. The FDA’s go-ahead will finally bring more effective, safer sun protection to American store shelves. This is a win that has been a long time coming.”
The EWG has been advocating for sunscreen reform to allow other ingredients that are more effective and less likely to enter the bloodstream. The organization conducted peer-reviewed research that found that US sunscreen only provides an average of 24% UVA protection of the advertised UPF value.
“For too long, American consumers have been applying sunscreen and believing they were fully protected, not knowing that their product was delivering far less UVA protection than the label implied,” said Alexa Friedman, Ph.D., senior scientist at EWG. “Bemotrizinol changes the calculus of sun care. It is highly photostable, meaning it won’t break down when hot summer sun hits your skin – unlike avobenzone, currently the only non-mineral filter in the U.S. that provides meaningful UVA coverage.”
The US has the highest cancer rate per capita and the highest per capita sales of sunscreen in the world. According to the Global Burden of Disease study in 2021, the US had an age-standardized incident rate (ASIR) of 813.53 new skin cancer cases per 100,000 people. This is 10.5 times higher than the global average of 77.66, 30 times higher than Eastern Europe, and nearly 15 times higher than Western Europe. The US buys 3.4 units of sunscreen per person, while Europe consumes 2.8 units of sunscreen per person.
A 2024 UK Biobank study explicitly found a link between frequent sunscreen use and the incidence of skin cancer. The authors found a 292% higher risk of melanoma, 140% higher risk of basal cell carcinoma, and 126% higher risk of squamous cell carcinoma. The study was observational, so the results do not prove causality. The researchers did adjust for other known skin cancer risk factors, and the high association between frequent sunscreen users and skin cancers remained.
Health officials recommend people wear sunscreen to prevent skin cancer, but the US has the highest usage of sunscreen and the highest rates of cancer. The approval of bemotrizinol reflects the first significant change to sunscreen in a quarter of a century. DSM-Firmenich spent at least $18 million over two decades attempting to get the chemical approved by the FDA and will have an exclusive 18-month right to market sunscreen with the ingredient in the US. It will be sold under the brand name Parsol Shield. After 18 months, other companies will have the right to use the ingredient without facing the full FDA approval process.