Plaintiffs allege that Coppertone sunscreens are deceptively labeled as “mineral-based” when they contain a larger percentage of chemical active ingredients than mineral active ingredients. On 31 July, California’s Northern District roundly rejected defendants’ motion to dismiss.

Industry advocates working to support GRASE determinations for eight UV filters are faced with a dilemma. They would like to share nonpublic studies with the FDA on a confidential basis – at least to get initial temperature readings from the agency as to the studies’ usefulness in addressing data gaps – but under the current OTC monograph framework, no such pathway exists.

The Germany-based skin-care specialist will pay Bayer $550m for the iconic brand and gain entry to the US sunscreen market. The US represents the world’s biggest opportunity for sun care, but it’s also rife with uncertainty following FDA’s recent call for data to support key active ingredients’ continued GRASE status.