In 2014, the Sunscreen Innovation Act (SIA) established a new review process for analyzing the safety and efficacy of new active ingredients added to OTC sunscreens. At that time, eight active ingredients were already under review by the FDA to determine whether they were generally recognized as safe and effective (GRASE) for OTC sunscreens. On November 22, the FDA released a final guidance document recommending that the industry perform Maximum Usage Trials and share data from the trial results to help the FDA determine if some active ingredients are absorbed into the skin and blood, and in what amounts. The guidance document also recommended that data from human dermal safety studies (which includes human irritation and sensitization studies, and human photosafety studies) and pediatric considerations be shared with the FDA for GRASE determination. In regards to nonclinical safety testing, the FDA recommended that dermal and systemic carcinogenicity studies be conducted for OTC sunscreen active ingredients by applying the ingredient-infused products onto rats or mice over a six-month to two-year period. Developmental and reproductive toxicity studies and toxicokinetics are also recommended to ensure that active OTC sunscreen ingredients do not have negative neuroendocrine effects.
Source: FDA