The Food and Drug Administration on Monday approved the first new active ingredient for over-the-counter sunscreens in more than 20 years, giving American consumers access to a product that has been widely available in Europe, Asia, and countries in other regions for decades.
The agency added bemotrizinol to its sunscreen monograph at concentrations of up to 6 percent. Bemotrizinol is the first approved chemical sunscreen filter that offers broad-spectrum protection against both UVA and UVB rays, the FDA said. It also demonstrates low levels of absorption through the skin, making it safer for young children, and it rarely causes irritation.
The FDA determined that the organic chemical is generally recognized as safe and effective for adults and children 6 months and older….