The First New FDA Sunscreen Ingredient Addition in More Than 20 Years The U.S. Food and Drug Administration (FDA) has added bemotrizinol to the list of permitted sunscreen active ingredients, marking the first new FDA sunscreen ingredient addition to the OTC sunscreen monograph since the late 1990s. The decision represents an important regulatory milestone for the U.S. sunscreen industry and may create new opportunities for product innovation in the years ahead. What Is Bemot

In the United States, sunscreens are regulated as OTC (Over-the-Counter) drugs , not cosmetics. This means they are subject to strict regulatory frameworks governing everything from ingredients and SPF testing to labeling and safety standards. Recent FDA announcements do not necessarily mean an immediate overhaul of all existing rules. Instead, they signal a strategic update to OTC Monograph M020 , clarifying the standards and direction for future sunscreen regulations. How i