North America

Regulatory considerations regarding sunscreen actives via New York Society of Cosmetic Chemists

Summer is here, and it is time to enjoy outdoor activities and the beautiful landscape with friends and family. However, the Sun is bright and scorching, making the weather hot and the use of sunscreen essential. Sunscreen, sunscreen, sunscreen!

When developing sunscreen products, it is crucial to focus not only on performance and aesthetics to meet consumer expectations but also on regulatory compliance. Sunscreen products are regulated worldwide and are classified as drugs by the FDA. For the US market both the manufacturers of sunscreen products and the actives (considered as Active pharmaceutical ingredients (APIs)) used in these products must comply with FDA requirements, including registration and listing, as well as adherence to ICH Q7A Current Good Manufacturing Practices.

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