Clinical Drug Experience Knowledgebase

Sulisobenzone (benzophenone-4) is an ingredient for use in sunscreens which protects the skin from damage by UVB and short-wave UVA ultraviolet light. The Food and Drug Administration (FDA) has approved the use of Benzophenone-4 as safe and effective, over-the-counter (OTC) sunscreen ingredient. Sulisobenzone is a subject to the FDA 2011 sunscreen final rule: it can be marketed without approved drug applications (without NDAs or ANDAs), must bear the statement of identity “sunscreen" and contain the information about SPF test. However it is said to be widely used in cosmetic products not labeled as sunscreens such as creams, moisturizers, shampoos and other hair care products, nail polish, lipsticks and lip balms. Sulisobenzone may cause contact dermatitis when used in cosmetics and toiletries. Benzophenone 4 is tested as 10%. It was reported that 10% sulisobenzone enhance skin penetration of the moderately lipophilic herbicide 2,4-D.   ^NCATS