Skin cancer is the most common malignancy in the United States and is estimated to affect more than 3.3 million individuals each year.1 Photoprotection, including sunscreen use for areas of skin not covered by sun protective clothing or shade, aims to reduce exposure to UV radiation, likely the main risk factor for the development of skin cancer.
Sunscreens were initially approved as over-the-counter (OTC) medications—indicated for the prevention of sunburn—before the modern era of drug evaluation. Current understanding of UV-related carcinogenesis supports the additional indication regarding use of sunscreen for the prevention of skin cancer. However, because biological rationale has so often proven to be misleading, drug manufacturers must demonstrate through empirical research in humans that benefits outweigh risks for an intended use of a product in a specified population. Has sunscreen met these current requirements for safety and effectiveness?