Human safety and efficacy of ultraviolet filters and sunscreen products.

Ultraviolet (UV) filters are the active ingredients in sunscreens. The concentration and combination of UV filters determine the efficacy of sunscreens as measured by sun protection factor. The safety of individual UV filters, and, more generally, sunscreen products, is a matter of a few related components: objective toxicologic evaluation, phototoxicologic potential, and human health consequences of using products that may reduce some but not all of the solar UV. Of 16 UV filters approved by the US Food and Drug Administration, 9 are used in different combinations in the most currently marketed sunscreens. Most of these compounds are considered safe and effective alone or in combination with other UV filters based on extensive toxicologic/phototoxicologic evaluations and market history. The benefits from proper use of sunscreens outweigh real or perceived human health concerns, establishing a favorable benefit-to-risk ratio. Future UV filters will require complete human safety evaluations alone and in combination with select benchmark ingredients.