FDA Announces Changes to Sunscreen Labeling

“Broad-spectrum” protection is now strictly defined.

On June 14, 2011, the FDA issued long-awaited modifications to requirements for sunscreen labeling. Sunscreens can no longer be labeled “broad spectrum” unless they meet the FDA testing standards for ultraviolet (UV) A protection. Protection against UVA is not included in the sun protection factor (SPF) number. A sunscreen that meets UVA sun protection standards and has a UVB SPF of 15 or higher can maintain that it is “broad spectrum” and that it protects against skin cancer and limits skin photoaging. Sunscreens that provide UVA protection but have a UVB SPF of 2 to 14 can call themselves “broad spectrum” but must carry a warning that they do not protect against skin cancer or early skin aging. Sunscreens that are not broad spectrum must …

Authors

Craig A. Elmets, MD

Disclosures

Consultant / Advisory board Astellas Pharmaceuticals

EquityVaxin

Grant / Research support NIH; NIH/NCI; Veteran’s Administration; Ferndale Laboratories; Kyowa Hakko Kirin Pharma, Inc.

Editorial boards Cancer Prevention Research; Photodermatology, Photoimmunology, & Photomedicine; UpToDate; eMedicine; Journal of Dermatological Sciences; JAMA Dermatology

Leadership positions in professional societies American Academy of Dermatology (Vice Chair, Committee on Science and Research); Photomedicine Society (Board of Directors)

Craig A. Elmets, MD

Disclosures

Consultant / Advisory board Astellas Pharmaceuticals

EquityVaxin

Grant / Research support NIH; NIH/NCI; Veteran’s Administration; Ferndale Laboratories; Kyowa Hakko Kirin Pharma, Inc.

Editorial boards Cancer Prevention Research; Photodermatology, Photoimmunology, & Photomedicine; UpToDate; eMedicine; Journal of Dermatological Sciences; JAMA Dermatology

Leadership positions in professional societies American Academy of Dermatology (Vice Chair, Committee on Science and Research); Photomedicine Society (Board of Directors)

Robert Sidbury, MD