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By Linda W. Lewis

On June 14, 2011, the United States Food and Drug Administration (www.fda.gov) issued its long-awaited Final Sunscreen Monograph. While it did not address every issue in the proposed monograph, it did usher in some welcome changes. The Proposed Monograph called for a two-tier labeling system for sunscreens: an SPF number to designate UVB protection and a rating system of one to four stars to designate UVA protection. The Final Monograph settled instead on a broad-spectrum SPF value that will cover both UVB and UVA protection. The SPF value will be determined by critical wavelength (CW) testing, rather than the ratio derived from a combination of CW and persistent pigment darkening (PPD) testing called for in the proposal. Only sunscreens that pass designated test levels for UVA and UVB protection can be labeled “Broad Spectrum.” Broad-spectrum sunscreens with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging when used as directed. Those with an SPF 2 to 14 that are not broad-spectrum can claim only sunburn prevention.
Any product claiming antiaging or skin cancer prevention based on sunscreen action must submit appropriate test data to the FDA.
No sunscreen label can claim to be a “sunblock” or that it is “waterproof” or “sweatproof.” Water resistance claims of 40 minutes or 80 minutes can be made if the formulation passes standard tests.
No sunscreen label can claim to provide sun protection for more than two hours without reapplication, nor can it claim instant or immediate protection, unless submitted test data support those claims.
All sunscreen labels must now include a drug facts box that will include appropriate warnings. For example, products with an SPF number below 15 will have to warn that they do not protect against skin cancer.

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