FDA: Broad spectrum sunscreens and SPF below 15
All sunscreen products are considered over-the-counter (OTC) products and are required to be in the “Drug Facts” format.
The FDA states that a sunscreen must protect equally against both types of sun radiation (UVB and UVA)
to be considered “broad spectrum".
Broad Spectrum sunscreens with an SPF value 15 or higher can claim to reduce the risk of skin cancer
and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum
sunscreens, and Broad Spectrum sunscreens with an SPF value lower than 15, can only claim to “help
prevent sunburn".
Any sunscreen product that is not Broad Spectrum, or that is Broad Spectrum with an SPF value less
than 15, requires a warning statement. The wording of this warning has been revised to state, ‘‘Skin
Cancer/Skin Aging Alert: [in bold font] Spending time in the sun increases your risk of skin cancer
and early skin aging. This product has been shown only to help prevent sunburn, not [in bold font]
skin cancer or early skin aging.
See FDA
