Starting next summer, sunscreens with less than an SPF of 15 or that aren't "broad spectrum" will have to carry a warning label: "This product has been shown only to help prevent sunburn, not skin cancer or early skin aging."
"For the first time, the FDA has clearly defined the testing required to make a broad-spectrum protection claim in a sunscreen and indicate which type of sunscreen can reduce skin cancer risk," said Dr. Ronald L. Moy, president of The American Academy of Dermatology Association.
Under the new rules:
• The FDA will prohibit sunscreen marketing claims like "waterproof" and "sweatproof," which the agency said "are exaggerations of performance."
• The FDA also proposes capping the highest SPF value at 50, unless companies can provide results of further testing that support a higher number.
• FDA says manufacturers must phase out a four-star system currently used by some companies to rate UVA protection.
In reviewing more than 3,000 comments submitted to the agency, the FDA decided the star system was too confusing. Instead, protection against UVA should be proportional to protection against UVB, which is already measured using SPF.
The SPF figure indicates the amount of sun exposure needed to cause sunburn on sunscreen-protected skin compared with unprotected skin. For example, an SPF rating of 30 means it would take the person 30 times longer to burn wearing sunscreen than with exposed skin.
Most dermatologists recommend a broad spectrum, water-resistant sunscreen of SPF 30 or higher every two hours while outside.
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