SILVER SPRING, Md.—FDA is taking steps to help protect consumers from painful and dangerous hazards of summer: sunburn and its damage to the skin. The new measures clarify the effectiveness of sunscreen products and help ensure their proper labeling and manufacture.
Final regulations that become effective next year define the characteristics of over-the-counter (OTC) sunscreens with broad spectrum protection and SPF values of 15 or higher. These products shield users against two types of radiation from the sun: UVB, which is primarily responsible for causing sunburn; and UVA, which contributes to sunburn, skin cancer and premature skin aging.
The new measures include:
- Final regulations that establish standards for testing the effectiveness of sunscreen products and require labeling that accurately reflects test results;
- A proposed regulation that would limit the maximum SPF value on sunscreen labeling to “SPF 50+";
- Data request for safety and effectiveness information for sunscreen products formulated in certain dosage forms (e.g., sprays); and
- A draft guidance for sunscreen manufacturers on how to test and label their products in light of these new measures.
These measures are necessary, according to Lydia Velazquez, FDA Division of Nonpregascription Regulation Development, because “our scientific understanding has grown. We want consumers to understand that not all sunscreens are created equal."
To learn more about the new FDA regulations governing OTC sunscreens click here.