Dr. Paul Auerbach is the world's leading outdoor health expert. His blog offers tips on outdoor safety and advice on how to handle wilderness emergencies.See all posts »
FDA Announces Changes to Sunscreen Rules
Preventing skin cancer and skin aging are the most important goals of using sunscreens, which should be applied to all exposed skin from an early age. From the FDA website, here is an important announcement and additional information:
On June 14, 2011 the U.S. Food and Drug Administration (FDA) announced new requirements for sunscreens currently sold over-the-counter (OTC) (i.e. non-prescription). These changes will help consumers decide how to buy and use sunscreens, and allow them to more effectively protect themselves and their families from sun-induced damage. Sunscreen products that meet modern standards for effectiveness may be labeled with new information to help consumers find products that, when used with other sun protection measures, reduce the risk of skin cancer and early skin aging, as well as help prevent sunburn. These new requirements are part of an ongoing effort to ensure sunscreens meet modern-day standards for safety and efficacy and are based on the latest science available. They will also reduce confusion about sunscreen.
The new requirements, as well as several proposed changes for future rules, are outlined in four regulatory documents that include a Final Rule (takes effect by the summer of 2012), a Proposed Rule, an Advance Notice of Proposed Rulemaking, and a Draft Guidance for Industry.
Rules on UVA and UVB Protection
Prior rules on sunscreens dealt almost exclusively with protection against only ultraviolet B (UVB) radiation from the sun, and did not address skin cancer and early skin aging caused by ultraviolet A (UVA) rays. After reviewing the latest science, FDA determined that sufficient data are available to establish a standard broad-spectrum test procedure that measures UVA radiation protection in relation to the amount of UVB radiation protection. This designation will give consumers better information on which sunscreen products offer the greatest protection from both UVA and UVB exposure—both of which can lead to an increased risk of skin cancer.
Manufacturers whose sunscreen products pass this new broad-spectrum test will be able to label the products as "Broad Spectrum." These "Broad Spectrum" sunscreens protect against both UVA and UVB rays. For "Broad Spectrum" sunscreens, the "Sun Protection Factor" (or SPF) also indicates the overall amount of protection provided. These rules will go into effect for the summer of 2012.
According to the proposed rules rules, only Broad Spectrum sunscreens with an SPF value of 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 between two and 14 can only claim to help prevent sunburn. The SPF value on these products refers only to their ability to prevent sunburn.
Rules on Marketing Claims
Another aspect of the proposed rules relates to claims of water- and sweat-proof. Manufacturers can no longer label sunscreens as "waterproof" or "sweatproof," or identify their products as "sunblocks," because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than two hours without reapplication or to provide protection immediately after application (e.g., "instant protection") without submitting data to support these claims and obtaining FDA approval.
Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
The proposed rule, if finalized, would limit the maximum SPF value on sunscreen labels to "50 +" because there is not sufficient data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.
Preventing Skin Cancer and Early Skin Aging
Spending time in the sun increases a person's risk of skin cancer and early skin aging. To reduce these risks, consumers should regularly use a Broad Spectrum sunscreen with an SPF value of 15 or higher in combination with other protective measures such as:
- Limiting time in the sun, especially between the hours of 10 AM and 2 PM when the sun's rays are the strongest.
- Wearing clothing to cover skin exposed to the sun (long-sleeved shirts, pants, sunglasses, and broad-brimmed hats).
- Using a water resistant sunscreen if swimming or sweating.
- Reapplying sunscreen, even if it is labeled as water resistant, at least every two hours. Water resistant sunscreens should be reapplied more often after swimming or sweating, according to the directions on the label.
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