New steps are being made by the Food and Drug Administration (FDA) that will help protect consumers from skin damage caused by the harmful rays of the sun. The following measures are listed in the report:
- 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+”.
- A data request for safety and effectiveness information for sunscreen products formulated in certain dosage forms (e.g., sprays).
- A draft guidance for sunscreen manufacturers on how to test and label their products in light of these new measures.
“This new information will help consumers know which products offer the best protection from the harmful rays of the sun,” says Lydia Velazquez, Pharm.D. in FDA’s Division of Nonprescription Regulation Development. She said that the measures are necessary since “our scientific understanding has grown” and it is important for consumers “to understand that not all sunscreens are created equal.”
The FDA’s regulations will become effective in one year. The regulations will provide a standard test for sunscreen products that are sold over-the-counter which will determine if the products can be labeled as “Broad Spectrum.” The term broad spectrum means protection from both ultraviolet B (UVB) and ultraviolet A (UVA) rays.
The FDA has come up with additional labeling regulations designed to help consumers select the right sunscreens and teach them how to use them properly. Here are the additional labeling regulations from the FDA’s recent report:
- Sunscreen products that are not broad spectrum or that are broad spectrum with SPF values from 2 to14 will be labeled with a warning that reads: “Skin Cancer/Skin Aging Alert: 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 skin cancer or early skin aging.”
- Water resistance claims on the product’s front label must tell how much time a user can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing. Two times will be permitted on labels: 40 minutes or 80 minutes.
- Manufacturers cannot make claims that sunscreens are “waterproof” or “sweatproof, or identify their products as “sunblocks.” Also, sunscreens cannot claim protection immediately on application (for example, “instant protection”) or protection for more than two hours without reapplication, unless they submit data and get approval from FDA.
Since each and every one of us is exposed to the sun, we need to pay close attention to these new regulations. Any time that we spend in the sun increases our chance of skin cancer and each time we get a sun burn that risk is heightened. Not to mention, it also causes early skin aging. The FDA report lists the following steps we should follow in order to reduce our risk in the sun:
- Use sunscreens with broad spectrum SPF values of 15 or higher regularly and as directed.
- Limit time in the sun, especially between the hours of 10 a.m. and 2 p.m., when the sun’s rays are most intense.
- Wear clothing to cover skin exposed to the sun; for example, long-sleeved shirts, pants, sunglasses, and broad-brimmed hats.
- Reapply sunscreen at least every 2 hours, more often if you’re sweating or jumping in and out of the water.
For more detailed information click here to read the full report from the FDA.