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 requirements support the Agency’s ongoing efforts to ensure that sunscreens meet modern-day standards for safety and effectiveness.
Prior rules on sunscreens dealt almost exclusively with protection against sunburn, which is primarily caused by ultraviolet B (UVB) radiation from the sun, and did not address ultraviolet A (UVA) radiation, which contributes to skin cancer and early skin aging. After reviewing the latest science, FDA determined that sufficient data are available to establish a “broad spectrum” test for determining a sunscreen product’s UVA protection. Passing the broad spectrum test shows that the product provides UVA protection that is proportional to its UVB protection.
Sunscreen products that pass the broad spectrum test are allowed to be labeled as “Broad Spectrum.” These “Broad Spectrum” sunscreens protect against both UVA and UVB rays. Scientific data demonstrated that products that are “Broad Spectrum SPF 15 [or higher]” have been shown to reduce the risk of skin cancer and early skin aging when used with other sun protection measures, in addition to helping prevent sunburn. Other sun protection measures include limiting time in the sun and wearing protective clothing.
These measures are necessary, says Lydia Velazquez, PharmD, in FDA’s Division of Nonprescription Regulation Development, because “our scientific understanding has grown. We want consumers to understand that not all sunscreens are created equal.”
“This new information will help consumers know which products offer the best protection from the harmful rays of the sun,” Velazquez says. “It is important for consumers to read the entire label, both front and back, in order to choose the appropriate sunscreen for their needs.”
Everyone is potentially susceptible to sunburn and the other detrimental effects of exposure to UV radiation.
Products that pass the broad spectrum test will provide protection against both ultraviolet B radiation (UVB) and ultraviolet A radiation (UVA). Sunburn is primarily caused by UVB. Both UVB and UVA can cause sunburn, skin cancer, and premature skin aging. A certain percentage of a broad spectrum product’s total protection is against UVA.
Under the new regulations, sunscreen products that protect against all types of sun-induced skin damage will be labeled “Broad Spectrum” and “SPF 15” (or higher) on the front.
The new labeling will also tell consumers on the back of the product that sunscreens labeled as both “Broad Spectrum” and “SPF 15” (or higher) not only protect against sunburn, but, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging. For these broad spectrum products, higher SPF (Sun Protection Factor) values also indicate higher levels of overall protection.
By contrast, any sunscreen not labeled as “Broad Spectrum” or that has an SPF value between 2 and 14, has only been shown to help prevent sunburn.
In addition to the final regulations, in June 2011 FDA proposed a regulation that would require sunscreen products that have SPF values higher than 50 to be labeled as “SPF 50+.” FDA does not have adequate data demonstrating that products with SPF values higher than 50 provide additional protection compared to products with SPF values of 50.
FDA also requested data and information on different dosage forms of sunscreen products. The agency currently considers sunscreens in the form of oils, creams, lotions, gels, butters, pastes, ointments, sticks, and sprays to be eligible for potential inclusion in the OTC sunscreen monograph – meaning that they can be marketed without individual product approvals.
The agency currently considers wipes, towelettes, powders, body washes, and shampoo not eligible for the monograph. Therefore, they cannot be marketed without an approved application.
For sunscreen spray products, the agency requested additional data to establish effectiveness and to determine whether they present a safety concern if inhaled unintentionally. These requests arose because sprays are applied differently from other sunscreen dosage forms, such as lotions and sticks.
In addition, FDA issued a draft guidance to help sunscreen manufacturers understand how to label and test their products in light of the final and proposed regulations and the data request on dosage forms.
Sun Safety Tips
- 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.
- Hydrate! Drink lots of water and good fluids! (Soda products will just make you more thirsty, so try homemade lemonade or iced tea, or just plain water.
- Wear protective eye ware! Even children should wear real sunglasses with UV protection, not just those play sunglasses.
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