I was sitting in the airport the other day waiting for my airplane and CNN Broadcasted that the Food and Drug Administration, FDA, will be enforcing changes on sunblock makers. As a mom, buying sunblock and be very confusing, what SPF is best, what brand is best, do I need to worry about chemicals, or what about waterproof verses sport? How can we possibly be expected to make a decision with all of the sunblock brands out there blasting that theirs is the best?
The new rules will specify which lotions provide the best protection against the sun and prohibit exaggerated claims like “waterproof” on product packaging. The F.D.A’s goal with the new regulations is to prevent the most common problem with sunscreens lotions, consumer failure to use enough of them. Recently, Prevention Magazine found that only 31% of women wear sunscreen, despite the overwhelming evidence that it should be applied every day. Many of those women who skip SPF said they feel guilty about it, so much so that 69% of women lie to themselves, saying they don’t need sunscreen. Crazy, I often forget that I need to apply the sunscreen to myself every day no matter what the weather is, but which one?
The FDA is hoping to save us all a few headaches by making sure that some regulations are put into place. One, the FDA is proposing 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.
Two, the FDA is requesting 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. For sunscreen spray products, the agency requests additional data to establish effectiveness and to determine whether they present a safety concern if inhaled unintentionally. These requests arise because sprays are applied differently from other sunscreen dosage forms, such as lotions and sticks.
To help consumers select and use sunscreens appropriately, the final regulations include these additional labeling provisions:
- 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.
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.”
Please continue to use sunscreen every day no matter what the sunshine condition is outside. According to the American Academy of Dermatology, up to 80 percent of the sun’s UV rays can pass through clouds on a cloudy day. Which is why my own doctor tells me to lather it on every single day.