Sunscreen regulations ensure sun safety

LEWISTOWN – Consumers will notice a change in sunscreen labels and lotions this year as they shop for summer vacation necessities. The changes reflect recent FDA regulations put in place to ensure product effectiveness, said Lydia Velazquez, from the FDA’s Division of Nonprescription Regulation Development.

“Our scientific understanding has grown (and) we want consumers to understand that not all sunscreens are created equal,” Valezquez said. “It is important … to read the entire label, both front and back, in order to choose the appropriate sunscreen for their needs.”

Under the new regulations, sunscreen that protects against all types of sun-induced skin damage, from UVA and UVB rays, are labeled Broad Spectrum and SPF 15 or higher. By contrast, sunscreen not labeled as Broad Spectrum or has an SPF between 2 and 14, only prevents sunburn rather than reducing the risk of skin cancer.

Testing has also determined no sunscreen is waterproof and thus labels may only read as water resistant, stating the amount of time, 40 or 80 minutes, that it’s so, said Dr. Charles Ganley, director of the FDA Office of Drug Evaluation.

“Sunscreens that claim to be water resistant must pass a test showing that they maintain their SPF rating after a person gets sweaty or goes swimming,” Ganley said. “The directions for use for all sunscreen products will state, ‘reapply every two hours.'”

The Food and Drug Administration mandated these sunscreen regulations effective as of last December, allowing manufactures time to meet the new standards and get revamped products out for the summer season.

Before regulations were put in place, there was no test used to determine the actual effectiveness of sunscreen products. Though labels may have claimed to provide a waterproof lotion with high SPF and broad spectrum ability, that was not always the case, said Dr. Stacy Klepeiss, dermatologist at Geisinger-Scenery Park.

“The danger was you had sunscreens out there stating they had certain levels of protection when they actually didn’t,” Klepeiss said. “Now that products are properly labeled, consumers can make educated choices.”

One of the things people have to recognize, however, said Dr. Laurie Cox, family medicine physician at Geisinger-Juniata, is that people also have to change their behavior when it comes to sunscreen use.

“Most people are not applying enough sunscreen or forget to reapply,” Cox said. “For example, a 150 pound person should be applying at least one ounce of sunscreen 30 minutes before going outside. The lotion should then be reapplied every two hours.”

There is also a common misconception that people with darker complexions don’t burn as much, Klepeiss said. However, that’s not the case. They’re still getting too much sun, but their bodies are not alerting them to it, she said.

“Essentially sunburn is when ultraviolet radiation causes damage to the actual cells in the skin,” Klepeiss said. “Short-term, the radiation causes blistering and peeling skin damage, but over time, it leads to cancer and skin cancer is on the rise.”

The three most common forms of skin cancer are basal cell carcinoma, squamous cell carcinoma and melanoma. Based on the most recent data from the Center for Disease Control, more than 3,440 Pennsylvania residents are diagnosed with skin cancer every year and roughly 426 people die from that disease.

“That’s why the FDA regulations are so important,” Cox said. “Consumers need to be aware of what they’re buying, and if it’s a product that reduces the risk of skin cancer or just protects from sunburn.”

Klepeiss recommends using a broad spectrum sunscreen with an SPF of 30 or higher.

For more information about sunscreen regulations, visit An example label with explanation is also available at the site.