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FDA Insight: Episode 7 – Transcript

>> Anand Shah: Welcome back to another episode of FDA Insight. I'm Dr. Anand Shah, the Deputy Commissioner for Medical and Scientific Affairs here at the FDA. Thank you so much for joining us for another episode. It's been a scorching summer so far, so it's only appropriate that we talk about sunscreen safety this week. Joining me is Dr. Terri Michele, the Director of the Office of Non-Prescription Drugs in our FDA Drug Center. Dr. Michele, welcome to FDA Insight.

>> Terri Michele: Thanks for having me.

>> Anand Shah: Summer's underway, and Americans are spending more time outside thanks to the good weather. So, sunscreen is in high demand right now. Can you tell us a little bit more about FDA's role in ensuring the quality of sunscreen products?

>> Terri Michele: Certainly. So similar to other over-the-counter drugs, FDA regulates sunscreens to ensure that they meet safety and effectiveness standards. In February of 2019, FDA published its evaluation of the available data for over-the-counter sunscreens, and proposed measures to improve the quality, safety, and efficacy of sunscreen.

>> Anand Shah: What steps should consumers take to protect themselves from the sun?

>> Terri Michele: Well, with rising rates of skin cancer, practicing sun-safe behaviors is important for all of us. Consumers should use broad-spectrum sunscreen with an SPF of 15 or higher, even on cloudy days, and should reapply at least every two hours. Consumers should apply it more often if they're sweating or jumping in and out of the water. But while wearing sunscreen is one element of a sun-protective strategy, sun safety is more than just sunscreen. Consumers should limit time in the sun, especially between the hours of 10:00 a.m. and 2:00 p.m. when the sun's rays are the most intense. It's important to also wear clothing to cover skin exposed to the sun, such as long-sleeved shirts, pants, sunglasses, and broad-brimmed hats. And of course, if you don't have much hair, you can apply sunscreen to the top of your head or wear a hat to cover it. Finally, it's important to also seek shade whenever possible.

>> Anand Shah: You mentioned limiting sun exposure between 10:00 a.m. and 2:00 p.m. Does that mean the sun is different at various times of the day?

>> Terri Michele: Yes. The sun is stronger in the middle of the day, compared to early morning and early evening hours, increasing the risk of sunburn and other sun damage at midday. Solar intensity is also related to geographic location, with greater solar intensity occurring at the lower latitudes closer to the equator. Solar intensity also increases at higher altitudes.

>> Anand Shah: Dr. Michele, what does SPF mean?

>> Terri Michele: SPF stands for sun protection factor. This indicates the level of sunburn protection provided by the sunscreen product. There's a popular misconception that SPF relates to the time of solar exposure. This is not true, as SPF is not directly related to time of solar exposure, but to the amount of the solar exposure. So, the SPF number does not tell you how long you can stay out in the sun.

>> Anand Shah: You also mentioned selecting a broad-spectrum sunscreen. So, if I'm at CVS, Walgreens, or Walmart looking for sunscreen, what should I do?

>> Terri Michele: Well, the term "broad spectrum" means that the sunscreen protects against both UVA and UVB rays. It's important to choose a sunscreen that's both broad spectrum and SPF 15 or higher to get the best protection from the sun. In addition to protecting against sunburn, when used as directed with other sun protective measures such as those I just outlined, broad spectrum sunscreen of SPF 15 or higher also protects against skin cancer and early skin aging caused by the sun. Sunscreens that don't meet these requirements are required to carry a warning that the product does not protect against skin cancer or skin aging.

>> Anand Shah: How should sunscreen be applied, and how much should be used for the average person?

>> Terri Michele: You should apply sunscreen generously to all uncovered skin, especially in the face, the ears, the neck, the hands, and the feet. Just don't put it inside your mouth or on your eyes. An average size adult needs at least one ounce of sunscreen, which is about the amount it takes to fill a shot glass, to evenly cover the body from head to toe. If you're using a spray sunscreen, be sure to apply it in a well-ventilated area. Avoid inhalation, and keep away from fire or flame, such as a barbeque grill, until the sunscreen is completely dry. To apply it to your face, spray it first on your hands and then apply it to your face. And finally, be sure to reapply.

>> Anand Shah: Dr. Michele, how can we best protect young children? Are there sunscreens that are specific for infants and toddlers?

>> Terri Michele: Not really. For children over the age of six months, we recommend using a broad-spectrum sunscreen of SPF 15 or higher as directed on the drug facts label, the same as adults and older children. Sunscreens are not generally recommended for infants younger than six months of age. Keeping young infants in the shade and having them wear protective clothing, including a hat that protects the neck and the ears, are the best ways to protect infants from the sun.

>> Anand Shah: I've read some recent news stories suggesting some sunscreen ingredients can be absorbed through the skin and into the body. Is this a problem? Are there certain ingredients consumers should look for when purchasing sunscreen products?

>> Terri Michele: Well, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is necessarily unsafe. Rather, this finding calls for further testing to determine the safety of that ingredient for repeated use. While these data are being collected, the public should continue to use broad-spectrum sunscreens with an SPF of 15 or higher along with other sun-protective measures, because of the known benefits of sunscreen use. Active ingredients are the ingredients that are protecting your skin from the sun's harmful UV rays, while inactive ingredients are any components of the sunscreen other than the active ingredient. Both active and inactive ingredients are listed on the drug facts label.

>> Anand Shah: Many of us are using sunscreen near the pool or at the lake or beach. What is the difference between water-resistant versus waterproof sunscreen?

>> Terri Michele: Well, no sunscreens are waterproof, as all sunscreens will eventually wash off. Sunscreens that are labeled water-resistant are required to be tested according to the SPF test procedure immersion in water. Labels are required to state whether the sunscreen remained effective for 40 minutes or 80 minutes when swimming or sweating. So, if you're in the water, you should reapply sunscreen after the time period indicated on the label, either 40 minutes or 80 minutes for a water-resistant sunscreen.

>> Anand Shah: And how should we store sunscreen?

>> Terri Michele: Well, sunscreen containers should not be exposed to direct sun. So, if you're on the beach or outside the pool, protect your sunscreen by wrapping the containers in towels or keeping them in the shade. And as a fun tip, you can also put it in your cooler while you're outside in the heat for long periods of time.

>> Anand Shah: I often find tubs and sticks of sunscreen in my car and swim bag and don't always remember how long they've been there. Do sunscreens expire? And does and expiration date on the bottle mean that it's no longer good?

>> Terri Michele: Yes, sunscreens do expire. FDA regulations require all sunscreens to have an expiration date, unless the stability testing conducted by the manufacturer has shown that the product will remain stable for at least three years. That means that a sunscreen product that doesn't have an expiration date should be considered expired three years after purchase. Sunscreen that's stored in a hot environment such as a car may degrade even faster. Expired sunscreen should be discarded, because there's no assurance that they remain safe and fully effective.

>> Anand Shah: That's very helpful to know. And before we go, what else should people know about sunscreen?

>> Terri Michele: Well, the most important thing people should know about sunscreen is that they should be wearing it and reapply frequently. Again, consumers should look for sunscreens that are SPF 15 or higher and are labeled as broad-spectrum. And since no sunscreen completely blocks UV radiation, other protections such as protective clothing, sunglasses, and staying in the shade are also needed.

>> Anand Shah: With that, let's wrap up this episode of FDA Insight. Dr. Michele, thank you for taking the time to discuss this very important and topical subject.

>> Terri Michele: Thanks for inviting me on the show.

>> Anand Shah: In future episodes, we'll be discussing more topics including digital health and COVID-19 health fraud. As always, we'll be providing you insight in plain language to help you understand the products that we regulate, the issues that we face, and the processes that we follow. We hope you enjoyed this episode of FDA Insight. Please subscribe on your favorite podcast app such as Apple Podcasts, Google Play, and others. Thanks for listening.

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