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New FDA Guidelines on Sunscreen: How to Best Protect Your Skin

Share on PinterestExperts advise applying sunscreen every two hours you’re outside. Getty Images

People planning on spending a lot of time in the summer sun might want to pay attention to the new suggested regulations for sunscreens.

Earlier this year, the Food and Drug Administration (FDA) announced a proposed rule that would update regulation requirements for most sunscreen products sold in the United States.

The goal was to update over-the-counter (OTC), nonprescription sunscreens that don’t already have FDA approval with the latest scientific research to ensure access to the most effective methods of skin protection.

The announcement was significant because FDA guidelines for sunscreens haven’t been updated in several decades.

“Today’s action is an important step in the FDA’s ongoing efforts to take into account modern science to ensure the safety and effectiveness of sunscreens,” Dr. Scott Gottlieb, the FDA commissioner, said in a February press release. “The proposal we’ve put forward would improve quality, safety, and efficacy of the sunscreens Americans use every day. We will continue to work with industry, consumers, and public health stakeholders to ensure that we’re striking the right balance.”

What are the new guidelines?

Exactly what are the new sunscreen guidelines?

The proposal focuses on ensuring sunscreens are officially designated as being generally recognized as safe and effective (GRASE) with the two sun-blocking ingredients — zinc oxide and titanium dioxide — deemed sufficiently safe for use.

The FDA also proposed that the maximum sun protection factor (SPF) level increase from 50+ to 60+ in order to offer the best protection. Sunscreens that have an SPF of 15 or higher are required to have broad-spectrum protection.

Sprays, oils, lotions, creams, gels, butters, pastes, ointments, and sticks are official FDA-sanctioned dosage forms for sunscreens. Right now, powders are being proposed to be eligible for inclusion, but the release stipulates that additional data is needed. And it’s suggested that sunscreen product labels be improved, too.

The FDA states that labels should be clearer for consumers, identifying information such as active ingredients on the front of the package to make sunscreens more like other OTC drugs.

It’s also suggested that these labels include a notification of a skin-cancer and skin-aging alert for products that haven’t been proven to prevent skin cancer.

Why sunscreen is important

Sun protection is important.

Skin cancer is the most common form of cancer nationwide, with 1.6 million new cases reported in 2015. For every 100,000 people, 22 new melanomas of the skin were reported, with two of the 22 cases resulting in death, the Centers for Disease Control and Prevention reports.

There are three different types of skin cancer: basal cell carcinoma, squamous cell carcinoma, and melanoma.

The most common, basal cell carcinoma, doesn’t commonly spread to other parts of the body, but it’s still recommended to be removed.

Squamous cell carcinoma can spread quickly and be cured when caught early on.

The deadliest type of skin cancer is melanoma, which can be difficult to treat if not caught early, the Mayo Clinic reports.

Short of avoiding the sun, sunscreen is the best tool you can use to protect yourself from skin cancer.

Dr. William W. Huang, MD, an associate professor and residency program director at Wake Forest School of Medicine in North Carolina, told Healthline that sunscreen should generally be applied about 30 minutes before sun exposure and reapplied at least every two hours once you’re outside.

“People are getting better about applying sunscreen but can be forgetful about reapplying sunscreen,” Huang said. “Although the face is a sensitive area of the body, it is prone to UV (ultraviolet) damage and the development of skin cancer due to UV exposures over a lifetime. So, be liberal with the amount of sunscreen you apply.”

Ways to protect yourself

Dr. Amy Kassouf, MD, a dermatologist at the Cleveland Clinic in Ohio, told Healthline she likes to combine sunblock with sun-protective clothing when she heads outside so she doesn’t have to worry about repeated application to sensitive areas such as the face, hands, and feet.

Oftentimes, even with the best intentions, people tend to overlook sensitive parts like the eyelids, lips, and ears when putting on sunscreen.

Kassouf said that when it comes to the eyelids, for example, “100 percent ultraviolet (UV)-blocking sunglasses with wider side pieces” are usually effective to protect the temples.

She also advises using sunscreen sticks on the forehead instead of creams or lotions, which can easily drip into your eyes and cause irritation once you begin to sweat.

What about sunscreen sprays? Kassouf says they don’t offer reliable consistent coverage and advises using sunscreen in another form for better results.

Another sensitive area people often miss with sunscreen is the lips.

“Most of our lip products do not contain an SPF and often can increase the sun’s penetration into this area with the pigments and emollients that they do contain,” Kassouf said. “The lower lip is particularly sensitive and so sun protection in your lip products when outdoors is essential.”

Huang added that people with sensitive skin might want to look for sunscreens that contain physical blockers such as zinc oxide and titanium dioxide instead of chemical absorbers that seep into the skin.

“Sunscreen should be stored in a cool, dry place because heat can gradually break down sunscreen. Also check the expiration date on sunscreen products because they don’t last forever,” he said.

Dr. Jennifer Lucas, MD, a dermatologist at Cleveland Clinic, said people should get into the habit of applying sunscreen every day, even when it’s cloudy outside.

Dr. Jennifer Stein, MD, a dermatologist at NYU Langone Health in New York City, also pointed out that people sometimes get serious burns on their skin near the edge of their clothing.

She said this is because people might not want to get sunscreen on their bathing suit. When it comes to this, she said put aside concerns of getting a slight smudge on your clothing to be sure to protect your skin near these vulnerable areas.

“There are a lot of good products to use. The best products are the ones that actually get used, so it’s important to find something you feel comfortable with and putting it everywhere you will need it — in your car, golf bag, workout bag,” Kassouf said. “Also, mixing it up with sun-protective clothing, hats, sunglasses, avoidance of midday sun, shade, and other strategies works the best overall.”

What to look for in sunscreen

With the new proposed FDA guidelines, what should you look for when buying a good sunscreen?

Stein said you should always use sunscreen with an SPF of at least 30 and that has “broad-spectrum” on the label, meaning it protects against both ultraviolet A (UVA) and ultraviolet B (UVB) rays.

“Be sure to pick a sunscreen with a smell and feel that you’ll want to use. It doesn’t matter how effective your sunscreen is if you never take it out and use it,” she said.

Huang said that besides skin cancer risk, another incentive for buying sunscreen is because UV radiation can prematurely age your skin.

Huang echoed Stein that you should go for a broad-spectrum sunscreen that has a high SPF. An SPF of 30 to 50 works well for everyday use, but Huang suggested an SPF of 50+ when you plan on being outside for a long time.

“If you’re particularly active or will be sweating or swimming, you may want to find a sunscreen that is sweat-resistant or water-resistant,” he said.

“Finding the right sunscreen can be a little like finding the right toothpaste,” Huang said. “Once you find one with the right protection, it can ultimately come down to personal preference.”

Kassouf said that down the line, innovations in sunscreen research could lead to an even more diverse array of products available.

“There may even be oral supplements that help decrease sun sensitivity, but medications and some supplements may increase sun sensitivity, such as antibiotics and diuretics, so extra caution is needed,” she said.

When it comes down to it, you can never be too careful out in the sun.

Huang said that while a lot of attention is directed at skin protection during the warmer months of the year, skin cancer risk persists year-round.

“People should wear sunscreen 365 days a year — not only on sunny, hot days,” he said. “Even on an overcast day, 70 to 80 percent of UV radiation can come through.”

The bottom line

In February, the FDA released a proposed ruling for new sunscreen guidelines.

This was the first big shift in sunscreen guidelines in several decades.

The FDA suggested a range of rules, from clearer package labels to safer materials used to make sunscreens to higher maximum SPF levels made available on the market.

Skin cancer is the most common form of cancer in the United States and leads to more than 1 million new cases of cancer each year.

Dermatologists stress to protect sensitive and overlooked areas like the ears, lips, eyelids, and edges around clothing.

Opt for a sunscreen with an SPF of 30 or higher when heading outside, and apply about a half hour before sun exposure.

Doctors urge people to reapply sunscreen every two hours you spend outside, and switch to a higher SPF of 50 or more if you plan on spending long stretches of time in the sun.

New FDA Guidelines on Sunscreen: How to Best Protect Your Skin




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The draft guidance entitled " Enforcement Policy OTC Sunscreen Drug Products Marketed Without an Approved Application" (PDF - 83KB), is also available. Between then and now, sunscreen manufacturers did not have many rules regarding marketing, labeling, and making certain claims about their products functionality and efficacy. However, current data questions whether or not this type of application is as effective as directly applied thicker creams and lotions. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. The product is then labeled with the appropriate SPF value indicating the amount of sunburn protection provided by the product. People often and mistakenly believe that using a product containing a higher SPF means that they can stay out in the sun longer and not have to reapply as often as lower SPFs.


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On June generic cialis discount code 14, 2011 the.S. Food and Drug Administration announced that starting in the summer of 2012, sunscreen products will have to undergo different tests to determine how they will be allowed to be labeled and marketed. Just in time for summer, new FDA guidelines are out that clarify what the labeling on sunscreen packages actual means and what kind of protections a sunscreen will offer. New FDA Guidelines on Sunscreen: How to Best Protect Your Skin This Summer. Healthline - Brian Mastroianni. FDAs Sunscreen Guidelines: The Food and Drug Authority (FDA) of the country has decided to introduce new guidelines for the sale of sunscreen, how to apply and store it and how to read the labels and what they mean. We keep being asked about the impact of the Federal Drug Administrations (FDAs) recently released (in 2011) sunscreen guidelines, so heres a quick overview.

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