The federal government may shake up your favorite sunscreen.
Based on the latest scientific data, the US Food and Drug Administration (FDA) suggested new base It would update regulations for most sunscreen products sold in America.
Announced February 21, 2019, the proposal addresses SPF levels, product types, label requirements, and safety of active ingredients.
FDA Commissioner Scott Gottlieb, MD, recognized that the effort was taking a long time, saying that some requirements for sunscreen products haven’t been updated in decades.
Dr. said. a permit. “Our proposal would improve the quality, safety, and effectiveness of sunscreens that Americans use every day.”
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What sunscreen ingredients are being questioned about their safety?
Of the 16 sunscreen ingredients currently available for use, only two — zinc oxide and titanium dioxide — have been identified as “generally recognized as safe and effective,” or GRASE.
However, two other ingredients (PABA, para-aminobenzoic acid, and trolamine salicylate) are not considered safe or effective under the proposed new FDA rule.
“PABA has been shown to absorb UV light, but there is some early data to suggest that it may not prevent cellular damage caused by UV light,” says Irum Elias, MD, a dermatologist in King of Prussia, Pennsylvania, M.D. in Pediatric Dermatology Society. “It’s also been implicated in cases of contact dermatitis,” a common type of eczema characterized by dermatitis.
Dr. Elias adds that trolamine may be able to combine with nitrites to potentially contribute to the development of cancer, and both chemicals may be endocrine disruptors.
Regarding the remaining 12 chemicals, the Food and Drug Administration notes that more data is needed to determine their safety and efficacy. These ingredients are synoxate, deoxybenzone, insulazole, homosalate, myradite, octinoxate, octisalate, octocrylene, O-pademate, solezobenzone, oxybenzone and avobenzone.
Seemal Desai, MD, a dermatologist in Plano, Texas, and board member of American Academy of Dermatology.
Because the research is uncertain, stresses Michelle S. Green, MD, a dermatologist at Lenox Hill Hospital in New York City, said she would not advise her patients to get rid of their current sunblock. “The takeaway is that there is more unknown information than is known in the FDA statement,” says Dr. Green. “If you want to be extra careful, just look for a sunscreen that contains zinc oxide or titanium oxide.”
Currently, residents of Canada, Australia, Japan, and countries in Europe have access to different sunscreens than people in the United States, and these products may do a better job at preventing skin cancer, according to a report in Bloomberg Business. Some dermatologists see this move by the Food and Drug Administration as a step toward accessing more and better sunscreens.
“We want to make sure Americans can get access to new, advanced UV-filtering ingredients, many of which are available in other countries but cannot be used here because they haven’t gone through the FDA process,” says Dr. Desai.
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How a suggestion SPF requirement might give you more sun protection
Unprotected exposure to the sun’s UV rays is a major risk factor for skin cancer. The American Academy of Dermatology Association (AADA) recommends a comprehensive sun protection plan that includes seeking shade; wear protective clothing, including a lightweight long-sleeved shirt and pants, a wide-brimmed hat, and sunglasses; Generously apply a broad-spectrum, waterproof sunscreen to exposed skin. Broad spectrum means that the block protects against UVA (long wave) and UVB (short wave) rays.
AADA also suggests using products with an SPF of 30 or higher. A new FDA proposal recommends raising the maximum value of the sun protection factor (SPF) on sunscreen labels from SPF 50+ to SPF 60+.
“I tell my patients that the higher the SPF, the better,” Desai says. “Research shows that SPF 30 blocks about 98 percent of the rays, so anything higher will only get a gradual increase. I still think, though, that you might only block 1 percent of the rays with an SPF Higher than an SPF, if that 1 percent gives you more protection, why not do it?”
What sunscreen products will be affected by the rule?
The new proposal outlines the types of sun protection products that are generally considered safe and effective, such as sprays, oils, lotions, creams, gels, butters, pastes, ointments and sticks.
The FDA is still looking to evaluate products that contain sunscreen ingredients, including wipes, washcloths, body wash, and shampoo. The suggestion also advises that combinations of sunscreen and insect repellent should not be considered safe and effective.
Another recommendation is to improve labeling by providing basic information on active ingredients, alerting the consumer regarding skin cancer, and skin aging information for sunscreens that have not been shown to help prevent skin cancer. The labels also indicate sun protection factor (SPF), broad spectrum, and water resistance.
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Why did the proposed rule come so long ago
In 2014, Sunscreen Innovation Act To expedite the review process for the safety and efficacy of over-the-counter sunscreen active ingredients. But the change took some time.
“When the Food and Drug Administration announced that it was changing and regulating more safety of nonprescription sunscreens and their active ingredients, it was a huge hoopla,” Green says. And then nothing happened. This proposed regulation has been coming in for years. “
However, the final rule will not be due until November 2019. Currently, the FDA is conducting the review process and accepting comments on the proposed regulation.
“So for consumers, there is no need to worry and no need to panic,” Desai says. “If you have questions, get an expert opinion from a board-certified dermatologist, especially if you have changing skin lesions, regarding moles, new growths, sunburn, and questions about sunscreen.”