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Sunscreens that have proven their protective ability and feature updated, more-consumer-friendly labeling are hitting store shelves, but they currently share space with older products that may not have passed muster with the Food and Drug Administration.
This mix of old and new packaging coincides with an FDA announcement that, later this year, it will review sunscreen ingredient safety and the potential approval of additional UVA-blocking agents.
In January, the agency issued its semiannual agenda for the coming year. That list included two sunscreen-related items.
The FDA said it would issue an "advance notice of proposed rulemaking" in July on how it will address sunscreen ingredient safety, which is the first step in a three-step process that culminates in a final rule.
The agency also said it would take a similar early step in the regulatory process for new ingredients manufacturers would like to add to their products.
At least six additional UVA filters are awaiting FDA approval, said Dr. Steven Q. Wang, director of dermatologic surgery and dermatology at the Memorial Sloan-Kettering Cancer Center, Basking Ridge, N.J. Currently, only two UVA-blocking agents – avobenzone and zinc oxide – are approved in the United States, but many others are available in Europe and elsewhere around the world.
Dr. Wang said he is looking forward to progress on UVA blockers; he noted that although both UVA and UVB contribute to skin cancer development, UVA penetrates deeper into the skin, contributes to more DNA damage, and plays a larger role in skin aging. A study of sunscreens from 1997 to 2009 by Dr. Wang showed that increasing numbers of products contained either avobenzone or zinc oxide, matching their claims of UVA protection.
In the late 1990s, 81% of the products surveyed claimed to protect against UVA, but only 5% actually contained a UVA blocker. By 2009, 80% of the products still made the claim, and 70% contained UVA-blocking agents. The study was published in the January issue of the journal Photochemical & Photobiological Sciences (Photochem. Photobiol. Sci. 2013;12:197-202).
Based on these findings, many of the products on the market in the past decade already met the FDA’s new criteria – announced in June 2011 – to claim protection against skin cancer, Dr. Wang said. And, clinicians and consumers should be reassured that products that meet the FDA labeling rules are effective and safe, he added.
Because they have already met the FDA’s effectiveness criteria, most products have not needed to be reformulated, said Farah Ahmed, chair of the sunscreen task force at the Personal Care Products Council.
But manufacturers have relabeled products to conform to the FDA’s rules, she said. The Council estimates that at least 4,500 products marketed in the United States claim an SPF, which subjects them to the FDA sunscreen rules. The product list includes not only sunscreens but lip balms, daily moisturizers, makeup, and any other product that contains a sunscreen component.
Products that have proved through testing that they protect against UVA and UVB radiation can claim that they are "broad spectrum" and will be labeled as SPF 15 or higher. The label also will be able to claim that the product can protect against sunburn, and, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging.
Any product not labeled as "broad spectrum" or that has an SPF value between 2 and 14 will carry a warning: "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."
Under the revised labeling, no product can claim to be waterproof or sweatproof. If a product claims to be water resistant, the product’s label must state how long a user "can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing," according to the FDA.
For more information, visit the agency’s website.
There may still be products on store shelves that have the old labeling, said Ms. Ahmed. That’s because the FDA has allowed a phase-in. Retailers also can choose to sell remaining stocks of the old products or remove them. "I think we’ll continue to see a mix of both products on the shelves," said Ms. Ahmed.
The situation creates the potential for confusion among consumers, although the FDA rules were meant to create a uniform label to help increase sun protection knowledge and the use of sun protection products.
Dr. Wang says he is telling patients to look for products that are labeled "broad spectrum" on the front, which is the best indicator that they are newly labeled and in compliance with FDA rules.
The FDA has been criticized for years for not finalizing the "monograph" – the accepted criteria or recipe – for sunscreen products. Although a final monograph is nowhere in sight, Dr. Wang said that he thought the agency had "done a reasonable job" in setting the cutoff point for products that could claim UVA protection against cancer at the accepted wavelength of 370 nm.
The FDA also plans to examine whether products labeled with an SPF greater than 50 provide any better protection than an SPF 50 sunscreen. The agency proposed in June 2011 that sunscreens with an SPF greater than 50 be labeled "SPF 50-plus," but nothing further has been issued. For now, consumers will continue to see sunscreens labeled as SPF 70, 80, or even 100.
There has been some difference of opinion on whether higher-SPF products are more beneficial. Dr. Wang said he recommends an SPF 30 product for daily use, but suggests higher SPFs for recreational activities that put users in the sun for longer periods.
The FDA also asked for more data on sunscreen-containing wipes, powders, body washes, and shampoos.
Finally, there may be some controversy down the road when the agency takes a closer look at the safety of ingredients in sun protection products. The Washington-based Environmental Working Group has criticized the safety of some of those ingredients – in particular oxybenzone and retinyl palmitate – and did so again last year in its annual review of sunscreens.
The American Academy of Dermatology refuted the group, saying that there is no evidence that these ingredients are dangerous. The AAD backs the use of a water-resistant, broad-spectrum sunscreen that protects against UVA and UVB radiation, with an SPF 30 or higher, in conjunction with limiting sun exposure and wearing sun-protective clothing.
Dr. Wang agrees that oxybenzone and retinyl palmitate appear to be safe, but he says that some manufacturers have been removing the vitamin A derivative because of the bad publicity. Oxybenzone also may be removed as newer UVA blockers are approved, he said. "But right now, we don’t have any other alternatives," he noted.
For help selecting and using sunscreens effectively, click here.
Dr. Wang disclosed that he is a consultant for L’Oreal, and that he has collaborated with researchers at Procter & Gamble, but has not received any compensation from that company.
On Twitter @aliciaault
Sunscreens that have proven their protective ability and feature updated, more-consumer-friendly labeling are hitting store shelves, but they currently share space with older products that may not have passed muster with the Food and Drug Administration.
This mix of old and new packaging coincides with an FDA announcement that, later this year, it will review sunscreen ingredient safety and the potential approval of additional UVA-blocking agents.
In January, the agency issued its semiannual agenda for the coming year. That list included two sunscreen-related items.
The FDA said it would issue an "advance notice of proposed rulemaking" in July on how it will address sunscreen ingredient safety, which is the first step in a three-step process that culminates in a final rule.
The agency also said it would take a similar early step in the regulatory process for new ingredients manufacturers would like to add to their products.
At least six additional UVA filters are awaiting FDA approval, said Dr. Steven Q. Wang, director of dermatologic surgery and dermatology at the Memorial Sloan-Kettering Cancer Center, Basking Ridge, N.J. Currently, only two UVA-blocking agents – avobenzone and zinc oxide – are approved in the United States, but many others are available in Europe and elsewhere around the world.
Dr. Wang said he is looking forward to progress on UVA blockers; he noted that although both UVA and UVB contribute to skin cancer development, UVA penetrates deeper into the skin, contributes to more DNA damage, and plays a larger role in skin aging. A study of sunscreens from 1997 to 2009 by Dr. Wang showed that increasing numbers of products contained either avobenzone or zinc oxide, matching their claims of UVA protection.
In the late 1990s, 81% of the products surveyed claimed to protect against UVA, but only 5% actually contained a UVA blocker. By 2009, 80% of the products still made the claim, and 70% contained UVA-blocking agents. The study was published in the January issue of the journal Photochemical & Photobiological Sciences (Photochem. Photobiol. Sci. 2013;12:197-202).
Based on these findings, many of the products on the market in the past decade already met the FDA’s new criteria – announced in June 2011 – to claim protection against skin cancer, Dr. Wang said. And, clinicians and consumers should be reassured that products that meet the FDA labeling rules are effective and safe, he added.
Because they have already met the FDA’s effectiveness criteria, most products have not needed to be reformulated, said Farah Ahmed, chair of the sunscreen task force at the Personal Care Products Council.
But manufacturers have relabeled products to conform to the FDA’s rules, she said. The Council estimates that at least 4,500 products marketed in the United States claim an SPF, which subjects them to the FDA sunscreen rules. The product list includes not only sunscreens but lip balms, daily moisturizers, makeup, and any other product that contains a sunscreen component.
Products that have proved through testing that they protect against UVA and UVB radiation can claim that they are "broad spectrum" and will be labeled as SPF 15 or higher. The label also will be able to claim that the product can protect against sunburn, and, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging.
Any product not labeled as "broad spectrum" or that has an SPF value between 2 and 14 will carry a warning: "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."
Under the revised labeling, no product can claim to be waterproof or sweatproof. If a product claims to be water resistant, the product’s label must state how long a user "can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing," according to the FDA.
For more information, visit the agency’s website.
There may still be products on store shelves that have the old labeling, said Ms. Ahmed. That’s because the FDA has allowed a phase-in. Retailers also can choose to sell remaining stocks of the old products or remove them. "I think we’ll continue to see a mix of both products on the shelves," said Ms. Ahmed.
The situation creates the potential for confusion among consumers, although the FDA rules were meant to create a uniform label to help increase sun protection knowledge and the use of sun protection products.
Dr. Wang says he is telling patients to look for products that are labeled "broad spectrum" on the front, which is the best indicator that they are newly labeled and in compliance with FDA rules.
The FDA has been criticized for years for not finalizing the "monograph" – the accepted criteria or recipe – for sunscreen products. Although a final monograph is nowhere in sight, Dr. Wang said that he thought the agency had "done a reasonable job" in setting the cutoff point for products that could claim UVA protection against cancer at the accepted wavelength of 370 nm.
The FDA also plans to examine whether products labeled with an SPF greater than 50 provide any better protection than an SPF 50 sunscreen. The agency proposed in June 2011 that sunscreens with an SPF greater than 50 be labeled "SPF 50-plus," but nothing further has been issued. For now, consumers will continue to see sunscreens labeled as SPF 70, 80, or even 100.
There has been some difference of opinion on whether higher-SPF products are more beneficial. Dr. Wang said he recommends an SPF 30 product for daily use, but suggests higher SPFs for recreational activities that put users in the sun for longer periods.
The FDA also asked for more data on sunscreen-containing wipes, powders, body washes, and shampoos.
Finally, there may be some controversy down the road when the agency takes a closer look at the safety of ingredients in sun protection products. The Washington-based Environmental Working Group has criticized the safety of some of those ingredients – in particular oxybenzone and retinyl palmitate – and did so again last year in its annual review of sunscreens.
The American Academy of Dermatology refuted the group, saying that there is no evidence that these ingredients are dangerous. The AAD backs the use of a water-resistant, broad-spectrum sunscreen that protects against UVA and UVB radiation, with an SPF 30 or higher, in conjunction with limiting sun exposure and wearing sun-protective clothing.
Dr. Wang agrees that oxybenzone and retinyl palmitate appear to be safe, but he says that some manufacturers have been removing the vitamin A derivative because of the bad publicity. Oxybenzone also may be removed as newer UVA blockers are approved, he said. "But right now, we don’t have any other alternatives," he noted.
For help selecting and using sunscreens effectively, click here.
Dr. Wang disclosed that he is a consultant for L’Oreal, and that he has collaborated with researchers at Procter & Gamble, but has not received any compensation from that company.
On Twitter @aliciaault
Sunscreens that have proven their protective ability and feature updated, more-consumer-friendly labeling are hitting store shelves, but they currently share space with older products that may not have passed muster with the Food and Drug Administration.
This mix of old and new packaging coincides with an FDA announcement that, later this year, it will review sunscreen ingredient safety and the potential approval of additional UVA-blocking agents.
In January, the agency issued its semiannual agenda for the coming year. That list included two sunscreen-related items.
The FDA said it would issue an "advance notice of proposed rulemaking" in July on how it will address sunscreen ingredient safety, which is the first step in a three-step process that culminates in a final rule.
The agency also said it would take a similar early step in the regulatory process for new ingredients manufacturers would like to add to their products.
At least six additional UVA filters are awaiting FDA approval, said Dr. Steven Q. Wang, director of dermatologic surgery and dermatology at the Memorial Sloan-Kettering Cancer Center, Basking Ridge, N.J. Currently, only two UVA-blocking agents – avobenzone and zinc oxide – are approved in the United States, but many others are available in Europe and elsewhere around the world.
Dr. Wang said he is looking forward to progress on UVA blockers; he noted that although both UVA and UVB contribute to skin cancer development, UVA penetrates deeper into the skin, contributes to more DNA damage, and plays a larger role in skin aging. A study of sunscreens from 1997 to 2009 by Dr. Wang showed that increasing numbers of products contained either avobenzone or zinc oxide, matching their claims of UVA protection.
In the late 1990s, 81% of the products surveyed claimed to protect against UVA, but only 5% actually contained a UVA blocker. By 2009, 80% of the products still made the claim, and 70% contained UVA-blocking agents. The study was published in the January issue of the journal Photochemical & Photobiological Sciences (Photochem. Photobiol. Sci. 2013;12:197-202).
Based on these findings, many of the products on the market in the past decade already met the FDA’s new criteria – announced in June 2011 – to claim protection against skin cancer, Dr. Wang said. And, clinicians and consumers should be reassured that products that meet the FDA labeling rules are effective and safe, he added.
Because they have already met the FDA’s effectiveness criteria, most products have not needed to be reformulated, said Farah Ahmed, chair of the sunscreen task force at the Personal Care Products Council.
But manufacturers have relabeled products to conform to the FDA’s rules, she said. The Council estimates that at least 4,500 products marketed in the United States claim an SPF, which subjects them to the FDA sunscreen rules. The product list includes not only sunscreens but lip balms, daily moisturizers, makeup, and any other product that contains a sunscreen component.
Products that have proved through testing that they protect against UVA and UVB radiation can claim that they are "broad spectrum" and will be labeled as SPF 15 or higher. The label also will be able to claim that the product can protect against sunburn, and, if used as directed with other sun protection measures, can reduce the risk of skin cancer and early skin aging.
Any product not labeled as "broad spectrum" or that has an SPF value between 2 and 14 will carry a warning: "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."
Under the revised labeling, no product can claim to be waterproof or sweatproof. If a product claims to be water resistant, the product’s label must state how long a user "can expect to get the declared SPF level of protection while swimming or sweating, based on standard testing," according to the FDA.
For more information, visit the agency’s website.
There may still be products on store shelves that have the old labeling, said Ms. Ahmed. That’s because the FDA has allowed a phase-in. Retailers also can choose to sell remaining stocks of the old products or remove them. "I think we’ll continue to see a mix of both products on the shelves," said Ms. Ahmed.
The situation creates the potential for confusion among consumers, although the FDA rules were meant to create a uniform label to help increase sun protection knowledge and the use of sun protection products.
Dr. Wang says he is telling patients to look for products that are labeled "broad spectrum" on the front, which is the best indicator that they are newly labeled and in compliance with FDA rules.
The FDA has been criticized for years for not finalizing the "monograph" – the accepted criteria or recipe – for sunscreen products. Although a final monograph is nowhere in sight, Dr. Wang said that he thought the agency had "done a reasonable job" in setting the cutoff point for products that could claim UVA protection against cancer at the accepted wavelength of 370 nm.
The FDA also plans to examine whether products labeled with an SPF greater than 50 provide any better protection than an SPF 50 sunscreen. The agency proposed in June 2011 that sunscreens with an SPF greater than 50 be labeled "SPF 50-plus," but nothing further has been issued. For now, consumers will continue to see sunscreens labeled as SPF 70, 80, or even 100.
There has been some difference of opinion on whether higher-SPF products are more beneficial. Dr. Wang said he recommends an SPF 30 product for daily use, but suggests higher SPFs for recreational activities that put users in the sun for longer periods.
The FDA also asked for more data on sunscreen-containing wipes, powders, body washes, and shampoos.
Finally, there may be some controversy down the road when the agency takes a closer look at the safety of ingredients in sun protection products. The Washington-based Environmental Working Group has criticized the safety of some of those ingredients – in particular oxybenzone and retinyl palmitate – and did so again last year in its annual review of sunscreens.
The American Academy of Dermatology refuted the group, saying that there is no evidence that these ingredients are dangerous. The AAD backs the use of a water-resistant, broad-spectrum sunscreen that protects against UVA and UVB radiation, with an SPF 30 or higher, in conjunction with limiting sun exposure and wearing sun-protective clothing.
Dr. Wang agrees that oxybenzone and retinyl palmitate appear to be safe, but he says that some manufacturers have been removing the vitamin A derivative because of the bad publicity. Oxybenzone also may be removed as newer UVA blockers are approved, he said. "But right now, we don’t have any other alternatives," he noted.
For help selecting and using sunscreens effectively, click here.
Dr. Wang disclosed that he is a consultant for L’Oreal, and that he has collaborated with researchers at Procter & Gamble, but has not received any compensation from that company.
On Twitter @aliciaault
