Statement by Alexandra Kowcz, Chief Scientist Personal Care Products Council On the Sunscreen Ban in Hawaii

Washington, D.C. – “Sunscreens play a critical role as part of a safe sun regimen in the fight against skin cancer.  We appreciate the opportunity to work with legislators in Hawaii and all interested stakeholders who came together to address the issue of sunscreens and the coral reef.  Because science serves as the foundation for everything that we do, we remain concerned that policy decisions to restrict the use of sunscreen products with FDA approved sunscreen ingredients, oxybenzone and octinoxate, are based on a limited body of scientific research from which concrete conclusions cannot be drawn.

“Coral reef degradation is an important environmental issue that we all take very seriously.  Causes for coral bleaching have been addressed by scientists around the world who state that the primary causes can be attributed to pollution, climate change and overfishing.  While we agree that coral health is of great importance, of similar great concern is the prevalence of skin cancer diagnoses and deaths. More than 10,000 people die of melanoma every year, and there are more new cases of skin cancer each year than breast, prostate, lung and colon cancers combined.  

“Daily use of sunscreens is a crucial step in the fight against skin cancer and premature skin aging.  This is why legislators in Florida, Washington, and twelve other states have expanded access to sunscreens through SUNucate, legislation that would allow students to possess and use a topical sunscreen product while on school or camp property without a physician’s note or prescription.

“The dangers of sun exposure are clear and universally recognized by public health professionals and dermatologists around the world.  When it comes to consumer health and safety, it is our hope that using sunscreen will be as much of a habit as putting on your seatbelt.”

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Statement by Beth Jonas, PhD, Chief Scientist Personal Care Products Council In Response to the Environmental Working Group’s 2017 Guide to Sunscreens

Washington, D.C. – “The cosmetics and personal care products industry is proud of the innovative sunscreen products we provide that help protect consumers from the harmful effects of the sun’s ultraviolet (UV) rays.   Sunscreen is a crucial step in the fight against skin cancer and premature skin aging. While the Environmental Working Group’s (EWG) 2017 Guide to Sunscreens helps raise awareness about the dangers of unprotected sun exposure, the report also contains several inaccuracies that can confuse consumers and be potentially harmful to public health.

“Year after year, EWG’s shopping guide contains little new information in comparison to previous reports, and their 2017 edition is no different. More importantly, the false claims made by EWG could actually keep consumers from using sunscreen altogether. For example, EWG’s assertion that there’s no evidence sunscreens prevent most skin cancers is not just false—it is irresponsible.

“Sun protection and sunscreen use are critical to preventing skin cancer and premature skin aging. According to the Skin Cancer Foundation, approximately 90 percent of non-melanoma skin cancers and 86 percent of melanomas are associated with exposure to UV radiation. Daily use of an SPF 15 or higher reduces the risk of developing melanoma by 50 percent.

“The U.S. Food & Drug Administration’s (FDA) sunscreen testing requirements are well recognized by experts and regulatory authorities across the globe. It is important to note that the FDA regulates sunscreens as over-the-counter (OTC) drugs and requires rigorous testing for sunscreen effectiveness (both SPF and Broad Spectrum). Consumers can rest assured that these reliable and credible testing methods result in sunscreens that are safe and effective in protecting them from harmful UV rays. Broad spectrum sunscreens must protect against both UVB and UVA radiation.       

“Oxybenzone, unjustly criticized every year by EWG, is one of the few FDA-approved ingredients that provides safe and effective broad-spectrum protection from UV radiation, and has been approved for use since 1978. According to the American Academy of Dermatology (AAD), available peer-reviewed scientific literature, and regulatory assessments from national and international bodies around the world, there is no link between oxybenzone in sunscreen and hormonal alterations or any other significant health issues in humans.

In addition, another ingredient called out is retinyl palmitate which is a form of vitamin A that is sometimes used in sunscreen and cosmetic products as an antioxidant and to enhance skin suppleness.  It is permitted by the FDA for use in sunscreens and several other OTC products.

“The Centers for Disease Control and Prevention (CDC), the American Academy of Dermatology (AAD), the Skin Cancer Foundation and health care professionals worldwide all emphasize the importance of sunscreen use as part of a safe sun regimen. The dangers of sun exposure are clear and universally recognized by public health professionals and dermatologists. The National Institutes of Health Report on Carcinogens identifies solar UV radiation as a ‘known human carcinogen.’ A single bad burn as a child is known to increase the skin’s susceptibility to damage and skin cancer throughout life.

“Some simple tips for sun safety include:

  •    Avoiding the sun during the peak hours of 10am-4pm
  •    Wearing sun protective clothing, including a broad-brimmed hat and UV protective sunglasses
  •    Using a broad spectrum sunscreen with an SPF of 30 or higher every day, even on cloudy days
  •    Reapplying sunscreen every two hours or immediately after swimming or sweating
  •    Seeing your health care professional every year for a skin exam

“Our goal is and continues to be to help consumers make informed decisions and use sunscreen as an important part of an overall safe sun program. Sunscreen is a crucial step in the fight against skin cancer and premature skin aging. It is our hope that using sunscreen becomes as much of a habit as using your seatbelt.”

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Statement by Beth Jonas, PhD, Chief Scientist Personal Care Products Council In Response to Consumer Reports’ 2017 Sunscreens Report

Washington, DC – “As summer approaches and consumers become more likely to consistently include sunscreens as part of a safe sun regimen, they can be confident that sunscreen products, when used in combination with other practices such as wearing sun protective clothing and avoiding the sun during peak hours, are safe and will help protect them from skin cancer, premature skin aging, and other damaging effects from the sun.

“Consumer Reports recently released a new review, where they score sunscreen products based on their own internal testing criteria.  It appears that their testing methods are not consistent with those used by the U.S. Food & Drug Administration (FDA).  Therefore, their testing methods are not the same as those required of product manufacturers to assign the SPF designation.  We recognize their shared goal to educate consumers on the importance of suns safety as well as easy steps to properly apply sunscreens.  We do, however, caution consumers that the results of the Consumer Reports testing cannot be directly compared to a label claim.

“The FDA regulates all sunscreens as over-the-counter (OTC) drugs and requires rigorous testing for sunscreen effectiveness (both SPF and Broad Spectrum).  FDA’s sunscreen testing requirements are publicly available and well recognized by experts and regulatory authorities in the U.S. as well as globally.

“All sunscreens in the United States must be tested for SPF performance using the same FDA designated clinical tests. No matter what the active ingredients, all FDA-approved sunscreens work by scattering, reflecting or absorbing UV rays.  There is no difference in efficacy between sunscreens with organic or inorganic actives; they all must be formulated to achieve their SPF label claim.

“We encourage consumers to consider the following tips for sun safety:

  • Avoid the sun during the peak hours of 10:00 am- 4 p.m.
  • Wear sun protective clothing, including a wide-brimmed hat and UV protective sunglasses
  • Use a broad spectrum sunscreen with an SPF of 30 or higher every day, even on a cloudy day
  • Reapply sunscreen every two hours or immediately after swimming or sweating
  • Visit your healthcare professional every year for a skin exam

“Our goal is to help consumers make informed decisions and use sunscreen as an important part of an overall safe sun program.  Daily use of sunscreen is a crucial step in the fight against skin cancer and premature skin aging. It is our hope that using sunscreen becomes as much of a habit as putting on your seatbelt.”  

For more information on cosmetic and personal care products, please visit www.CosmeticsInfo.org.  

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Statement by Beth Jonas, PhD, Chief Scientist Personal Care Products Council The Personal Care Products Industry Applauds Washington State Lawmakers for Advancing Public Health

Washington, D.C., – “Today, we applaud Washington State Governor Jay Inslee for signing Substitute Senate Bill No. 5404 into law, allowing and encouraging students, parents, and school personnel to apply topical sunscreen products while on school property, if the product is regulated by the U.S. Food and Drug Administration (FDA) for over-the-counter use.

“We thank Senator Ann Rivers and Representative Paul Harris for guiding the bill through the legislative process, and helping to remove barriers that have prevented children in Washington schools from using over-the-counter sunscreens.

“It is well known that skin exposed to UV radiation can be damaged, leading to premature skin aging and skin cancer. FDA, the Centers for Disease Control and Prevention (CDC), the U.S. Surgeon General, the American Academy of Dermatology (AAD), the Skin Cancer Foundation and health care professionals worldwide emphasize that daily use of sunscreens is a critical part of a safe sun regimen.  

“It’s essential to build healthy habits early on in a child’s life, such as teaching them about the importance of sunscreen and additional effective methods to reduce sun impact, like wearing protective hats and UV-blocking sunglasses, minimizing time in direct sunlight or playing in the shade, and covering exposed skin with clothing.  Starting healthy habits early leads to lifelong benefits.

“Consumer and product safety are top priorities for the cosmetics and personal care products industry, with careful and thorough scientific research and development serving as the foundation for everything we do.”

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The Personal Care Products Council and The Consumer Healthcare Products Association Statement in Response to FDA’s Final Guidance On Safety And Effectiveness Data For OTC Sunscreen Ingredients

Washington, D.C. – “The Personal Care Products Council and the Consumer Healthcare Products Association play an important role advancing the science of sunscreen safety and efficacy.  That is why our industry has worked collaboratively, via public comments and dialogues, with the U.S. Food and Drug Administration (FDA) on its Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance to ensure it reflects the best science and latest available research.

We appreciate FDA’s willingness to seek input from the industry and other stakeholders on this effort. However, we were disappointed to see that FDA’s Final Guidance did not take the industry’s comments into account, specifically around current approaches to toxicological risk assessments.  Current approaches have the potential to save significant time and resources while meeting our shared goal of protecting the public health.

“Nothing is more important than ensuring the safety of our products that are trusted and used by millions of families every day.  Our member companies continue to invest significant time and resources to provide Americans with access to a wide variety of safe and innovative sunscreens, which is a crucial step in the fight against skin cancer and premature skin aging.”

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The Personal Care Products Council and the Consumer Healthcare Products Association Released the Following Statement in Response to a JAMA Report, “Sunscreen Product Performance and Other Determinants of Consumer Preference”

“The recent JAMA publication, “Sunscreen Product Performance and Other Determinants of Consumer Preference” examines the attributes that drive consumer purchase preference as well as assesses these products against the American Academy of Dermatology (AAD) guidelines.  

“It is important to note that the U.S. Food & Drug Administration (FDA) regulates sunscreens as over-the-counter (OTC) drugs and requires rigorous testing for sunscreen effectiveness (both SPF and “Broad Spectrum”).  Perhaps more importantly, effective sunscreens are not required to share identical attributes. Sunscreens may have different levels of SPF, may be water resistant or not, and may or may not have additional cosmetics benefits.   What is clear is that consumers can rest assured that there are reliable and credible testing methods to assure that sunscreens are safe and effective in protecting them from harmful UV rays, and that there are a variety of products available to meet their needs. FDA’s sunscreen testing requirements are well-recognized by experts and regulatory authorities in the U.S. as well as globally.

“In the JAMA article, the conclusion that a significant portion of the highly rated sunscreen products did not meet the AAD criteria was largely based on these products not providing water resistance benefits.  This is not an important finding since not all effective sunscreens must be water resistant. Many consumers looking for a daily use product may prefer sunscreens without this attribute, and it is not critical for the sunscreen to be effective.  We believe that consumer choice is critical in the variety of sunscreens, as this helps assure that these products will be used.

“Consumers should not take these results to mean products are not effective as claimed; water resistance is an important benefit for sport or beach products to maintain protection during sweating or water activities.  However, as noted in the article, previous studies show that a large portion of sunscreen products are promoted as cosmetics or moisturizers, and as such, they would not contain water resistance ingredients as they are designed primarily for daily, low activity use.   Consumers should look for label statements that meet their needs, water/sweat resistance, moisturizing, etc. Compliance is a large concern and having a wide product offering, for multiple usage needs, is important to allow consumers to find a sunscreen appropriate for their needs.  

“Our goal is to help consumers make informed decisions and use sunscreen as an important part of an overall safe sun program.  Sunscreen is a crucial step in the fight against skin cancer and premature skin aging. A sunscreen not used, is not an effective sunscreen, and a good sunscreen is one people will use and reapply.”

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Statement by Beth Lange, PhD, Chief Scientist Personal Care Products Council in Response to the Environmental Working Group’s 2016 Guide to Sunscreens

“While the Environmental Working Group’s (EWG) 2016 Guide to Sunscreens helps raise awareness of the dangers of sun exposure and the importance of using sunscreen to prevent skin cancer, the report also contains inaccuracies that can confuse consumers and be potentially harmful to public health.

“This year’s shopping guide contains little new information from previous years. The claims made by EWG could keep consumers from using sunscreen altogether. Sun protection and sunscreen use are critical to preventing skin cancer and premature skin aging. According to the Skin Cancer Foundation, approximately 90 percent of non-melanoma skin cancers and 86 percent of melanomas are associated with exposure to UV radiation. Daily use of an SPF 15 or higher sunscreen reduces the risk of developing melanoma by 50 percent.

“Although the EWG report questions whether UVA rays are screened in U.S. products, broad spectrum sunscreens with SPF 15 and greater must protect against both UVB and UVA radiation.  To achieve high SPF protection values, products have to screen both UVA and UVB radiation.

“EWG cites inhalation and application concerns with spray sunscreen products, noting that the U.S. Food & Drug Administration (FDA) requested information on spray sunscreens from manufacturers. The Council and its member companies submitted significant safety and efficacy data to address FDA’s request, and scientists and dermatologists expressed their support of sprays and their desire to allow consumers access to these products. We are confident that FDA ultimately will acknowledge the continued safe use of these products and allow these sprays to remain on the market to provide consumers with additional sunscreen choices.

“Oxybenzone is one of the few FDA-approved ingredients that provides effective broad-spectrum protection from UV radiation, and has been approved for use since 1978. According to the American Academy of Dermatology (AAD), available peer-reviewed scientific literature, and regulatory assessments from national and international bodies around the world, there is no link between oxybenzone in sunscreen and hormonal alterations or any other significant health issues in humans.

“Retinyl palmitate is a form of vitamin A that is sometimes used in sunscreen products as an antioxidant and to enhance skin suppleness.

“The Centers for Disease Control and Prevention (CDC), the American Academy of Dermatology (AAD), the Skin Cancer Foundation and health care professionals around the world all emphasize the importance of sunscreen use as part of a safe sun regimen. The dangers of sun exposure are clear and universally recognized by public health professionals and dermatologists. The National Institutes of Health Report on Carcinogens identifies solar UV radiation as a ‘known human carcinogen.’ A single bad burn as a child is known to increase the skin’s susceptibility to damage and skin cancer throughout life.

“It is also important to note that the FDA regulates sunscreens as over-the-counter (OTC) drugs and requires rigorous testing for sunscreen effectiveness (both SPF and “Broad Spectrum”). Consumers can rest assured that this reliable and credible testing method results in sunscreens that are safe and effective in protecting them from harmful UV rays. FDA’s sunscreen testing requirements are well recognized by experts and regulatory authorities in the U.S. as well as globally.  

“Some simple tips for sun safety include:

  • Avoiding the sun during the peak hours of 10am-4pm
  • Wearing sun protective clothing, including a broad-brimmed hat and UV protective sunglasses
  • Using a broad spectrum sunscreen with an SPF of 15 or higher every day, even on cloudy days
  • Reapplying sunscreen every two hours or immediately after swimming or sweating
  • Seeing your health care professional every year for a skin exam

“Our goal is to help consumers make informed decisions and use sunscreen as an important part of an overall safe sun program. Sunscreen is a crucial step in the fight against skin cancer and premature skin aging. As EWG acknowledges, ‘a good sunscreen is one you’re going to use and reapply at least every two hours.’ It is our hope that using sunscreen becomes as much of a habit as using your seatbelt.”  

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Statement by Beth Lange, PhD, Chief Scientist Personal Care Products Council In Response to Consumer Reports’ “Summer Survival Guide”

“We are pleased to hear the strong message from Consumer Reports that the best sunscreen is the one a consumer is likely to use, and applaud the clear public health message that consumers should apply sunscreen adequately, to all exposed areas, and remember to reapply.  The report highlights the variety of sunscreens that are currently available to consumers. While there are many different forms (lotion, spray, etc.) and types (water resistant, fragrance free, oil free, etc.) of sunscreen available, finding one that works for an individual and proper use are key factors to protecting skin.  

“The Centers for Disease Control and Prevention (CDC), the American Academy of Dermatology (AAD), the Skin Cancer Foundation (SCF) and health care professionals around the world all emphasize the importance of sunscreen use as part of a sun safety regimen.  The dangers of sun exposure are clear and universally recognized by public health professionals and dermatologists. The National Institutes of Health Report on Carcinogens identifies solar UV radiation as a ‘known human carcinogen.’ A single bad burn as a child can increase the skin’s susceptibility to damage and skin cancer throughout life.

“It is important to note that the U.S. Food & Drug Administration (FDA) regulates sunscreens as over-the-counter (OTC) drugs and requires rigorous testing for sunscreen effectiveness (both SPF and Broad Spectrum).  Consumers can rest assured that this reliable and credible testing method results in sunscreens that are safe and effective in protecting them from harmful UV rays. FDA’s sunscreen testing requirements are well recognized by experts and regulatory authorities in the U.S. as well as globally.  Consumer Reports did their own testing of the products but did not share whether they followed the FDA guidelines required by companies.  As such, it is difficult to determine whether their results were consistent with FDA testing requirements.

“Some simple tips for sun safety include:

  • Avoiding the sun during the peak hours of 10:00 am- 4 p.m.
  • Wearing sun protective clothing, including a wide-brimmed hat and UV protective sunglasses
  • Using a broad spectrum sunscreen with an SPF of 30 or higher every day, even on a cloudy day
  • Reapplying sunscreen every two hours or immediately after swimming or sweating
  • Visiting your healthcare professional every year for a skin exam

“Our goal is to help consumers make informed decisions and use sunscreen as an important part of an overall safe sun program.  Daily use of sunscreen is a crucial step in the fight against skin cancer and premature skin aging. It is our hope that using sunscreen becomes as much of a habit as putting on your seatbelt.”  

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Statement by Personal Care Products Council and Consumer Healthcare Products Association In Response to FDA’s Draft Guidance on New Sunscreen Ingredient Data Requirements

“Today, the Personal Care Products Council and the Consumer Healthcare Products Association submitted comments in response to the U.S. Food and Drug Administration’s (FDA) Over-the-Counter Sunscreens: Safety and Effectiveness Data Draft Guidance for Industry (Draft Guidance).

“The science of ingredient safety evaluation is a highly technical, multifaceted, and rapidly evolving field.  The Draft Guidance outlines FDA’s current thinking on the kinds of data it needs before the Agency can approve a new sunscreen ingredient.  However, with few exceptions, FDA’s thinking is not reflective of the current state-of-the-art ingredient safety assessment framework recognized and used by the majority of health authorities worldwide.  

“It is because of these significant differences, and the importance of providing consumers with a wide variety of sunscreen ingredients, that we have asked FDA to hold public meetings or workshops to allow further discussion to attempt to reconcile these differences.

“Every day our industry’s research and development scientists strive to advance sunscreen formulation technology to create sunscreens that families enjoy and trust to help protect them against the harmful effects of the sun, including skin cancer and premature skin aging.  FDA must keep up with technology in order for companies to offer Americans new and innovative sunscreen products. We believe that this greater choice will encourage sunscreen use and further protect the public.

“The goal of the Sunscreen Innovation Act, passed in late 2014, is to modernize and streamline FDA’s process for reviewing sunscreen ingredients that have already been on the market in other countries for at least five years.  However, the manner in which FDA reviews sunscreen ingredient safety needs updating. FDA should use a state-of-the-art safety assessment framework that is science-based, flexible to advances in toxicological and medical science, and used by regulators and authoritative scientific bodies around the world.

“The Centers for Disease Control and Prevention (CDC), the American Academy of Dermatology (AAD), the Skin Cancer Foundation and health care professionals worldwide all emphasize that using sunscreens is a critical part of a safe sun regimen.  The dangers of sun exposure are clear and universally recognized by public health professionals and dermatologists. The National Institutes of Health Report on Carcinogens identifies solar UV radiation as a ‘known human carcinogen.’ A single bad burn in childhood doubles the risk of developing skin cancer later in life.

“Our goal is to provide Americans with access to a wide variety of safe and innovative sunscreens to use as an important part of an overall safe sun program.  Our hope is that in finalizing the Draft Guidance, FDA revises its position to reflect the current science of ingredient safety assessments.”

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Statement by Iain Davies, PhD, Senior Environmental Scientist The Personal Care Products Council, In Response to Study on Sunscreens and Coral Reefs

“Benzophenone-3 (BP-3; oxybenzone) is an important sunscreen ingredient found in many personal care products and is designed to protect people against the damaging effects of ultraviolet (UV) light. In fact, according to the American Academy of Dermatology (AAD), oxybenzone is one of the few available sunscreen ingredients that effectively protect skin from both UVA and UVB rays that can contribute to skin cancer and premature skin aging.

“A study published recently in Archives of Environmental Contamination and Toxicology suggests that this common sunscreen ingredient could be harmful to coral and contributing to the decline of reefs around the world. This conclusion is based upon research conducted under laboratory conditions, which do not accurately reflect the complexity of the natural marine environment.

“Degradation of the world’s coral reefs is a serious concern. According to the U.S. National Oceanic and Atmospheric Administration’s (NOAA) Coral Reef Conservation Program, coral reefs are threatened by an increasing array of impacts – primarily from global climate change, unsustainable fishing and other factors. There is no scientific evidence that under naturally-occurring conditions, sunscreen ingredients, which have been safely used around the world for decades, are contributing to this issue.

“Our greatest concern is that this report may result in fewer people wearing sunscreens. In fact, a recent survey by the Centers for Disease Control and Prevention (CDC) published in the Journal of the American Academy of Dermatology found that approximately 43% of men and 27% of women never use sunscreen on their faces or other exposed skin. This is particularly concerning when we consider:

  • Every year, there are more than 63,000 new cases of melanoma, the deadliest form of skin cancer, resulting in nearly 9,000 deaths;
  • Skin cancer is the most commonly diagnosed cancer in the United States, with 5 million people treated each year;
  • More than 1 out of every 3 Americans reports getting sunburned each year. Sunburn is a clear sign of overexposure to the sun’s UV rays, a major cause of skin cancer – a single bad burn in childhood doubles the risk of developing melanoma later in life.

“We all can play an important role in the fight against skin cancer. In addition to FDA, the Centers for Disease Control and Prevention (CDC), the U.S. Surgeon General, AAD, the Skin Cancer Foundation and health care professionals worldwide all emphasize that using sunscreens is a critical part of a safe sun regimen. The dangers of unprotected sun exposure are clear and universally recognized by public health professionals and dermatologists.

“As sunscreen manufacturers, our goal is to provide Americans with access to a wide variety of safe, effective and innovative sunscreens to use as an important part of an overall sun safe regimen.”

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