Statement by the Personal Care Products Council and the Consumer Healthcare Products Association on the FDA’s Proposed Administrative Order for Sunscreens


FOR IMMEDIATE RELEASE

CONTACTS:       

Lisa Powers, (202) 297-1232, powersl@personalcarecouncil.org
Mike Tringale, (202) 429-3520, mtringale@chpa.org

Washington, D.C. – “Sunscreens are a crucial and well-recognized tool in the fight against skin cancer. The dangers of excessive sun exposure are clear and universally recognized by public health professionals, including prominent dermatologists. As part of the revised regulation of sunscreens, the U.S. Food and Drug Administration (FDA) issued a proposed Administrative Order today, largely mirroring provisions made in its 2019 Tentative Final Monograph (TFM). These include revisions and updates related to maximum sun protection factor (SPF) values, active ingredients, broad spectrum requirements and product labeling.

“As part of today’s proposed Administrative Order, the FDA is reiterating its request for additional data for some sunscreen filters currently approved in the U.S. to further evaluate their status as generally recognized as safe and effective (GRASE). Importantly, sunscreens made with these ingredients are not considered unsafe by the FDA and will remain on the market to be used as part of consumers’ sun-safe practices while more data are collected. Not all of these ultraviolet (UV) filters are used in formulations marketed today.

“In the U.S., sunscreen products are regulated by the FDA as non-prescription, over-the-counter (OTC) drug products. Our industry has long supported OTC monograph reform, and our member companies remain committed to working with the FDA to further demonstrate the safety of UV filters in sunscreens – avobenzone, oxybenzone, octocrylene, octisalate, octinoxate, homosalate, ensulizole and meradimate. These filters are approved globally in Europe and other regions around the world and have been used in formulations in the U.S. for decades.

“Numerous nonprofit health organizations and government agencies worldwide, including the U.S. Centers for Disease Control and Prevention (CDC), American Academy of Dermatology (AAD) and Skin Cancer Foundation, recommend continuing to use sunscreens as part of a safe-sun regimen. The FDA noted in its announcement of the proposed Order, ‘Sun safety is important for everyone, regardless of your skin tone. Americans can reduce risks from sun exposure with continued use of sun protection measures including broad spectrum sunscreen.’ Ensuring consumers have access to sunscreen products containing UVA protection is an important contribution to the FDA’s public health mission. 

“The personal care and consumer healthcare products industries have a long history of working to improve the well-being of the people who trust and rely on our products every day. Our goal is to provide consumers with access to a wide variety of safe, effective and innovative sunscreens to meet the differing needs of individuals and their families. Sunscreen products protect consumers from harmful UV rays that can cause premature aging and skin cancer. We hope that using sunscreen becomes as much of a health habit as putting on your seatbelt.”  

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About the Personal Care Products Council
Founded in 1894, the Personal Care Products Council (PCPC) is the voice and advocate for 600 member companies representing the $450 billion global cosmetics and personal care products industry. PCPC’s members represent approximately 90% of the U.S. beauty industry and are some of the most beloved and trusted brands in beauty and personal care today. As manufacturers, distributers and suppliers of a diverse range of products millions of consumers rely on every day – from sunscreens, toothpaste and shampoo to moisturizer, makeup and fragrance – PCPC’s member companies are global leaders committed to safety, quality and innovation. For more information on cosmetics and personal care products, please visit www.CosmeticsInfo.org.

About the Consumer Healthcare Products Association
The Consumer Healthcare Products Association (CHPA), founded in 1881, is the national trade association representing the leading manufacturers and marketers of consumer healthcare products, including over-the-counter (OTC) medicines, dietary supplements, and consumer medical devices. CHPA is committed to empowering self-care by ensuring that Americans have access to products they can count on to be reliable, affordable, and convenient, while also delivering new and better ways to get and stay healthy. Visit www.chpa.org.

Statement by Alexandra Kowcz, Chief Scientist, Personal Care Products Council, Addressing a Recent Paper on Potential Presence of Benzophenone in Sunscreens Containing Octocrylene


FOR IMMEDIATE RELEASE 

CONTACTS:       

Lisa Powers, powersl@personalcarecouncil.org, (202) 297-1232
Stefanie Harrington, harringtons@personalcarecouncil.org, (202) 615-6558
Jamie Kurke, kurkej@personalcarecouncil.org, (202) 258-5285

Washington, D.C. – “Sunscreens on the market today are backed by decades of safe use to help adults and children guard against the dangers of sun exposure, playing a critical role in the fight against skin cancer. The recently published research paper, ‘Benzophenone Accumulates Over Time from the Degradation of Octocrylene in Commercial Sunscreen Products’[1] perpetuates misinformation and needlessly misleads and scares consumers about the safety of sunscreen products, potentially discouraging sunscreen use and putting consumers’ health at risk. 

“The study claims the sunscreen ingredient octocrylene can naturally degrade into the chemical benzophenone and increase in concentration as sunscreen products age, suggesting a potential risk to human health. However, global regulatory agencies have concluded that octocrylene is safe as a UV-filter in products such as sunscreen cream and lotion, sunscreen pump spray, face creams, hand cream and lip products. It is important to note that the report’s authors concluded that additional research should be conducted.

“Octocrylene is a chemical sun filter that provides balanced UVB and UVA protection. It remains stable during sun exposure, provides better water resistance and global regulatory bodies permit its use.  Octocrylene has been approved for use as an active sunscreen ingredient by the U.S. Food and Drug Administration (FDA) for decades. While the FDA has asked for additional data on a number of sunscreen active ingredients (including octocrylene), the agency has clearly stated that this request does not indicate that these ingredients are unsafe. In addition, given the recognized public health benefits of sunscreen use, FDA urged consumers to continue to use sunscreen in conjunction with other sun-protection measures as FDA gathers additional scientific information. PCPC and its member companies have been actively working with the FDA to provide data that will allow an updated safety assessment of octocrylene.

“PCPC and its member companies support the U.S. National Academies of Sciences, Engineering and Medicine’s efforts to review the state of science on currently marketed sunscreen ingredients, their fate and effects in aquatic environments, and the potential public health implications associated with changes to the use of sunscreens.

‘The European Union (EU) includes octocrylene in Annex VI of the Cosmetic Products Regulation (No 1223/2009) as an approved UV sunscreen filter. The EU’s Scientific Committee on Consumer Safety (SCCS) concluded octocrylene is safe in sunscreen products as recently as March 31, 2021.

“The FDA, Centers for Disease Control and Prevention (CDC), U.S. Surgeon General, American Academy of Dermatology, Skin Cancer Foundation, and health professionals worldwide consistently advocate for the use of broad-spectrum sunscreens as part of a safe-sun regimen. Nonprofit health organizations and government agencies recommend using sunscreens as part of a safe-sun regimen to prevent skin cancer. CDC’s Sun Safety recommendations note the importance of daily sunscreen use to help prevent most skin cancers, even on cloudy and overcast days.

“As sunscreen manufactures, our goal is to provide our consumers with access to a wide variety of safe, effective and innovative sunscreens so they can make informed decisions. Sunscreen is an important part of an overall safe sun program.  It is our hope that using sunscreen becomes as much of a habit as putting on your seatbelt.” 

[1] “Benzophenone Accumulates over Time from the Degradation of Octocrylene in Commercial Sunscreen Products” Chemical Research in Toxicology: https://dx.doi.org/10.1021/acs.chemrestox.0c00461

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For more information on cosmetics and personal care products, please visit www.Cosmeticsinfo.org.

Founded in 1894, the Personal Care Products Council (PCPC) is the voice and advocate for 600 member companies representing the $450 billion global cosmetics and personal care products industry. PCPC’s members represent approximately 90% of the U.S. beauty industry and are some of the most beloved and trusted brands in beauty and personal care today. As manufacturers, distributers and suppliers of a diverse range of products millions of consumers rely on every day – from sunscreens, toothpaste and shampoo to moisturizer, makeup and fragrance – PCPC’s member companies are global leaders committed to safety, quality and innovation. 

Statement by the Personal Care Products Council on Benzene and Sunscreens


FOR IMMEDIATE RELEASE

CONTACTS:     

Lisa Powers, powersl@personalcarecouncil.org, (202) 297-1232
Stefanie Harrington, harringtons@personalcarecouncil.org, (202) 615-6558
Jamie Kurke, kurkej@personalcarecouncil.org, (202) 258-5285

Washington, D.C. – “The Personal Care Products Council (PCPC) and its member companies are firmly committed to ensuring consumers have access to cosmetics and personal care products with ingredients that have been thoroughly tested for safety and follow the requirements of the law. There is nothing more important than safety. If our consumers can’t believe in a product or rely on it to do what it says, then nothing else matters. We are aware of the study reporting the presence of benzene in some of the sunscreen products tested.

“Benzene is not an intentionally added ingredient in sunscreen products, however, the U.S. Food and Drug Administration (FDA), as well as product manufacturers, are aware that benzene may be found in food and drugs at very low levels. FDA offers guidance on the level of residual solvents as a companion document for the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). PCPC strongly supports FDA’s guidance and activities in monitoring for conformance to these recommendations.  

“Sunscreens on the market today are backed by decades of safe use to help adults and children guard against the dangers of sun exposure. The FDA, Centers for Disease Control and Prevention (CDC), U.S. Surgeon General, American Academy of Dermatology, Skin Cancer Foundation, and health professionals worldwide consistently advocate for the use of broad-spectrum sunscreens as part of a safe-sun regimen. These products play a critical role in the fight against skin cancer.

“Nonprofit health organizations and government agencies recommend using sunscreens as part of a safe-sun regimen. CDC’s Sun Safety recommendations note the importance of daily sunscreen use to help prevent most skin cancers, even on cloudy and overcast days.

“As sunscreen manufactures, our goal is to provide our consumers with access to a wide variety of safe, effective and innovative sunscreens so they can make informed decisions. Sunscreen is an important part of an overall safe-sun program. It is our hope that using sunscreen becomes as much of a habit as putting on your seatbelt.” 

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Founded in 1894, the Personal Care Products Council (PCPC) is the voice and advocate for 600 member companies representing the $450 billion global cosmetics and personal care products industry. PCPC’s members represent approximately 90% of the U.S. beauty industry and are some of the most beloved and trusted brands in beauty and personal care today. As the manufacturers, distributers and suppliers of a diverse range of products millions of consumers rely on every day – from sunscreens, toothpaste and shampoo to moisturizer, makeup and fragrance – PCPC’s member companies are global leaders committed to product safety, quality and innovation. For more information on cosmetics and personal care products and their ingredients, please visit www.CosmeticsInfo.org.

 

Sun Safety and Wellness After COVID


By Carl D’Ruiz
Senior Manager, NA Personal Care Regulatory Affairs
DSM Nutritional Products LLC

Summer unofficially kicks off Memorial Day weekend, and many people will soon be spending more time outdoors, in the water and traveling to sunny destinations. As more people receive COVID-19 vaccinations and restrictions are lifted, it feels more exciting than ever to be outside enjoying the sun and summer season. But, it’s also critically important to protect your skin from over-exposure to the sun. And health experts worldwide agree that sun protection helps prevent sunburns, premature skin aging and skin cancer.

Skin Cancer Facts

Over-exposure to ultraviolet (UV) light – invisible sun rays that can damage skin cells – causes most skin cancers. In the Unites States alone, nearly 5 million people are treated for skin cancer each year. Although those with lighter skin are at higher risk, anyone can get skin cancer. People with darker skin may often be diagnosed with skin cancer at a later stage, making it more difficult to treat.

While skin cancer is one of the most common cancers, it is also one of the most preventable. According to the World Health Organization (WHO), four out of five cases can be prevented by following safe-sun practices including limiting your time in the sun, seeking shade, wearing protective clothing and using sunscreens regularly.

Sunscreens are a key factor in preventing and reducing the risk of skin cancer and UV-induced skin damage. Nonprofit health organizations, including the American Cancer Society, American Academy of Dermatology (AAD), Mayo Clinic and Skin Cancer Foundation, recommend using sweat- and water-resistant broad-spectrum (protects against UVA and UVB rays) sunscreens with a sun protection factor (SPF) of 30 or higher as part of a safe-sun regimen. The Centers for Disease Control and Prevention (CDC) notes the importance of daily sunscreen use, including on cloudy and overcast days, to help prevent most skin cancers.

Sunscreen History and Regulation

What many people don’t know is that sunscreens are regulated as over-the-counter (OTC) drugs under a monograph system by the U.S. Food and Drug Administration (FDA). A monograph gives instructions for how to manufacture a product and establishes various requirements for it to be sold and used in the U.S. You can think of it like a recipe in that it provides the types of ingredients, dosage forms, testing methods, labeling requirements and so forth for a given product category, such as sunscreens or antiperspirants. FDA, the regulatory body in the U.S. that comes up with the recipe for all OTC products, requires all sunscreens meet strict product safety, efficacy and labeling standards before they can be marketed or sold in the U.S.

 

The sunscreen monograph has undergone many different regulatory updates throughout the decades.  For example, in early 2019, FDA published a proposed rule for updated sunscreen regulations, called the Sunscreen Tentative Final Monograph (TFM). In March 2020, Congress passed the CARES (Coronavirus Aid, Relief, and Economic Security) Act, a relief legislation in response to the COVID crisis, which also contained some provisions related to sunscreens and the OTC drug system, generally OTC Reform. These provisions referred to earlier FDA sunscreen regulations and took precedence over the proposed 2019 TFM. As part of additional language in the CARES Act, FDA is expected to propose new sunscreen regulations by this fall.

Practically speaking, this is all a bit confusing, and we are waiting to get more information on the implementation of OTC Reform. Here’s what you need to remember in the meantime:

FDA emphasizes that Americans should continue to use sunscreens with other sun-protective measures. The dangers of sun exposure are clear and universally recognized by public health professionals and dermatologists worldwide.

As an industry, we remain deeply committed to product safety and providing consumers with safe and effective products that meet their diverse needs. The more products consumers can choose from, the more likely they are to use the ones they choose. Cosmetics and personal care products companies are proud of the innovative sunscreen products they develop to help protect consumers from the harmful effects of the sun’s UV rays.

This Memorial Day weekend, remember to apply your sunscreen – 30 minutes before going outside and then every two hours, or immediately after swimming or sweating – and enjoy being outside after 14 months of COVID.  

Carl D’Ruiz serves as chair of PCPC’s Sunscreen Consortium, which leads and aligns the U.S. industry’s strategy and approaches for substantiating the safety and efficacy of sunscreen UV filters, and advocates the public health benefits associated with sunscreens.

Statement by Alexandra Kowcz, Chief Scientist, Personal Care Products Council, in Response to the Environmental Working Group’s 2021 Sunscreens Guide


FOR IMMEDIATE RELEASE

CONTACTS:       

Lisa Powers, (202) 297-1232, powersl@personalcarecouncil.org
Stefanie Harrington, (202) 615-6558, harringtons@personalcarecouncil.org
Jamie Kurke, (202) 258-5285, kurkej@personalcarecouncil.org

Washington, D.C. – “The cosmetics and personal care products industry is proud of the innovative sunscreen products we provide to help protect consumers from the harmful effects of the sun’s ultraviolet (UV) rays. Sunscreen use is a crucial and well-recognized step in the fight against skin cancer. It is unfortunate that just as Americans are seeing a light at the end of the tunnel in the fight against COVID-19 and will soon be spending more time outdoors, the Environmental Working Group’s (EWG) 2021 Guide to Sunscreens unnecessarily alarms consumers with information that may be harmful to public health. More importantly, EWG’s claims could keep consumers from using sunscreen altogether.

“EWG’s 2021 shopping guide contains little new information in comparison to previous reports. For example, this report claims that sunscreens containing zinc oxide, titanium dioxide or both as active ingredients are better for consumers and implies a conclusion that the Food & Drug Administration (FDA) – the agency that regulates sunscreens in the U.S. – did not reach. EWG suggests that sunscreen products containing other active ingredients may be harmful. FDA has rejected this characterization and has publicly stated that Americans should continue to use sunscreens.

“Working with our industry, FDA has requested additional information on some sunscreen ingredients, emphasizing that this does not mean that the ingredients are unsafe. Ensuring that consumers have access to products containing a broad variety of sunscreen active ingredients is critical and an important contribution to FDA’s public health mission.

“EWG also claims that the majority of sunscreen products in the marketplace today offer inferior broad-spectrum protection from UV radiation. It is important to note that all sunscreen products in today’s marketplace are regulated by FDA as over-the-counter (OTC) drugs. FDA requires rigorous testing for sunscreen effectiveness (both Sun Protection Factor [SPF] and Broad Spectrum). Broad-spectrum sunscreens must protect against both UVB and UVA radiation. Consumers can be confident that these reliable and credible testing methods, which are well recognized by scientific experts and regulatory authorities across the globe, result in sunscreens that are safe and effective in protecting them from harmful UV rays.

Oxybenzone and Homosalate
“Oxybenzone, unjustly criticized by EWG every year, is one of the few FDA-approved ingredients that provides safe and effective broad-spectrum protection, and has been approved and safely used since 1978. Additionally, it is approved for use in Europe, Canada, Japan, Australia, China, Korea, Mexico, Taiwan and Brazil. Oxybenzone protects against UVA rays, which penetrate more deeply into the skin and have been scientifically proven to contribute to skin cancer.

“Homosalate is another active ingredient mentioned in EWG’s guide. This UV filter has also been approved by FDA for use in sunscreens since 1978 and has a long history of use in Europe, Japan, China, Australia, Canada and South America.

Sunscreens and Sun Safety
“The American Cancer Society, American Academy of Dermatology, the Mayo Clinic and the Skin Cancer Foundation recommend using sunscreen as part of a safe-sun regimen to prevent skin cancer. The Centers for Disease Control and Prevention’s Sun Safety recommendations note the importance of daily sunscreen use, including on cloudy and overcast days, to help prevent most skin cancers. Sun exposure dangers are clear and universally recognized by public health professionals and dermatologists. The National Toxicology Program 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 10 a.m. – 4 p.m.
  • 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 continues to be to help consumers make informed decisions and use sunscreen as an important part of a daily safe-sun program. It is our hope that using sunscreen becomes as much of a habit as using your seat belt.”

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

Based in Washington, D.C., the Personal Care Products Council (PCPC) is the leading national trade association representing global cosmetics and personal care products companies. Founded in 1894, PCPC’s 600 member companies manufacture, distribute and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products millions of consumers rely on and trust every day – from sunscreens, toothpaste and shampoo to moisturizer, makeup and fragrance – personal care products companies are global leaders committed to product safety, quality and innovation.

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Study Demonstrates Environmental Risk Assessments on Coral Reefs Are Insufficient


FOR IMMEDIATE RELEASE

CONTACTS:     

Stefanie Harrington, (202) 615-6558, harringtons@personalcarecouncil.org
Jamie Kurke, (202) 258-5285, kurkej@personalcarecouncil.org

Study Demonstrates Environmental Risk Assessments on Coral Reefs Are Insufficient
Researchers Find Lack of Evidence that UV Sunscreen Filters are Significantly Impacting Corals

Washington, D.C. – A newly published critical scientific review by environmental scientists from the University of Maryland Center for Environmental Science (UMCES) Chesapeake Biological Laboratory and the Personal Care Products Council (PCPC) shows that ultraviolet (UV) sunscreen filters pose a minimal risk to coral. In addition, it underscores the need for further research to allow the scientific community to form a consensus based on reliable studies.

Carys Mitchelmore, Ph.D., professor, UMCES; Emily Burns, Ph.D., environmental scientist, PCPC; Andrew Heyes, Ph.D., associate research professor, UMCES; Annaleise Conway, graduate research assistant, Chesapeake Biological Laboratory; and Iain Davies, Ph.D., director of PCPC’s environmental science programs, co-authored the study, “Organic UV Filters in the Marine Environment: A Critical Review and Analysis of Coral Exposure, Hazard and Risk,” published in Environmental Toxicology and Chemistry.

Degradation of the world’s coral reefs is a serious concern and evaluating the impact of UV filters is critically important. This comprehensive review of coral toxicity data and environmental monitoring of UV filter levels near coral reefs suggests that these filters do not pose a significant risk to corals residing in marine habitats, based on current data.

“Corals are faced with multiple physical, biological and chemical stressors, and currently there is very limited scientific data on the role that UV filters have on causing harm to the reefs,” said Mitchelmore. “That is why this review is so important. Scientists from academia, government and industry need to work together to best determine which stressors are most damaging to reefs to prioritize the most effective management and regulatory actions at the local through global scales.”

The review highlights major data gaps and also data reliability issues with several high-profile coral toxicity studies that have been used to justify several recent state sunscreen/UV filter restrictions. It is important that policymakers and regulators are aware of such data deficiencies before making any future environmental management decisions. Given the limited body of science currently available, the UMCES and PCPC authors provide research recommendations that will help to provide the data needed to conduct a conclusive risk assessment and help the scientific community reach a consensus on the environmental safety of UV filters.

“It is crucial to conduct robust environmental risk assessments for UV filters, and a key part of this work is ensuring the scientific community has comprehensive, reliable datasets. PCPC’s scientists are committed to working with experts from industry, academia, government and NGOs to achieve this goal through innovative environmental research,” Davies stated.

To date, there is no convincing scientific evidence that under naturally occurring conditions, UV sunscreen filters contribute to the degradation of coral reefs. 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 climate change, disease, coastal development, and a number of chemical contaminants from agricultural and other land-based sources.

Finally, skin cancer is the most common form of cancer, with one in five people in the U.S. expected to be diagnosed within their lifetime. Ninety percent of non-melanoma skin cancers are associated with exposure to UV radiation from the sun. Sunscreens are a proven preventative barrier to the harmful effects of solar radiation. Making environmental impact decisions on sunscreens based on insufficient scientific data can lead to unintended health consequences, such as fewer available sunscreens and an increase in the prevalence of skin cancer.

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

Based in Washington, D.C., the Personal Care Products Council (PCPC) is the leading national trade association representing global cosmetics and personal care products companies. Founded in 1894, PCPC’s 600 member companies manufacture, distribute and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products millions of consumers rely on and trust every day – from sunscreens, toothpaste and shampoo to moisturizer, makeup and fragrance – personal care products companies are global leaders committed to product safety, quality and innovation.

Partnerships: An Essential Ingredient for Success


Lezlee Westine
President & CEO, Personal Care Products Council

Each new year presents an opportunity to examine our priorities and focus on what matters most. As our nation continues to address the many challenges from 2020, PCPC stands ready in 2021 with renewed energy and sense of purpose.

As our country begins to heal from the tragic events of January 6 and focuses on unity in light of a new administration and new Congress, PCPC and our member companies remain steadfast in our commitment to bipartisan collaborations that enable and enhance our member companies’ ability to provide safe and innovative products to countless American families.

Partnerships are key to achieving meaningful solutions to some of our biggest challenges. From my professional experience in government and the private sector, I know we can accomplish the seemingly impossible by working together. I have seen incredible things achieved when people work towards a common goal.

The spirit of collaboration inspired PCPC to work with policymakers, regulators and NGOs to respond to the COVID-19 pandemic in 2020. We engaged the U.S. Food and Drug Administration (FDA) and Congress to issue temporary guidance allowing non-traditional manufacturers to address the critical shortage of hand sanitizers. Our members quickly converted manufacturing lines and increased production to provide these essential products. Companies donated more than 20 million units of hand sanitizer to hospitals, community clinics, medical and emergency professionals, first responders, industry employees and made them available to retail customers.

The nation also grappled with issues of systemic racism and calls for equality and social justice this past year. As an industry, we intend to be a positive agent of change and a force for good aiming to engage in partnerships that are both authentic and meaningful. We don’t have all the answers and know there is much work still to be done to address diversity. Working in coalition with many diverse organizations in 2020, PCPC supported anti-discrimination legislation, including the CROWN (Creating a Respectful and Open World for Natural Hair) Act, which passed the House in September. The CROWN Act became law in seven states in 2020 and is currently pending in 20+ states this year, preventing discrimination based on characteristics – such as hair texture and cultural styles, particularly those common in the Black community – and specifically recognizing that Black people are disparately impacted and excluded from some workplaces based on physical appearance. Similar legislation has been passed in seven states. Looking ahead, PCPC is committed to taking continued action to examine and address issues of diversity, equity and inclusion (DE&I), both within our organization and in the industry at large, and in partnership with others committed to the same goal.

PCPC’s work with Cruelty Free International proved to be another successful partnership, resulting in compromise agreement on state animal testing legislation, now pending in several states. At the federal level, we worked closely with the Humane Society of the United States (HSUS) to introduce the Humane Cosmetics Act, which would ban cosmetic animal testing in the U.S. We will continue to work with HSUS and our congressional partners to pass this legislation in the 117th Congress.  

The power of partnerships was also demonstrated in our work with the American Society for Dermatologic Surgery Association (ASDSA), American Academy of Dermatology (AAD), and more than 60 other health, education and parent groups to support legislation that specifically allows sunscreens to be used in schools. To date, 26 states and Washington, D.C., have passed the “SUNucate” model.

Partnerships are key to our industry’s continued success, and we remain committed to deepening and broadening them in the year ahead. As President Biden noted: “To live together and work together. That’s how I see America. That’s how I see the presidency, and that’s how I see the future.” This year, PCPC re-dedicates itself to boldly push forward – confronting the challenges ahead while ensuring our member companies can continue to enhance the well-being of countless American families with the cosmetics and personal care products they trust and enjoy every day. 

Statement by Linda Loretz, PhD, Chief Toxicologist, Personal Care Products Council, in Response to the Wall Street Journal’s Column on Sunscreens


FOR IMMEDIATE RELEASE

CONTACTS:

Lisa Powers, (202) 297-1232, powersl@personalcarecouncil.org
Jamie Kurke, (202) 258-5285, kurkej@personalcarecouncil.org

Washington, D.C. – “The Wall Street Journal article, ‘Sunscreen Chemicals Accumulate in Body at High Levels,’ published July 17, 2020, is misleading and unnecessarily alarming about the safety of sunscreen products on the market today. The level of chemicals in the blood referred to in the article was the threshold set by the U.S. Food & Drug Administration (FDA) for requiring additional testing to determine if sunscreens currently on the market meet FDA’s standards to be considered Generally Recognized As Safe (GRAS). It did not represent a level considered to be unsafe.

“In fact, FDA’s statement on the study referenced in the article, published in January of this year, clearly states that absorption does not equal risk; FDA did not conclude that the study results indicated sunscreen ingredients are unsafe. FDA goes on to say that without further testing, it does not know what levels of absorption can be considered safe. Most importantly, FDA advises people to continue to use sunscreens in conjunction with other sun safety precautions while the Agency collects additional data.

“The comparison of the levels of sunscreen observed in the blood in FDA’s study to levels of THC (the active compound in marijuana) and alcohol after drinking two beers is another misguided attempt to needlessly scare consumers. A comparison of a controlled substance and an alcoholic beverage to sunscreen is entirely inappropriate, and the numbers are wildly inaccurate.

“The Personal Care Products Council and our member companies will continue to work cooperatively with FDA to determine what additional studies may be needed to ensure the ongoing safety of sunscreen active ingredients in the marketplace. We share FDA’s mission to protect public health and are committed to providing safe and effective products for consumers. We are proud that our industry offers innovative sunscreen products that help protect consumers from the harmful effects of the sun’s ultraviolet (UV) rays.”

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

Based in Washington, D.C., the Personal Care Products Council (PCPC) is the leading national trade association representing global cosmetics and personal care products companies. Founded in 1894, PCPC’s approximately 600 member companies manufacture, distribute and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products millions of consumers rely on and trust every day – from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance – personal care products companies are global leaders committed to product safety, quality and innovation.

Statement by Alexandra Kowcz, Chief Scientist, Personal Care Products Council in Response to the Environmental Working Group’s 2020 Sunscreens Report


FOR IMMEDIATE RELEASE 

CONTACTS:

Lisa Powers, (202) 297-1232, powersl@personalcarecouncil.org
Jamie Kurke, (202) 258-5285, kurkej@personalcarecouncil.org

Washington, D.C. – “The cosmetics and personal care products industry is proud of the innovative sunscreen products we provide to help protect consumers from the harmful effects of the sun’s ultraviolet (UV) rays.  Sunscreen is a crucial and well-recognized step in the fight against skin cancer.  It is unfortunate that at precisely the time that COVID-19 stay at home orders are being lifted and Americans may be heading to beaches and pools, the Environmental Working Group’s (EWG) 2020 Guide to Sunscreens attempts to needlessly scare consumers with false claims and misinformation that can be potentially harmful to public health.

“Year after year, EWG’s shopping guide contains little new information in comparison to their previous reports, and their 2020 edition is no different. More importantly, the claims made by EWG could actually keep consumers from using sunscreen altogether. For example, EWG’s recommendation about which sunscreens consumers should use (i.e. those containing only zinc oxide or titanium dioxide as active ingredients) implies a conclusion that the Food & Drug Administration (FDA) itself did not reach. EWG suggests that sunscreen products containing other active ingredients are unsafe or ineffective. FDA has rejected this characterization and has publicly stated that Americans should continue to use sunscreens and also stated that the results from the Agency’s study does not mean that the ingredient is unsafe, nor does the FDA seeking further information indicate such. Instead, FDA has requested additional information and our industry is working closely with the Agency to supply the information.

“EWG also claims that three fourths of sunscreen products in the marketplace today offer inferior UV protection (according to EWG’s testing methods). It is important to note that all sunscreen products in today’s marketplace are regulated by the FDA as over-the-counter (OTC) drugs.  FDA requires rigorous testing for sunscreen effectiveness (both Sun Protection Factor [SPF] and Broad Spectrum). Consumers can be confident that these reliable and credible testing methods that are well recognized by experts and regulatory authorities across the globe 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. The methods used by EWG have not been subject to scrutiny or approval by any scientific or regulatory agency.

Oxybenzone and Retinyl Palmitate

“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 and safely used since 1978. According to the American Academy of Dermatology (AAD), available peer-reviewed scientific literature, and current regulatory assessments from national and international bodies around the world, there is no causal link between oxybenzone use in sunscreen and significant hormonal alterations or 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 also is an ingredient approved by the FDA for use in sunscreens and several other OTC products.

Sunscreens and Sun Safety

“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 sunscreens 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 Toxicology Program 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. It is our hope that using sunscreen becomes as much of a habit as using your seat belt.”

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

Based in Washington, D.C., the Personal Care Products Council (PCPC) is the leading national trade association representing global cosmetics and personal care products companies. Founded in 1894, PCPC’s approximately 600 member companies manufacture, distribute and supply the vast majority of finished personal care products marketed in the U.S. As the makers of a diverse range of products millions of consumers rely on and trust every day – from sunscreens, toothpaste and shampoo to moisturizer, lipstick and fragrance – personal care products companies are global leaders committed to product safety, quality and innovation.

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Sun Safety in the Shadow of COVID-19


Alexandra Kowcz
Chief Scientist, Personal Care Products Council

Memorial Day Weekend signals the arrival of summer and, with it, familiar warm-weather activities like afternoons at the beach or pool, back-yard BBQs and more time spent outdoors. For many people across the country who have respected the stay-at-home orders to help mitigate the spread of COVID-19, summer cannot come soon enough. And while many states have initiated reopening plans to reboot their economies – easing restrictions on beaches, parks and other outdoor recreational sites – this will not be a typical summer. Although scientists continue to study whether higher temperatures, humidity and sunlight will have a mitigating impact on the spread of COVID-19, health agencies continue to recommend the use of face masks and social distancing.

In addition to these new COVID-19 behaviors we have adopted to keep us healthy, we also need to practice sun safety. While we may be experiencing a vitamin D deficiency from sheltering indoors, it is important to take precautions to protect ourselves from the sun’s damaging rays once we emerge from our homes. Experts believe four out of five cases of skin cancer caused by ultraviolet (UV) exposure could be prevented.

As we begin to venture outdoors, here is a reminder of the measures you can take to stay safe in the sun:

Limit Your Exposure

To protect against damage from the sun’s rays, try to avoid the sun between 10 a.m. and 4 p.m., when the rays are strongest. Another approach to determine when best to stay out of the sun is by using the shadow rule: “Short Shadow, Seek Shade.” The intensity of UV rays is directly related to the angle of the sun (or altitude above the horizon). When a person’s shadow is shorter than they are tall, the intensity of UV rays is more likely to cause sunburn.

You can also consult the UV Index, which indicates how strong the UV light is in your area on any given day. Developed by the U.S. National Weather Service and Environmental Protection Agency, a higher number (from 1 to 11+) means greater risk of exposure and higher chance of sunburn and skin damage that could ultimately lead to skin cancer. When the sun is strongest, seek shade under an umbrella, tree or other sun blocking structure.

Wear Protective Clothing

Hats, sunglasses and long-sleeved shirts and pants can provide important protection from UV rays. Clothing made from tightly woven fabric, wide-brimmed hats and sunglasses that block both UVA and UVB rays offer the best protection. Some clothing certified under international standards comes with information on its ultraviolet protection factor.

Liberally Apply Sunscreen

Sunscreens are designed to protect the skin by absorbing, reflecting or dispersing the sun’s rays and are typically categorized into either UV absorbers or UV reflectors. UV absorbers are chemicals, like avobenzone and octinoxate, that absorb UV radiation and convert it to a very low level of heat. UV reflectors block and scatter the rays before they penetrate the skin and include minerals like titanium dioxide or zinc oxide. Both types of sunscreens are available in many forms including lotions, creams, ointments, gels, sprays and balms.

Sunscreens are assigned a sun protection factor (SPF) that rates their effectiveness in blocking UV rays. A product’s SPF helps determine how long it will protect you before you need to re-apply or how long you can stay in the sun without burning. For example, if unprotected skin takes ten minutes to show signs of burning, SPF 30 sunscreen (when properly applied) would slow the rate of burning by 30 times, or 300 minutes in total. SPF 15 would provide 150 safe minutes; SPF 50, 500 minutes; etc.

You should always wear a sunscreen with at least SPF 30, no matter your skin tone. Even people with very dark skin can burn and develop skin cancer. When you see the term “broad spectrum” on a sunscreen product, it means you have protection from both UVA and UVB rays.

Apply your sunscreen liberally at least 30 minutes before going outside and remember to re-apply it every two hours and immediately after swimming or perspiring. If you’re taking medication, ask your doctor if it will make your skin more sensitive to the sun. Certain antibiotics, birth control pills, diuretics, antihistamines and anti-depressants can increase one’s sensitivity to the sun’s rays.

Health and safety are, rightfully, in the spotlight these days. In addition to social distancing and wearing a face covering, don’t forget to protect yourself from the damaging effects of the sun!