Statement: Personal Care Products Council Regarding the Safety of Sunscreen Ingredient Oxybenzone

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Statement by Farah Ahmed, Chair, Sunscreen Committee, Personal Care Products Council Regarding the Safety of Sunscreen Ingredient Oxybenzone

Submitted by 32652.49986 on May 15, 2012

“It is important for consumers to understand the dangers of sun exposure and practice a holistic sun safe regimen, including daily use of sunscreen, to protect them from skin cancer, premature skin aging, and other damaging effects of the sun. 


Benzophenone is not a sunscreen ingredient


“Oxybenzone (Benzophenone-3) is an approved OTC sunscreen active ingredient.  It is one of the few approved UV filters that provide broad-spectrum protection from both UVA and UVB rays and is widely used to protect consumers against harmful effects from the sun. It is sometimes confused with benzophenone. Benzophenone-3 does not contain benzophenone.

Oxybenzone Is Safe and Not an Endocrine (Hormone) Disrupting Chemical


“The global safety profile for oxybenzone is robust and demonstrates that this sunscreen ingredient is safe (and effective).[1]  Leading scientific, regulatory, and medical organizations in the U.S. and around the world unequivocally find that oxybenzone does not cause endocrine disruption.  A few examples include:

  • U.S. NTP (National Toxicology Program) – studied oxybenzone and found no indication from the data that the ingredient is endocrine disruptive.[2]
  • U.S. Food and Drug Administration (FDA) – reviewed and approved oxybenzone as a sunscreen ingredient since 1978 and continues to recognize it as safe and effective.[3]
  • Cosmetic Ingredient Review (CIR) (CIR) – reviewed and determined benzophenone-3 (oxybenzone) to be safe.[4]
  • European Union Cosmetic Ingredient Authority – Based on the actual scientific knowledge, the SCCNFP is of the opinion that the organic UV-filters used in cosmetic sunscreen products, allowed in the EU market today, have no estrogenic effects that could potentially affect human health.[5]
  • Health Canada – has reviewed and approved oxybenzone as a safe and effective sunscreen ingredient.[6]   
  • All ASEAN (South East Asian Nations) governments permit the use of oxybenzone as a safe and effective sunscreen ingredient.
  • American Academy of Dermatology (AAD) is unequivocal in its support of the safety of oxybenzone: 

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. “Available peer-reviewed scientific literature and regulatory assessments from national and international bodies do not support a link between oxybenzone in sunscreen and hormonal alterations, or other significant health issues in humans,” stated Dr. Siegel. The FDA has approved oxybenzone in sunscreen for use on children older than six months, and dermatologists continue to encourage protecting children by playing in the shade, wearing protective clothing and applying broad-spectrum sunscreen.[7]

  • The Skin Cancer Foundation – The Photobiology Committee reviewed the studies on oxybenzone and found no basis for concern.[8]

UV Light Is a Recognized Carcinogen

“The dangers of the sun are clear and widely recognized by scientists and dermatologists, industry, FDA, the Center for Disease Control and other health organizations in the U.S. and worldwide.  The World Health Organization and the National Institutes of Health identify solar UV radiation as a carcinogen.  A single bad burn as a child increases the skin’s susceptibility to damage and skin cancer throughout life.  Consumers can be confident that sunscreen products, when used as directed and as part of an overall safe sun regimen, are safe and will help protect them from skin cancer, premature skin aging, and other damaging effects of the sun.”

 

For more information about the safety and efficacy of sunscreens, please visit www.CosmeticsInfo.org and the U.S. Food and Drug Administration’s website, www.FDA.gov.

Based in Washington, D.C., the Personal Care Products Council is the leading national trade association representing the global cosmetic and personal care products industry. Founded in 1894, the Council's more than 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 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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[1] For example, the Journal of Investigative Dermatology published a clinical study with whole body application of a commercial sunscreen product with 10% oxybenzone, no product-related changes to hormone levels were observed. J Invest Dermatol 123:57 –61, 2004.

[2] NTP http://ntp.niehs.nih.gov/?objectid=071CEFFD-E2C3-E8A8-786A3758F293EFBD

[3] FDA http://frwebgate1.access.gpo.gov/cgi-bin/PDFgate.cgi?WAISdocID=537756507619+1+2+0&WAISaction=retrieve

[4] CIR is an independent panel of leading scientific and medical experts, including FDA and key opinion leaders in dermatology, who assess the safety of cosmetic ingredients used in the U.S. http://www.cir-safety.org/index.shtml   

[5] European Union http://ec.europa.eu/health/scientific_committees/consumer_safety/opinions/sccnfp_opinions_97_04/sccp_out145_en.htm

[6] Health Canada http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/mono_sunprotect_ecransolaire-eng.php

[7] AAD http://www.aad.org/stories-and-news/news-releases/sunscreen-remains-a-safe-effective-form-of-sun-protection

[8] Skin Cancer Foundation http://www.skincancer.org/prevention/sun-protection/sunscreen/if-recent-attacks-on-sunscreen-concern-you