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Sunscreen Safety Concerns


Last update: August, 2011
RMS Manufactures Safe Sunscreen
All Rocky Mountain Sunscreen ingredients and formulas are approved by the FDA and have been thoroughly tested by numerous independent testing agencies.

We feel that it is important that you be informed and have the proper information regarding sunscreen safety. We would like to make you aware of two recent controversies surrounding sunscreen ingredients targeted by a single large well funded lobby group and sensationalized by the media. We understand and respect your concerns, please call us at 888-356-8899 with any additional questions.

Independent, respected organizations and experts disagree with claims connected to Oxybenzone and Vitamin A: Food & Drug Administration, Skin Cancer Foundation, American Academy of Dermatology, Cosmetic Ingredient Review Expert Panel, Personal Care Products Council, & Household and Personal Products Industry. Who should you trust for advice on product safety: credible and knowledgeable scientific sources or an activist group with questionable credibility and hypothetical concerns?

Oxybenzone may be unsafe: UNFOUNDED

The foundation for the recently-raised concern about Oxybenzone (an active ingredient found in most sunscreens) is based on disproportionate research done on rodents. Since FDA approval in 1978, there has never been evidence of any adverse reactions in humans (please read an abstract on human testing from the Dept. of Pharmacology and Toxicology at UMDNJ, here). Additionally, the Skin Cancer Foundation Photobiology Committee reviewed the studies and found no basis for concern; the Cosmetic Ingredient Review Expert Panel tested Oxybenzone in 2005 and confirms its safety. All sunscreen ingredients are safe at the dose and concentration found in topically applied sunscreens; topical exposure is not equivalent to feeding large highly concentrated doses to laboratory animals.
  • Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research quoted in 2011 press release that oxybenzone has "been in use for years and that there are no safety alerts" 13 and "the FDA does not have any reason to believe these products are not safe for consumer use"14
  • Oxybenzone is a safe sunscreen ingredient, according to Dr. Morison, chairman of the Skin Cancer Foundation’s Photobiology Committee and Professor of Dermatology at John Hopkins University.1
  • Review panel arrived at conclusion that Oxybenzone is not a cause for concern, in claims about increased incidence of melanomas or hormone disruption, according to a 2010 Skin Cancer Foundation statement. 1
  • Skin Cancer Foundation goes on record to say that oxybenzone is a safe and effective UV filter, having been approved, after extensive review, by the FDA, Canada, the European Union, and many Asian countries, says Dr. Perry Robins.2
  • "The safety and efficacy of sunscreen products have been thoroughly studied and tested by scientists and regulatory authorities throughout the world. Safety and efficacy of these products remains the highest priority for sunscreen manufacturers", according to Personal Care Products Council Chief Scientist, John Bailey.3
  • Regarding Oxybenzone studies, Dr. Nadim Shaath with HAPPI, cites Dr. Henry Lim (Ford Hospital in Detroit) as saying, “animals were fed significantly greater amounts than commonly applied in sunscreen products.”4
  • Laboratory rats smeared with topical benzophenone-3 (Oxybenzone, BZ-3), an active ingredient in sunscreen showed no signs of toxicity, according to studies by the University of Medicine and Dentistry of New Jersey, New Jersey Medical School. “BZ-3 is not toxic to rats when applied dermally…”.5
  • “It is concluded that the human viable epidermal levels of sunscreens aretoo low to cause any significant toxicity to the underlying human keratinocytes,” according to Therapeutics Research Unit, Southern Clinical School, University of Queensland.6
  • Oxybenzone's safety was also reviewed and confirmed by the Cosmetic Ingredient Review Expert Panel in 2005. 7

Retinyl palmitate may contribute to skin cancer: INCONCLUSIVE

To date, there is no scientific evidence that retinyl palmitate (Vitamin A) in sunscreen causes skin cancer. The study being cited in this concern is a 10 year old study on rodents using retinyl palmitate as a concentrated stand alone ingredient rather than a small percentage within a combination of ingredients. What is more, the trace amount used in sunscreen is staggeringly less than the amount that was used in the study (study: 0.1 grams per ounce compared to sunscreen: 0.0000029 grams per ounce). In an effort to meet our customer's requests, we have removed this miniscule amount of Vitamin A from the majority of our products (products still containing Vitamin A: 1oz SPF 30, 2oz SPF 30, & 2oz SPF 50).
  • "Retinyl palmitate is approved by the Food and Drug Administration (FDA) for use in over-the-counter and prescription drugs, and it is also used as a food additive (e.g., to fortify low-fat milk, dairy products and breakfast cereals with vitamin A)."8
  • "When used in sunscreen, retinyl palmitate is not an active drug ingredient (unlike sunscreen filters), but rather a cosmetic ingredient. In sunscreen, it can serve as an antioxidant to improve product performance against the aging effects of UV exposure or to enhance the aesthetic qualities of sunscreen."8
  • "It is important to note that the mice in the NTP study are highly susceptible to the effects of UV radiation and can develop skin cancer or other skin abnormalities within weeks of UV exposure, even in the absence of retinyl palmitate," said Dr. Wang. "That is why extremecaution is needed when extrapolating these animal study results to humans."8
  • Otherwise stated, the NTP study has not been peer reviewed and was not developed to study retinyl palmitate in sunscreen.
  • "To date, there isno scientific evidence that vitamin A is a carcinogen in humans…"9 Responds the Skin Cancer Foundation to questions about reports concerning the safety of sunscreens containing retinyl palmitate (Vitamin A).
  • "Only trace amounts of retinyl palmitate appear in sunscreens, and some evidence suggests that it is actually protective against cancer."9
  • "After reviewing the recently released report, The Skin Cancer Foundation's Photobiology Committee,...have come to the conclusion that there is no scientific evidence to support claims that retinyl palmitate (Vitamin A) is a photocarcinogen in humans."10
  • “Repeated topical treatment, in contrast to single oral doses, with Vitamin A-containing preparations does not affect plasma concentrations of retinol, retinyl esters or retinoic acids in female subjects of child-bearing age” according to an abstract from the National Library of Medicine.11


References:
1 Skin Cancer Foundation, The. (July, 15 2010). Sunscreen Criticisms Not Based on Hard Science. New York: The Skin Cancer Foundation: 2010. (http://www.skincancer.org/sunscreen-criticisms-unfounded.html).
2 Skin Cancer Foundation, The. (2010). Sun and Skin News: AMessage from the President 25.3. New York: The Skin Cancer Foundation:2010. (http://www.skincancer.org/Sun-and-Skin-News).
3 Personal Care Products Council. (May, 24 2010). Statement byJohn Bailey, Chief Scientist, Personal Care Products Council, Response to the2010 EWG Sunscreen Report. Washington, D.C.: Personal Care ProductsCouncil: 2010. (http://www.personalcarecouncil.org/newsroom/20100524).
4Shaath, Nadim (Phd). (2010). Shadows Cast on Sunscreens.The Sunscreen Filter. Household and Personal Products Industry. (http://happi.com/articles/2010/07/the-sunscreen-filter)
5 Okereke CS, Barat SA, Abdel-Rahman MS. (1995). Safetyevaluation of benzophenone-3 after dermal administration in rats.Department of Pharmacology and Toxicology, University of Medicine and Dentistryof New Jersey, New Jersey Medical School, Newark 07103-2714, USA. Toxicol Lett.1995 Oct;80(1-3):61-7. PMID: 7482593 [PubMed - indexed for MEDLINE]. (http://www.ncbi.nlm.nih.gov/pubmed/7482593).
6Hayden CG, Cross SE, Anderson C, Saunders NA, Roberts MS. (2005).Sunscreen penetration of human skin and related keratinocyte toxicity aftertopical application. Therapeutics Research Unit, University of Queensland,Southern Clinical School, University of Queensland, Princess AlexandraHospital, Brisbane, Australia. Skin Pharmacol Physiol. 2005Jul-Aug;18(4):170-4. Epub 2005 May 20. PMID: 15908756 [PubMed - indexed forMEDLINE]. (http://www.ncbi.nlm.nih.gov/pubmed/15908756).
7Cosmetic Ingredient Review Expert Panel. (2008). Annual reviewof cosmetic ingredient safety assessments: 2005/2006. Cosmetic IngredientReview, Washington DC 20036, USA. Skin Int J Toxicol. 2008;27 Suppl 1:77-142.(http://www.cir-safety.org/publications.shtml).
8American Academy of Dermatology. (2010). Analysis FindsSunscreens Containing Retinyl Palmitate Do Not Cause Skin Cancer. AmericanAcademy of Dermatology, PR News Wire August 10, 2010. http://www.prnewswire.com/news-releases/analysis-finds-sunscreens-containing-retinyl-palmitate-do-not-cause-skin-cancer-100332434.html
9Skin Cancer Foundation, The. (2010). If Recent Attacks onSunscreen Concern You. . . The Skin Cancer Foundation PhotobiologyCommittee: 2010. http://www.skincancer.org/recentattackssunscreen.html?gclid=CJq45dPqsaMCFRtinAodk0Q65A
10Skin Cancer Foundation, The. (2010). Response to TheEnvironmental Working Group 2010 Report and Senator Schumer. The SkinCancer Foundation Photobiology Committee: 2010. http://www.skincancer.org/response-to-the-environmental-working-group-2010.html
11Nohynek GJ, Meuling WJ, Vaes WH, Lawrence RS, Shapiro S, SchulteS, Steiling W, Bausch J, Gerber E, Sasa H, Nau H. (2006). Repeated topicaltreatment, in contrast to single oral doses, with Vitamin A-containingpreparations does not affect plasma concentrations of retinol, retinyl estersor retinoic acids in female subjects of child-bearing age. L'OrealR&D, Worldwide Safety Evaluation, 25-29 Quai Aulagnier, 92600Asnières, France. Toxicol Lett. 2006 May 5;163(1):65-76. Epub 2005 Oct 21.PMID: 16243460 [PubMed - indexed for MEDLINE]. (http://www.ncbi.nlm.nih.gov/pubmed/16243460).
12Shaath, Nadim (Phd). (2010). JAAD: Retinyl Palmitate inSunscreen Does Not Cause Cancer. The Sunscreen Filter. Household andPersonal Products Industry. August, 2010. http://www.happi.com/news/2010/08/10/jaad:_retinyl_palmitate_in_sunscreen_does_not_cause_cancer?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+HappiBreakingNews+(Happi+Breaking+News)
13Shaath, Nadim (Phd). (2011). Finally...The Final Rule OnSunscreen Labeling. The Sunscreen Filter. Household and Personal ProductsIndustry. July, 2011. http://www.happi.com/articles/2011/07/the-sunscreen-filter
14FDA Press Release. (2011). FDA Announces Changes to BetterInform Consumers About Sunscreen. June 14, 2011. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2011/ucm258940.htm