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Facts About Sunscreen
Practice Safe Sun Daily
The Personal Care Products Council joins with the American Academy of Dermatology, the Skin
Cancer Foundation, Centers for Disease Control, FDA and other health professionals in urging
consumers to minimize their sun exposure as part of an overall safe sun strategy. This includes
taking a variety of sun protection steps: limiting time in the sun, especially from 10:00 a.m. -2:00
p.m., wearing protective clothing, and using sunscreen daily.
Regulation of sunscreen Products
Sunscreen products are thoroughly studied and tested by qualified scientists and regulatory
authorities throughout the world. In the U.S., sunscreens are regulated as over-the-counter (OTC)
drugs by the U.S. Food & Drug Administration (FDA) and are subject to rigorous scientific
assessment, including safety and efficacy substantiation according to FDA standards which are
among the most rigorous in the world.
The EWG 2012 Sunscreen Report is Filled With Unsubstantiated Assertions,
Contradictions, and Distorted Facts. Some Examples Include:
Skin Cancer
EWG’s assertions are contrary to the body of scientific and medical data that recognizes the use
of sunscreen as part of an overall program of sun safety to help protect against skin cancer and
other forms of damage caused by the sun.
Melanoma remains one of the most deadly cancers in the U.S., and sunscreen has been
scientifically proven to reduce a person’s risk. EWG’s campaign of misinformation risks
severely negative public health consequences if it deters consumers from using appropriately
rated sunscreens.
The dangers of the sun are clear and widely recognized by sunscreen experts and dermatologists.
A National Institutes of Health “Report on Carcinogens” identifies solar UV radiation as a
“known human carcinogen.” Further, a single bad burn as a child is known to increase the skin’s
susceptibility to damage and skin cancer throughout life. In light of this scientifically sound and
somber evidence of the dangers of the sun, it is alarming that EWG’s “annual report” could
cause some consumers to avoid using sunscreens on themselves and their children.
EWG’s report cites increasing skin cancer rates and questions sunscreen efficacy in fighting this
dangerous disease. EWG fails to consider that higher skin cancer rates are the result of excessive
unprotected sun exposure from several previous decades, as well as the large increase in
unprotected use of tanning beds, particularly by young people. In addition, our ability to better
track, monitor, and report occurrence of the disease has significantly increased over the years.
It is important to understand that approximately 90 percent of non-melanoma skin cancers are
associated with exposure to ultraviolet (UV) rays from the sun.i Each year there are more new
cases of skin cancer than the combined incidences of cancers of the breast, prostate, lung and
colon.ii Further, up to 90 percent of the visible changes commonly attributed to aging are caused
by the sun.iii
Vitamin A in sunscreen
Unfortunately, EWG has inappropriately alarmed consumers by telling them that products
containing retinyl palmitate, including sunscreens, may not be safe. Their position is simply not
supported by available scientific data.
Retinyl palmitate, commonly known as Vitamin A, has been used safely for many years in
various cosmetic and OTC drug preparations, including sunscreen products. Vitamin A, an
important vitamin in humans, is made up of a family of compounds called retinoids. Retinoid
esters, including retinyl palmitate, account for more than 70 percent of Vitamin A. Retinyl
palmitate is approved by FDA as a food additive. Retinyl palmitate has been reviewed by the
Cosmetic Ingredient Review (CIR) twice and found to be safe for use in cosmetics. CIR is an
independent panel of renowned scientific and medical experts that assesses the safety of
cosmetic ingredients used in the U.S.
Despite the EWG allegations, there is no compelling evidence that retinyl palmitate in sunscreen
products presents any human health risk to consumers. In 2000, the National Toxicology
Program (NTP) published a notice stating that it would study the potential of retinyl palmitate to
enhance UV radiation-induced photocarcinogenicity. The NTP report for the study was issued in
2011. Serious methodological flaws were associated with the studies in that the controls were
improperly formulated and obscured the ability to detect any affect arising from retinyl
palmitate. In fact, the flaws are so significant that the results of the study cannot be used for a
science-based assessment of risk. In spite of these flaws, the NTP Peer Review Panel
nevertheless concluded there was an effect above the control- (cream without retinyl palmitate)
used in the test. It should be noted that there is a large body of evidence that in humans,
retinoids have anti-cancer effects, in contrast to the effects sometimes seen in mouse models.
Safety of Oxybenzone
The EWG also questions the safety of an FDA-approved active ingredient in some sunscreens
called oxybenzone. When used as a sunscreen ingredient, oxybenzone, also known as
Benzophenone-3, protects the skin from harmful UV rays. EWG alleges a connection between
UV filters found in sunscreens, like oxybenzone and hormone or endocrine disruption, but to
date, available scientific data does not support a link between UV filter exposure and endocrinedisruptive effects in humans.
FDA and regulatory authorities in Canada and the European Union have approved the use of
oxybenzone as a safe and effective OTC sunscreen ingredient.
Sunscreen and Free Radicals
It is well known that UV light can produce free radicals in the surface of the skin and that this
leads to the damage associated with excessive exposure to sunlight, most often observed as
redness or sunburn.iv The skin produces natural barriers such as melanin that absorb the UV light
to protect against damage. The interaction of solar UV with these natural barriers can produce
free radicals.
The application of a sunscreen supplements the natural UV absorbers and protects against free
radical formation and the associated damage that can occur.
Every sunscreen is tested in an SPF test to establish the level of protection provided by the
product. These tests confirm that even with doses of UV light, which do produce free radicals
and redness, the presence of sunscreens blocks such reactions.
By virtue of their ability to absorb UV radiation before it can interact with skin, sunscreen
provides significant protection against UV-induced free radical formation within skin compared
with unprotected skin. Studies have documented the protective effects of individual sunscreen
actives as well as commercial sunscreen products for their ability to protect against UV-induced
free radical formation within skin.v
Vitamin D
EWG outlines the benefits of vitamin D, but then creates confusion and needless concern by
mischaracterizing the role of sunscreens in cases of alleged Vitamin D deficiency. AAD notes
that getting Vitamin D primarily from sun exposure is not advisable.vi While UV radiation is one
source of Vitamin D, it is not the best source because the benefits of obtaining Vitamin D
through UV exposure cannot be separated from an increased risk of skin cancer. Instead, the
AAD recommends that ‘…an adequate amount of vitamin D be obtained from a healthy diet that
includes foods naturally rich in Vitamin D (e.g., dairy products and fish), foods/beverages
fortified with Vitamin D (e.g., fortified milk and fortified cereals), and/or Vitamin D
supplements.’vii
Nanotechnology
EWG questions the safety of the inclusion of nanoparticles in sunscreen products, despite the
fact that the general scientific consensus is that nano-sized titanium dioxide and zinc oxide in
personal care products pose no risk to human health. The active ingredients in sunscreen, some
of which utilize sun-protecting nanoparticles, go through an extensive FDA review process to
demonstrate they are safe and effective.
All sunscreen active ingredients, including those which utilize sun-protecting nanoparticles, go
through an extensive FDA review process to demonstrate their safety and efficacy.
Stability
The 2012 EWG report claims that many sunscreen ingredients break down significantly when
exposed to sunlight and quickly stop working. This is simply not true. FDA requires that
sunscreens meet strict stability testing requirements to ensure they are effective following
purchase by consumers. Sunscreen formulators take into account the physical and chemical
properties of the active ingredients to ensure they perform effectively and meet all established
FDA requirements, including chemical stability.
EWG Product Rating System
Ignoring the scientific and regulatory safety assessment process for sunscreen products and
ingredients, EWG invents its own product rating system that is not based on any credible
scientific methodology. In fact, EWG’s methodology for UV absorbance has been proven to be
unreliable by sunscreen experts, both in the U.S. and abroad.
i
Pleasance ED, Cheetham RK, Stephens PJ, et al. A comprehensive catalogue of somatic
mutations from a human cancer genome. Nature; 2009; 463:191-196.
ii
Stern, RS. Prevalence of a history of skin cancer in 2007: results of an incidence-based model.
Arch Dermatol 2010; 146(3):279-282.
iii
U.S. Environmental Protection Agency. Health effects of overexposure to the sun. July 1, 2010.
iv
T Herrling, K Jung, E Chatelain and M Langenauer, Radical Skin/Sun Protection Factor RSF Protection against UV-induced Free Radicals, SOFW-Journal 132, 24-28 (2006).
v
T Herrling, K Jung, E Chatelain and M Langenauer, Radical Skin/Sun Protection Factor RSF Protection against UV-induced Free Radicals, SOFW-Journal 132, 24-28 (2006); K Jung, M Seifert, T
Herrling and J Fuchs, UV-generated free radicals in skin: their prevention by sunscreens and their
induction by self-tanning agents, Spectrochim. Acta Part A 69, 1423-1428 (2008); KM Hanson and RM
Clegg, Bioconvertible vitamin antioxidants improve sunscreen photo protection against UV induced ROS,
J. Cosm. Sci. 54, 589-598 (2003).
vi
http://www.aad.org/skin-care-and-safety/skin-cancer-prevention/be-sun-smart
vii
http://www.aad.org/stories-and-news/news-releases/dermatologists-can-help-separate-fact-fromfiction-for-sun-exposure-sunscreen-and-vitamin-d