PL Detail-Document #310609 −This PL Detail-Document gives subscribers additional insight related to the Recommendations published in−

PHARMACIST’S LETTER / PRESCRIBER’S LETTER June 2015

Shedding Light on Questions about Sunscreens Introduction Millions of people are treated every year for skin cancer and thousands of these individuals die.1 Around 90% of cases of skin cancer are associated with exposure to solar and artificial ultraviolet (UV) radiation.2 The FDA and Health Canada recently updated their requirements for labeling of sunscreens to help consumers know how well they’re being protected from the sun’s damaging rays. Even so, you’re sure to continue to get questions about proper sunscreen use. This document has the answers that people will want, plus more general information about sunscreen labeling.

Refresher on Sunscreen Terminology Terminology used on sunscreen labeling can be confusing to consumers and health care professionals alike. Here are common terms, both newer and some that have been used for years, with definitions to refresh the memory. MED (minimal erythemal dose): a parameter used to calculate the SPF of a sunscreen. Defined as the “minimum dose of ultraviolet radiation that produces clearly marginated erythema on the irradiated site, given as a single exposure.”1 SPF (sun protection factor): SPF describes the amount of UVB protection (i.e., protection against sunburn) that a sunscreen provides. The SPF is found by dividing the MED on protected skin by the MED on unprotected skin.1 A common misconception is that SPF tells the user how long they can stay in the sun. This isn’t necessarily true because the amount of solar exposure can vary with many factors such as time of day, cloud cover, amount of sunscreen applied, etc. In fact, people typically apply less than half the amount of sunscreen that’s recommended, which can significantly reduce protection. In general, the higher the SPF, the better the protection against sunburn. However, it is important to note that doubling the SPF does not

translate to doubling sun protection. For example, a product with SPF 15 blocks about 93% of UVB radiation and a product with SPF 30 blocks about 97% of UVB radiation.1 Rules say any product with an SPF higher than 50 will be labeled with an SPF of 50+. This is because there isn’t proof to show they protect people any better than products with SPF 50.3,4 In the U.S., implementation of this has been delayed because experts are still debating. So keep in mind you might still see products in the U.S. labeled with SPF of higher than 50. Broad spectrum. Broad spectrum means a sunscreen has passed test procedures for measuring effectiveness against both UVA and UVB radiation. These tests determine that UVA protection is proportional to UVB protection.3,4 Broad spectrum sunscreens not only protect against sunburn, but also against skin cancer and early skin aging.3,4 For example, one study shows that regular use of sunscreen slows aging of the skin in healthy middle-aged men and women.5 Labels for broad spectrum sunscreens with SPF 15 or greater are able to make these claims on their labeling.3,4 It’s important to note that non-broad spectrum sunscreens only protect against sunburn, and cannot make claims about prevention of aging or cancer.3,4 The same is true for broad spectrum sunscreens with SPF 2 to 14.3,4 Water resistant. Terms such as “waterproof” and “sweat proof” may not be used on sunscreen labeling.3,4 The correct terminology is “water resistant,” and the label must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while a person is swimming or sweating.3,4,6 This is determined based on standard testing.3 Note that no sunscreen product is able to claim more than two hours of protection without additional approval.3,4 More. . .

Copyright © 2015 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com

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Q&A About Sun Protection What’s the best general advice on sun protection? Individuals should generally be advised to use a sunscreen with SPF 15 or higher (the American Academy of Dermatology recommends SPF 30 or higher) on a regular basis and to limit time in the sun, especially between the hours of 10 AM and 2 PM when the sun’s rays are the strongest.4,7,8 (A good rule of thumb is to seek shade when your shadow is shorter than you are.) Sunscreen should be applied at least every two hours, or more often for those who are sweating or swimming.7 In addition, it should be applied 15 to 30 minutes before sun exposure, since it does not work instantly.9 Clothing should be worn to protect the body from sun as well, such as long-sleeved shirts, pants, and broad-brimmed hats.7 A lip balm with SPF 30 or higher should be used to protect the lips from sun damage.8 What’s the difference between sunscreen product formulations? FDA and Health Canada allow sunscreen formulations such as creams, gels, lotions, oils, ointments, pastes, sprays, and sticks to be marketed without individual product approvals.4,7 Individual patients may prefer specific formulations for a number of reasons. For example, a gel might be preferable for a patient with oily skin, a spray for wet skin, or a cream or oil for dry skin. Likewise, dermatologists recommend creams for the face, gels for hairy areas, and sticks for areas around the eyes. FDA is looking at sprays for safety and efficacy due to the risk of inhalation when applying these products.7,8 Health Canada requires labels to say that the spray should first be applied to hands and then spread on the body via the hands.4 This technique is especially important to remember in order to avoid accidental inhalation if sprays are applied to the face or to children.8,10 Also, remember that some sunscreen sprays (i.e., those containing alcohol) are flammable. What’s the best sun protection for infants? Babies under six months old should be kept out of direct sunlight. A small amount of sunscreen (SPF 15 or higher) may be applied to limited areas of infants under six months old if there is no way to avoid the sun. Suggest zinc oxide or titanium

dioxide as these don’t chemically bind to the skin, and may be less irritating.8,11 Lightweight clothing that covers the arms and legs and brimmed hats should also be worn by infants to protect them from sun.9 How much sunscreen should generally be applied on an adult? The general rule is to apply sunscreen liberally to all exposed skin. The average sized adult should apply a total of about one to 1.5 ounces (two to three tablespoons), or about a handful, of sunscreen per full-body application.10 This amount may need to be adjusted based on body size. Here’s a recommended distribution: one teaspoon to face and scalp and each arm, and two teaspoons to torso and each leg.10 When should sunscreens be discarded? Sunscreens are generally made to retain their original strength for up to three years from manufacture. They should be discarded by the expiration date on the package at the latest.12 Sunscreens should be kept out of direct sunlight in order to preserve their potency. A sunscreen should be discarded if it’s been exposed to high temps or if there are changes in its color or consistency.12 How well does clothing protect against sun? Tightly woven dry clothes reflect almost all UV rays. If an item is held up to the sun and allows light to pass through, it will allow UV rays to pass through to skin as well.1 In addition, wet clothes allow about half of UV rays to pass through to skin.1 Some clothing may be labeled with a UPF (ultra-violet protection factor) rating which indicates that it’s protective against UV rays. This labeling is not regulated. What if a sunscreen and insect repellent are both needed? If both a sunscreen and insect repellent are needed, separate products should be used because the sunscreen will need to be applied more frequently. The sunscreen should be applied first, then the insect repellent about 30 minutes later.13,14 Are oxybenzone and nanoparticle formulations safe? There have been concerns that oxybenzone has estrogenic effects and that sunscreens formulated with nanoparticles of titanium dioxide or zinc oxide might cause toxicity. Animal data have suggested estrogenic effects of orally administered oxybenzone. However, an unattainably large amount of sunscreen with oxybenzone would need to be applied to the More. . .

Copyright © 2015 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com

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human body to produce the same systemic exposure as in the animal studies.15 In addition, data support the fact that nanoparticles are unlikely to penetrate the skin, which would be necessary for toxicity to occur from their production of free radicals.16 Does sunscreen protect against the most deadly skin cancers? Melanoma is the most deadly skin cancer. For years it was not clear whether or not using sunscreen could help prevent melanoma, although it was proven to prevent the less dangerous squamous cell carcinomas.17 The results of a randomized controlled trial that was published in 2011 showed that regular use of sunscreen does help prevent melanoma. Regular use of an SPF 16 sunscreen for five years reduced the risk of melanoma over the following ten years by about 50%, from 22% to 11%.18,19 Does sunscreen prevent a person from getting enough vitamin D? Most people get at least some of their vitamin D through exposure to sunlight. UVB radiation converts cutaneous 7dehydrocholesterol to previtamin D3, which in turn becomes vitamin D3. People with very little sun exposure are unlikely to have adequate synthesis of vitamin D from sunlight. The role that sunscreen use might play in this is unclear. However, vitamin D can be obtained from foods or supplements if needed.8,19 Is indoor tanning safer than tanning in the sun? UV tanning beds and booths are considered carcinogenic to humans, similar to tobacco and asbestos.2 Indoor tanning exposes individuals to UVA and UVB rays similar to tanning in the sun. With indoor tanning, an individual may be exposed to high levels of UV radiation in a very short period of time. Indoor tanning is not safer than tanning in the sun.20 Unlike indoor tanning, sunless tanners actually are a safe alternative to tanning in the sun.8 However, the “tan” from a sunless tanner (or a “base tan” from tanning indoors or in the sun) isn’t likely to be very protective against skin damage from the sun. Advise individuals to continue to use sunscreen.8

Remind patients to read sunscreen labels, both front and back, to more fully understand the products they are choosing. Users of this PL Detail-Document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and internet links in this article were current as of the date of publication.

Project Leader in preparation of this PL DetailDocument: Stacy A. Hester, R.Ph., BCPS, Assistant Editor

References 1.

2. 3.

4.

5.

6.

7.

Conclusion Protection against the sun includes limiting time in the sun, wearing protective clothing, and wearing sunscreen. Recommend a water resistant, broad spectrum sunscreen with SPF of 15 or higher for most people.

8.

Crosby KM, O’Neal K. Prevention of sun-induced skin disorders. In: Krinsky DL, Ferreri SP, Hemstreet B, et al, Eds. Handbook of th Nonprescription Drugs. 18 ed. Washington, DC: American Pharmacists Association, 2015. The Big Burn. http://thebigburn.ca/. (Accessed May 7, 2015). FDA. Questions and answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. October 22, 2014. http://www.fda.gov/Drugs/ResourcesForYou/Consu mers/BuyingUsingMedicineSafely/UnderstandingO ver-theCounterMedicines/ucm258468.htm#Q6_What_are _the_main_points. (Accessed May 7, 2015). Health Canada. Sunscreen monograph. July 7, 2013. http://webprod.hc-sc.gc.ca/nhpidbdipsn/atReq.do?atid=sunscreen-ecransolaire&. (Accessed May 7, 2015). Hughes MC, Williams GM, Baker P, Green AC. Sunscreen and prevention of skin aging: a randomized trial. Ann Intern Med 2013;158:78190. DHHS. Labeling and effectiveness testing: sunscreen drug products for over-the-counter human use; delay of compliance dates. May 11, 2012. http://www.gpo.gov/fdsys/pkg/FR-2012-0511/pdf/2012-11390.pdf. (Accessed May 7, 2015). FDA. FDA sheds light on sunscreens. February 13, 2015. http://www.fda.gov/forconsumers/consumerupdates /ucm258416.htm. (Accessed May 7, 2015). American Academy of Dermatology. Sunscreen FAQs. https://www.aad.org/media-resources/statsand-facts/prevention-and-care/sunscreen-faqs. (Accessed May 7, 2015).

More. . . Copyright © 2015 by Therapeutic Research Center 3120 W. March Lane, Stockton, CA 95219 ~ Phone: 209-472-2240 ~ Fax: 209-472-2249 www.PharmacistsLetter.com ~ www.PrescribersLetter.com ~ www.PharmacyTechniciansLetter.com

(PL Detail-Document #310609: Page 4 of 4) 9.

10.

11.

12.

13.

14.

American Academy of Pediatrics. Spring break safety tips. February 24, 2015. http://www.aap.org/en-us/about-the-aap/aap-pressroom/news-features-and-safety-tips/pages/SpringBreak-Safety-Tips.aspx. (Accessed May 7, 2015). American Academy of Dermatology. Sunscreen 101: dermatologists answer burning questions about sunscreens. May 20, 2013. http://www.aad.org/stories-and-news/newsreleases/sunscreen-101-dermatologists-answerburning-questions-about-sunscreens. (Accessed May 7, 2015). Healthychildren.org. Safety & prevention. June 5, 2015. http://www.healthychildren.org/English/safetyprevention/at-play/Pages/Sun-Safety.aspx. (Accessed May 7, 2015). Gibson LE. Is sunscreen from last year still good? When does sunscreen expire? June 4, 2013. http://www.mayoclinic.com/health/sunscreenexpire/AN01968. (Accessed May 7, 2015). CDC. FAQ: insect repellent use & safety. November 14, 2013. http://www.cdc.gov/westnile/faq/repellent.html. (Accessed May 7, 2015). MedlinePlus. Bug repellent safety. April 13, 2013. http://www.nlm.nih.gov/medlineplus/ency/article/00 1969.htm. (Accessed May 11, 2015).

15. Wang SQ, Burnett ME, Lim HW. Safety of oxybenzone: putting numbers into perspective. Arch Dermatol 2011;147:865-6. 16. Nanodermatology Society. The 2011 Nanodermatology Society position statement on sunscreens. http://www.nanodermsociety.org/documents/press/ NDS_Sunscreen_Guidelines.pdf. (Accessed May 7, 2015). 17. Skin Cancer Foundation. The verdict is in: sunscreen helps prevent melanoma and other skin cancers. http://www.skincancer.org/news/sunscreen/theverdict-is-in-sunscreen-helps-prevent-melanomaand-other-skin-cancers. (Accessed May 7, 2015). 18. Bigby M, Kim CC. A prospective randomized controlled trial indicates that sunscreen use reduced the risk of developing melanoma. Arch Dermatol 2011;147:853-4. 19. National Institutes of Health. Vitamin D. November 10, 2014. http://ods.od.nih.gov/factsheets/VitaminDHealthProfessional/. (Accessed May 7, 2015). 20. CDC. Indoor tanning is not safe. February 10, 2015. http://www.cdc.gov/cancer/skin/basic_info/indoor_t anning.htm. (Accessed May 7, 2015).

Cite this document as follows: PL Detail-Document, Shedding Light on Questions about Sunscreens. Pharmacist’s Letter/Prescriber’s Letter. June 2015.

Evidence and Recommendations You Can Trust… 3120 West March Lane, Stockton, CA 95219 ~ TEL (209) 472-2240 ~ FAX (209) 472-2249 Copyright  2015 by Therapeutic Research Center

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Sunscreen.

Put it between you

and the sun.

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Staying Safe in the Sun People associate the sun with sports, lazy days at the beach, and keeping fit. But too much sun is not good. The rays of the sun, called “UV” rays, can hurt your skin. UVB rays mostly cause sunburn. UVA rays can cause early skin aging and skin cancer.

Keeping safe from the sun The best way to stay safe in the sun is to limit your time outside. The sun’s rays are the strongest between 10 AM and 2 PM. If you have to be outside, find some shade or cover your skin with dry, tightly woven clothing. Wear a wide-brimmed hat to help protect your face, head, ears, and neck. The sun can harm your eyes too. Wear sunglasses that block the UV rays from the sun. Don’t think you are safe because it is cloudy or you’re in water. Clouds only block up to 20% of UV rays and water doesn’t block any. Of course, don’t forget to wear sunscreen!

Buying a sunscreen Choosing a sunscreen can be confusing. When buying a sunscreen, use these tips:  Choose one with a sun protection factor (SPF) of 15 or higher. In general, the higher the number, the better the sunburn protection.  Choose one that is “broad spectrum.” These protect against both UVA and UVB rays.  Choose a “water-resistant” sunscreen. These stay on your skin longer if you are wet or sweating. No sunscreen is “waterproof.” Check the bottle for how often to reapply.  Avoid products that have both a sunscreen and bug repellent in one bottle. Sunscreen usually needs to be applied more often than bug repellent.

Tips for using sunscreen   

Apply plenty of sunscreen, about a handful to cover your body, 15 to 30 minutes before going out in the sun. Use sunscreen on all skin not covered by clothes. Don’t forget your nose, ears, neck, backs of hands, tops of feet, and top of head (if you don’t have much hair). Apply more sunscreen at least every 2 hours, even if you’re using a water-resistant sunscreen. Apply sunscreen more often if you are swimming or sweating.

Protecting kids from the sun Children need to be kept safe from the sun whenever they’re outside. If your baby is less than six months old, it is best to keep them out of the sun or keep them in the shade. Check with your baby’s prescriber before using a sunscreen. For older children, follow the directions on the sunscreen bottle.

What about indoor tanning? Indoor tanning isn’t safer than sunning outside. Keep in mind that a “base” tan from indoor tanning or sunning outside won’t protect you much from further skin damage from the sun.

Be safe in the sun Think about sun safety every day, not just when you’re at the pool or the beach. Regular use of a sunscreen will help reduce early skin aging and help you look younger. Plus, it will help protect you from skin cancer. [This handout may not cover all possible information. It does not replace the need for professional medical care. Always follow the instructions from your health care provider.][May 2015]

Prepared for the subscribers of Pharmacist’s Letter / Prescriber’s Letter to give to their patients. Copyright © 2015 by Therapeutic Research Center www.PharmacistsLetter.com ~ www.PrescribersLetter.com

Seguridad del sol Las personas asocian el sol con los deportes, días relajantes en la playa y mantenerse en forma. Pero demasiado sol no es bueno. Los rayos solares, llamado los rayos ultravioleta (UV), pueden dañar su piel. Los rayos UVB por la mayoría de veces causan las quemaduras del sol. Los rayos UVA pueden causar envejecimiento prematuro de la piel y cáncer de piel.

Mantenerse seguro del sol La mejor manera de mantenerse seguro del sol es limitar su tiempo afuera. Los rayos de sol son más fuertes entre las 10 de la mañana y las 2 de la tarde. Si usted necesita estar afuera, buscar algo de sombra o cubrir su piel con ropa de tejido apretado. Use un sombrero de ala ancha para que ayude a proteger su cara, cabeza, orejas y cuello. El sol puede dañar también sus ojos. Use lentes de sol que bloquean los rayos UV del sol. No crea que esté seguro porque esta nublado o está en el agua. Las nubes sólo bloquean hasta un 20% de los rayos UV y el agua no bloquea. Por supuesto, ¡no se olvide de usar bloqueador solar!

Comprar filtros solares Elegir un protector solar puede ser confuso. Cuando compre un producto para proteger del sol, use estos consejos: • Escoja una con factor de protección solar (FPS) de 15 o más. En general, el número más grande, lo mejor que puede proteger de los rayos del sol. • Escoja una que sea “rango amplio”. Estos protegen sobre los dos tipos de rayos de UVA y UVB. • Elija un protector solar que sea "resistente al agua". Estos se retienen en su piel por más tiempo si esta mojado o sudando. No filtros solares es "impermeable". Observe la botella para mirar que tan seguido se debe aplicar. • Evite los productos que tengan los dos protector solar y repelentes de insectos. Protector solar generalmente debe aplicarse más a menudo que el repelente.

Consejos para usar su protector solar • • •

Aplique una buena cantidad de protector solar, aproximadamente un puñado para cubrir su cuerpo, de 15 a 30 minutos antes de salir en el sol. Use protector solar en toda la piel que no esté cubierta por ropa. No olvide su nariz, orejas, cuello, dorso de manos, tapas de pies y parte superior de la cabeza (si no tienes mucho pelo). Aplique más protector solar por lo menos cada 2 horas, incluso si está usando un protector solar resistente al agua. Aplique el protector solar más a menudo si está nadando o sudando.

Proteger los niños del sol Los niños necesitan mantenerse a salvo del sol cuando estén fuera. Si su bebé tiene menos de seis meses, es mejor mantenerlos fuera del sol o mantenerlos en la sombra. Consulte con su pediatra de su bebé antes de usar un protector solar. Para niños mayores, siga las instrucciones en la botella.

¿Qué tal broncearse adentro? Broncearse adentro no es más seguro que broncearse afuera. Mantenga en mente que un poco de broncearse adentro es igual como afuera no lo protege del sol para daños en la piel en el futuro.

Manténgase seguro en el sol Piense en su seguridad del sol todos los días, no sólo cuando este en la piscina o la playa. El uso regular de un protector solar le ayudará a reducir el envejecimiento prematuro de la piel y ayuda que luzca más joven. Además, ayudará a protegerle contra cáncer de piel. [Este panfleto puede no tener toda la información posible. También no reemplaza la necesidad de atención médica profesional. Siempre siga las instrucciones de su profesional de atención de la salud.] [Mayo 2015] Prepared for the subscribers of Pharmacist’s Letter / Prescriber’s Letter to give to their patients. Copyright © 2015 by Therapeutic Research Center www.PharmacistsLetter.com ~ www.PrescribersLetter.com