FDA's sunscreen recommendations

October 1, 2014

The need to protect the skin from excessive sun exposure from ultraviolet radiation (UVR) is now well established based on studies showing a clear causal link between excessive UVR exposure and damage to the skin that raises the risk of skin cancer and leads to premature aging.


The need to protect the skin from excessive sun exposure from ultraviolet radiation (UVR) is now well established based on studies showing a clear causal link between excessive UVR exposure and damage to the skin that raises the risk of skin cancer and leads to premature aging.1 Despite this known causal link, the rate of skin cancer continues to grow at a rapid pace.

Data show that the incidence of the most serious type of skin cancer, melanoma, has been doubling every 10 years in many countries and is expected to continue to rise over the next 10 to 20 years.1 In the United States, skin cancer is the most common cancer and it is estimated that 1 in 5 persons will be diagnosed with a skin cancer during his or her lifetime.1

Protecting children against sun overexposure is particularly important to prevent or reduce the lifetime chance of developing skin cancer and other skin damage. Epidemiologic data show a higher incidence of melanoma in persons with a history of sunburns during childhood, and data from a prospective, population-based study indicate that more than 50% of children experience a sunburn before age 11 years followed by another sunburn a few years later.2

Pediatricians can play a pivotal role in reducing the adverse effects of sun damage by educating children and their parents on ways to avoid overexposure to the sun, including the appropriate and regular use of sunscreen. When used along with other primary preventive measures, the appropriate use of sunscreen can provide the necessary protection to prevent and reduce the rising incidence of skin cancer.2

This article is a brief overview of current efforts to provide guidance on the proper use of sunscreen in children. The article first describes recent efforts by the US Food and Drug Administration (FDA) to provide guidance to consumers on how to evaluate the effectiveness of different sunscreen products based on mandating new regulations to sunscreen manufacturers on labeling requirements. Pediatricians and other healthcare providers can help their patients understand these labels to ensure the appropriate and best selection and use of these products.

Along with sunscreen use, the FDA and other organizations highlight the importance of using other primary preventive measures to provide the best protection against the sun as described. Finally, the article briefly mentions several issues that have raised some concerns regarding the potential harm of sunscreens, including systemic toxicity and vitamin D deficiency, as well as issues that await more clear FDA direction such as the safety of sunscreen sprays. 



Recent FDA guidance on sunscreen use

With the growing number of sunscreens on the market with varying information on sun protection claims, the FDA proposed new regulations to sunscreen manufacturers to establish standards for testing the effectiveness of over-the-counter (OTC) sunscreen products.3 Implemented in July 2012, the new regulations require that all sunscreen products be labeled to provide accurate information on the product’s effectiveness.4,5 Key terms and their descriptions used in labeling based on these new FDA regulations are listed in Table 1.5,6

Important to highlight is the label telling consumers that the product reduces the risk of all types of sun damage, including skin cancer. These products are labeled as broad spectrum with a sun protection factor (SPF) of 15 or greater, and the labeling further indicates that: “If used as directed with other sun protection measures, this product reduces the risk of skin cancer and early skin aging, as well as helps prevent sunburn.”5

Preventive measures used with sunscreens

Along with selecting an appropriate sunscreen to prevent sun damage, children and their parents should be advised to follow several simple instructions that can minimize the risk of sun damage. Several organizations, including the FDA, emphasize the need for adhering to other preventive methods along with sunscreen use to provide the best sun protection. Most of these measures prioritize the need to reduce sun exposure particularly during midday when UV intensity is at its peak and emphasize the need to cover up with appropriate clothing while in the sun; regular use of ample sunscreen while in the sun; and application of a sunscreen sufficient to protect the skin. Table 2 lists recommendations for primary prevention of overexposure to the sun by the FDA, the Centers for Disease Control and Prevention, and the American Academy of Pediatrics.6-9



Is sunscreen safe?

Several concerns have been raised about the use of sunscreens, particularly when used long term. These include the effect of sunscreen use on vitamin D deficiency, systemic toxicity, increased risk of melanoma, and on hormones. Although clinical data are lacking to provide a definitive answer to some of these concerns, the potential risk of these issues needs to be weighed against the well-established benefits of sun protection. Table 3 provides some information on what is known to date.4,10

Issues needing further clarification

Clarification by the FDA on a number of issues is pending. Among these is the use of sunscreen spray products. Because these sprays are applied differently from other sunscreen products, the FDA is requesting additional information from their manufacturers to determine efficacy as well as evaluate safety concerns regarding inhaling the sprays.6 As of July 2014, the FDA recommends not to use the sprays in children until its final review.11

Another pending issue is the value of an SPF greater than 50. Currently the FDA has proposed a regulation that would limit the maximum SPF value to SPF 50+ on product labeling.6

Finally, new legislation, just passed by the US Senate on September 17, 2014, and anticipated to be passed by the House of Representatives and signed into law by the President, is intended to expedite testing of new ingredients for future sunscreens. The Sunscreen Innovation Act will require the FDA to respond more quickly to pending OTC sunscreens with new active ingredients submitted for review and approval.12 Table 4 lists ingredients currently approved by the FDA for sunscreen products.5















1. Nahar VK. Skin cancer prevention among school children: a brief review. Cent Eur J Public Health. 2013;21(4):227-232.

2. Quatrano NA, Dinulos JG. Current principles of sunscreen use in children. Curr Opin Pediatr. 2013;25(1):122-129.

3. US Food and Drug Administration. Questions and answers: FDA announces new requirements for over-the-counter (OTC) sunscreen products marketed in the U.S. Available at: http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandingover-the-countermedicines/ucm258468.htm. June 23, 2011. Updated August 30. 2013. Accessed September 24, 2014.

4. Hellwig TR, Gripentrog EM, Templeton KS. Shining the light on sunscreen. US Pharmacist website..Available at: http://www.uspharmacist.com/content/d/featured%20articles/c/33439/. Published April 23, 2012. Accessed September 24, 2014.

5. Food and Drug Administration, Department of Health and Human Services. Labeling and effectiveness testing: sunscreen drug products for over-the-counter human use. Final rule. Fed Regist. 2011;76(117):35620-35665.

6. US Food and Drug Administration. FDA sheds light on sunscreens. Available at: http://www.fda.gov/Forconsumers/consumerupdates/ucm258416.htm. Updated May 17, 2012. Accessed September 24, 2014.

7. US Food and Drug Administration. Should you put sunscreen on infants? Not usually. Available at: http://www.fda.gov/forconsumers/consumerupdates/ucm309136.htm. Updated May 6, 2014. Accessed September 24, 2014.

8. Centers for Disease Control and Prevention. How can I protect my children from the sun? Available at: http://www.cdc.gov/cancer/skin/basic_info/children.htm. Reviewed December 12, 2013. Updated June 24, 2014. Accessed September 24, 2014.

9. American Academy of Pediatrics. Sun and water safety tips. Available at: http://www.aap.org/en-us/about-the-aap/aap-press-room/news-features-and-safety-tips/Pages/Sun-and-Water-Safety-Tips.aspx. Accessed September 24, 2014.

10. Sambandan DR, Ratner D. Sunscreens: an overview and update. J Am Acad Dermatol. 2011;64(4):748-758.

11. Consumer Reports. Don’t spray sunscreens on kids, at least for now. Available at: http://www.consumerreports.org/cro/news/2011/07/don-t-spray-sunscreens-on-kids-at-least-for-now/index.htm. Published July 2011. Updated July 2, 2014. Accessed September 24, 2014.

12. Congress.gov. S.2141-Sunscreen Innovation Act.  Available at: https://beta.congress.gov/bill/113th-congress/senate-bill/2141. Accessed September 24, 2014. 


Ms Nierengarten, a medical writer in St. Paul, Minnesota, has over 25 years of medical writing experience, coauthoring articles for Lancet Oncology, Lancet Neurology, Lancet Infectious Diseases, and Medscape. The author has nothing to disclose in regard to affiliations with or financial interests in any organizations that may have an interest in any part of this article.