In light of the recent FDA press release regarding testing and labeling of sunscreens, I have had numerous questions from patients, friends, and family members regarding sunscreen usage: what is safe? what sunscreen would you recommend? are sunscreen ingredients harmful to me or my children?
Here is the rundown regarding the recent reports:
Sunscreens are regulated by the US FDA as over the counter drugs, rather than cosmetics; in most other countries, sunscreens are regulated in the same category as cosmetics
In 1978, the FDA began to regulate sunscreen in the US. This included an advisory panel that insured that the 21 active sunscreen ingredients that were listed were safe and effective; additionally, regulations were made regarding labeling and determination of sun protection factor (SPF).
In 1999, the 21 safe and effective sunscreen ingredients were narrowed down to 16. Further labeling requirements, including a maximum protective factor of SPF 30 were enacted.
In 2011, the same 16 safe and effective sunscreen ingredients were listed, and testing methods to determine broad-spectrum coverage and water-resistance were established. The maximum SPF increased to 50+; sunscreens were no longer allowed to make labeling claims of being “waterproof” or “all-day protective.”
Over the past couple of decades, sun-protective habits have changed. In the 1970s and 1980s, sunscreen usage was often limited to beach vacations or the occasional all-day sporting event. In more recent years, we have developed a better understanding of the link between sunburns and sun exposure with skin cancer risk. Additionally, the known effects of sun exposure on photoaging of the skin encourages many to practice daily sun protective measures in the quest for delaying the aging process and keeping skin youthful and healthy in appearance. This knowledge has driven a change in sun-protective behavior with many individuals using sunscreen daily. And the sunscreen industry has responded to consumer concerns by developing sunscreen products with broad-spectrum (UVA and UVB) protection and higher SPFs. The refinement of effective sunscreen research and development means that penetration of sunscreen ingredients has evolved…so if we are getting more penetration of “stronger” sunscreen ingredients, could this lead to toxicity within our bodies? The media quickly delved into this topic, utilizing limited and early research to suggest that sunscreen use could lead to changes in hormones, effect on reproduction, and cancer.
In 2016, the FDA outlined requirements for establishing over the counter safe and effective sunscreen ingredients; these included safety testing, cancer and reproductive testing in animals, and confirmation of safety in children. Although many of these recommendations were already implemented by sunscreen manufacturers, one significant change with this ruling was the requirement for human absorption studies; i.e., when you apply a sunscreen to your skin, how much of it is absorbed? This, of course, depends on the total body surface area to which it is applied, the vehicle in which the active sunscreen ingredient is packaged, and the absorption properties of the actual sunscreen ingredient. These studies will be costly and will likely be limited to a finite number of active sunscreen ingredients; they could take many years to complete. The end result is a probable narrowing of available sunscreen ingredients from which consumers may choose and a higher cost for those sunscreens based on supply and demand.
Here are the current proposals:
- Only 2 active sunscreen ingredients, zinc oxide and titanium dioxide, are currently considered safe and effective.
- Sprays, oils, lotions, creams, gels, pastes, ointments, butters, and sticks are approved; powders require further investigation
- Maximum SPF will increase to 60+
- Labeling will require listing the active sunscreen ingredient on the front of the package/bottle
- SPF 15 or higher is required to provide broad-spectrum coverage consistent with SPF
Bottom line (Dr. Casey’s recommendations): When applying sunscreen to large areas of skin, stick with safe and effective ingredients: I prefer zinc oxide due to its comprehensive broad-spectrum coverage (UVA and UVB protection) but titanium dioxide is also effective. Be knowledgeable regarding sunscreen additives that may be irritating or sensitive to the skin. Wide-brimmed hats and sun-protective clothing are excellent ways to protect your skin without the worry of sunscreen absorption.
And finally, protecting your skin from the sun has proven and established benefit in the prevention of skin cancer, the most prevalent cancer in the United States.
Much of the information in this post was obtained from the excellent article “Sunscreen Regulations and Advice for Your Patients” by Vincent DeLeo MD in the May 2019 issue of Cutis (vol 103 No 5 pp 251-253)