From the Guidelines
The FDA recommends using broad-spectrum sunscreens with a sun protection factor of 15 or greater to protect against UV A and UV B radiation, and reduce the risk of skin cancer and early skin aging, as stated in their guidelines 1.
Key Recommendations
- The U.S. Food and Drug Administration has determined that broad-spectrum sunscreens with a sun-protection factor of 15 or greater protect against both UV-A and UV-B radiation and reduce the risk for skin cancer and early skin aging, if used as directed 1.
- Consumers should look for broad-spectrum sunscreens with SPF 30 or higher, apply 1 ounce (about a shot glass full) for full-body coverage, and reapply every two hours or after swimming/sweating.
- Mineral sunscreens containing zinc oxide or titanium dioxide are recommended for those with sensitive skin or environmental concerns, as some chemical filters have shown potential for coral reef damage and hormonal effects.
Regulatory Changes
- The FDA now requires more rigorous testing of active ingredients and has reclassified only zinc oxide and titanium dioxide as "generally recognized as safe and effective" (GRASE) 1.
- Chemical filters like oxybenzone and avobenzone require additional safety data, though they remain available while under review.
- Broad-spectrum protection against both UVA and UVB rays is now mandatory for sunscreens claiming to prevent skin cancer and premature aging.
- SPF labeling has been standardized with a maximum of "SPF 50+" to prevent misleading claims.
- Water resistance must be specifically tested and labeled as either 40 or 80 minutes of protection.
Education and Prevention
- The Community Preventive Services Task Force recommends education and policy interventions for the prevention of skin cancer, including community-based communications and policy and regulation to increase preventive behaviors 1.
- The U.S. Food and Drug Administration has consumer education materials on the dangers of indoor tanning and the use and effectiveness of broad-spectrum sunscreens (www.fda.gov/sunscreen) 1.
From the FDA Drug Label
Directions ■ apply liberally 15 minutes before sun exposure ■ children under 6 months of age: Ask a doctor ■ Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: ■ limit time in the sun, especially from 10 a.m. - 2 p.m. ■ wear long-sleeved shirts, pants, hats, and sunglasses reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating Uses ■ helps prevent sunburn ■ If used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
The main safety measures for sunscreen use, as indicated in the labels, include:
- Using a Broad Spectrum SPF value of 15 or higher
- Limiting time in the sun, especially from 10 a.m. - 2 p.m.
- Wearing protective clothing, such as long-sleeved shirts, pants, hats, and sunglasses
- Reapplying sunscreen at least every 2 hours
- Using a water-resistant sunscreen if swimming or sweating These measures can help decrease the risk of skin cancer and early skin aging caused by the sun, as stated in the drug labels 2 and 2.
From the Research
Sunscreen Safety and Regulations
- The safety of sunscreens has been a topic of discussion in recent years, with studies focusing on the potential risks and benefits of various ingredients 3, 4.
- Inorganic UV filters such as zinc oxide (ZnO) and titanium dioxide (TiO2) have been found to be effective in providing broad-spectrum protection against UVA and UVB radiation 5, 6.
- However, there are concerns about the potential environmental and human health impacts of these ingredients, particularly when used in nanoparticle form 4, 7.
- Studies have shown that ZnO and TiO2 nanoparticles can be absorbed into the skin, but the risk of toxicity is considered low 4, 7.
- The use of ZnO and TiO2 in sunscreens is considered a safe alternative to organic UV filters, which have been linked to environmental and human health concerns 7.
Regulatory Developments
- Regulatory agencies have established guidelines for the use of UV filters in sunscreens, including requirements for labeling and testing 3.
- The US Food and Drug Administration (FDA) has established a rule that sunscreens must provide a minimum level of protection against UVA radiation, which is at least one-third of the overall sun protection factor 4.
- The European Union has also established regulations for the use of UV filters in sunscreens, including restrictions on the use of certain ingredients 7.
Future Directions
- Further research is needed to fully understand the potential risks and benefits of UV filters in sunscreens, particularly in relation to environmental and human health impacts 3, 4.
- The development of new, safer UV filters is an area of ongoing research, with a focus on finding alternatives to traditional ingredients 7.
- Education and awareness campaigns are also important for promoting the safe use of sunscreens and encouraging consumers to make informed choices about their sun protection products 7.