Introduction In 2019, the U.S. Food and Drug Administration (FDA) proposed significant updates to sunscreen regulations to ensure consumer safety and efficacy of these products. This comprehensive guide outlines the key points of the 2019 FDA sunscreen update, including changes in active ingredients, product labeling, and safety testing. Key Points of the 2019 FDA Sunscreen Update 1. Evaluation of Active Ingredients The FDA evaluated 16 active ingredients commonly used in sunscreens to determine their safety and efficacy. The findings were categorized as follows: Generally Recognized as Safe and Effective (GRASE): Zinc Oxide and Titanium Dioxide: These mineral sunscreens are considered safe and effective. Insufficient Data for GRASE Determination: Avobenzone, Octinoxate, Oxybenzone, and 9 Other Ingredients: The FDA found insufficient data to determine their safety and called for additional research. Not Generally Recognized as Safe and Effective: PABA and Trolamine Salicylate: These ingredients were deemed not safe and effective and are proposed to be eliminated from the sunscreen market. 2. Labeling Requirements The FDA proposed updates to sunscreen labeling to help consumers make informed choices: Broad Spectrum Labeling: Only sunscreens that provide protection against both UVA and UVB rays and meet the FDA’s standards can be labeled as "Broad Spectrum." SPF Labeling: The maximum SPF value on labels should be capped at 60+. Products with SPF values higher than 60 should not claim to offer significantly greater protection. Water Resistance Claims: Labels must specify whether the sunscreen is water-resistant for 40 or 80 minutes. Claims like “waterproof” or “sweatproof” are prohibited. 3. Safety Testing and Data Requirements The FDA requested additional safety data on certain chemical sunscreen ingredients to better understand their absorption into the skin and potential long-term effects. The focus is on ensuring that these ingredients do not cause harm when used as directed. 4. Product Forms and Dosage Forms The update addressed various forms of sunscreen products: Sprays: Require additional testing to ensure they are safe and effective and to confirm that inhalation risks are minimized. Powders: Considered not GRASE due to insufficient data on safety and efficacy. Other Forms (wipes, towelettes, body washes, shampoos): Proposed not to be marketed as sunscreens due to insufficient data on safety and efficacy. 5. Reef-Safe Sunscreens While the FDA’s update does not directly address the environmental impact of sunscreens, there has been increasing concern about the effects of certain sunscreen ingredients on coral reefs and marine life. Ingredients like oxybenzone and octinoxate have been banned in places like Hawaii due to their harmful effects on coral reefs. Impact on Consumers and Manufacturers For Consumers Informed Choices: Consumers can make better decisions with clear labeling on UVA/UVB protection, SPF values, and water resistance. Safety Assurance: The FDA’s rigorous evaluation of active ingredients ensures that products on the market are safe for use. Environmental Considerations: Awareness of reef-safe sunscreens is crucial for consumers who want to minimize their environmental impact. For Manufacturers Compliance: Sunscreen manufacturers must comply with updated labeling and safety testing requirements. Research and Development: Additional research may be necessary for manufacturers to prove the safety and efficacy of certain chemical ingredients. Innovation: The need for safer and more effective sunscreens may drive innovation in the development of new ingredients and formulations. Conclusion The 2019 FDA sunscreen update represents a significant step toward ensuring the safety and effectiveness of sunscreens available in the market. By understanding these changes, consumers can make informed choices to protect their skin while manufacturers work to comply with the new regulations. Staying informed about these updates helps everyone contribute to better skin health and environmental protection.
