Sunscreen compliance in the U.S. may be on the edge of its most significant update in over two decades. On June 3, 2025, lawmakers introduced the SAFE Sunscreen Standards Act (H.R.3686), a bipartisan bill that aims to modernize how the FDA reviews and approves sunscreen active ingredients. 

This matters because no new sunscreen ingredients have been approved by the FDA since 1999. If you manufacture, import, or label sunscreen products, this could shift how quickly and effectively your products enter the U.S. market. Keep reading to find out what this means for your business and how you can prepare. 

What is the SAFE Sunscreen Standards Act? 

The SAFE Sunscreen Standards Act, short for Supporting Accessible, Flexible, and Effective Sunscreen Standards, was introduced in the House of Representatives by Representatives Dr. John Joyce, Debbie Dingell, Dave Joyce, and Deborah Ross. The bill proposes amendments to the Federal Food, Drug, and Cosmetic Act to improve how sunscreen active ingredients are reviewed and approved. 

This legislation was introduced in response to mounting concerns that current FDA regulations are outdated and restrictive. Because sunscreens are classified as over-the-counter (OTC) drugs in the U.S., any new UV filter must undergo a lengthy New Drug Application (NDA) process, which often takes years. This has prevented innovative and globally recognized ingredients from entering the market. 

As a result, many promising ingredients remain stuck in regulatory limbo, while some ingredients currently in use have not been fully assessed for safety. The bill aims to fix this by creating a faster, more transparent review process that still prioritizes public health and safety. 

Key provisions of the SAFE Sunscreen Standards Act 

The U.S. currently allows only 16 active sunscreen ingredients, while regions like the EU permit more than 30. Many globally accepted ingredients remain stuck in FDA limbo, leaving companies with limited options and longer timelines. So, here’s what the bill proposes: 

• A streamlined pathway for reviewing and approving sunscreen active ingredients. 
• An emphasis on non-animal testing methods, supporting alternative evidence models. 
• A requirement for the FDA to deliver a formal report to Congress on its progress implementing new testing standards. 

If passed, this legislation would remove long-standing regulatory bottlenecks and improve sunscreen ingredient compliance in the U.S. market. 

Why this matters for sunscreen compliance 

For businesses looking to enter or expand in the U.S. OTC market, sunscreen compliance is a critical barrier. Products containing active ingredients not currently approved by the FDA are classified as unapproved new drugs, making them subject to warning letters, import refusals, or recalls. 

The new bill could bring several important changes. It may lead to faster ingredient approvals, particularly for companies using internationally recognized sunscreen actives.  

Additionally, if the FDA begins accepting more alternative testing methods, businesses could benefit from reduced costs and quicker product registration timelines.  

The requirement for a formal Congressional report may also encourage greater transparency and predictability in the approval process, supporting more confident planning for product launches. 

What sunscreen brands and manufacturers should do next 

Although the SAFE Sunscreen Standards Act is not yet law, it’s a strong signal that regulatory change is on the horizon. Companies operating in the OTC space should start evaluating how these changes could impact their portfolio. Some actions you can take now include: 

• Reviewing your current ingredients and formulations for FDA alignment. 
• Assessing your product claims and labels to ensure full FDA and OTC drug monograph compliance. 
• Consulting regulatory experts to help you navigate pre-market pathways if your ingredients are not currently monograph-listed. Our team at QSS can guide you through these steps and keep you updated as the legislation progresses.