Dear FDA Officials,

I am submitting this petition to request that the U.S. Food and Drug Administration (FDA) reclassify sunscreens as cosmetics, rather than over-the-counter (OTC) drugs, and adopt a regulatory approach similar to that of the United Kingdom (UK) and the European Union (EU).

 

I. The Problem: Outdated and Overly Restrictive U.S. Sunscreen Regulations

 

In the United States, sunscreens are classified as OTC drugs, subjecting them to the FDA’s monograph system. This has significantly limited innovation and prevented Americans from accessing newer, more effective sun protection technologies. The last major update to FDA-approved sunscreen ingredients was in 1999, and since then, no new UV filters have been approved, despite advancements in sun protection science worldwide.

 

In contrast, the UK and EU regulate sunscreens as cosmetics, allowing for faster adoption of new, effective, and safe UV filters while maintaining rigorous safety standards. This outdated regulatory framework in the U.S. has left American consumers at a disadvantage, forcing them to rely on older and potentially less effective sunscreen formulations than those available in the UK, EU, South Korea, and other regions.

 

II. Comparison of Approved Sunscreen Filters: U.S. vs. UK

 

The FDA currently allows only 16 UV filters, while the UK (formerly following EU guidelines) allows over 30 UV filters, including many that offer superior protection with better cosmetic appeal. Some examples include:

 

Sunscreen Filter Approved in the U.S. (FDA)? Approved in the UK? Results listed in order, USA vs UK  

Avobenzone ✅ Yes ✅ Yes UVA protection but unstable without stabilizers

Oxybenzone ✅ Yes ❌ No (Banned in many EU countries) Concerns over hormone disruption and coral reef damage

Octinoxate ✅ Yes ❌ No (Restricted due to environmental concerns) UVB protection but linked to coral bleaching

Tinosorb S ❌ No ✅ Yes Broad-spectrum, photostable, excellent UVA/UVB protection

Tinosorb M ❌ No ✅ Yes Hybrid (organic/inorganic) filter, strong UVA/UVB protection

Mexoryl SX (Ecamsule) ❌ No (Only in specific L’Oréal products) ✅ Yes Superior UVA protection, highly stable

Mexoryl XL ❌ No ✅ Yes Broad-spectrum, highly photostable

Uvinul A Plus ❌ No ✅ Yes Strong UVA protection, stable

Uvinul T 150 ❌ No ✅ Yes High UVB absorption, very stable

 

These advanced filters, available in the UK but not in the U.S., offer better UVA protection, improved stability, and superior cosmetic elegance (e.g., non-greasy, lightweight formulations). They have undergone extensive safety testing in Europe and other markets, yet remain unavailable to American consumers due to the FDA’s outdated approval process.

 

III. The Need for Regulatory Change

 

The U.S. sunscreen market is currently constrained by an outdated approval system that prevents access to the best sun protection available globally. Reclassifying sunscreens as cosmetics, as done in the UK, would:

 1. Allow Faster Approval of New, Safer, and More Effective UV Filters – The FDA’s monograph process is too slow, delaying innovations that could reduce skin cancer risk.

 2. Improve Consumer Choice and Sunscreen Use – Many Americans avoid sunscreen due to greasy textures, white cast, or irritation from old formulations. Allowing UK-approved filters would lead to more cosmetically elegant options, increasing compliance and sun safety.

 3. Maintain High Safety Standards – The UK and EU have strict safety evaluations for cosmetics, proving that newer UV filters can be both effective and safe. The FDA should follow this evidence-based approach.

 4. Reduce Environmental Harm – Many FDA-approved filters like oxybenzone and octinoxate have been banned in the UK/EU due to coral reef damage. Newer alternatives like Tinosorb and Mexoryl offer safer, more sustainable options.

 

IV. Proposed Action

 

I respectfully urge the FDA to take the following actions:

 1. Reclassify sunscreens as cosmetics, aligning with UK and EU standards, instead of continuing to regulate them as OTC drugs.

 2. Expedite the approval process for modern UV filters that have already been extensively tested and approved in the UK/EU.

 3. Allow formulators to use a broader range of safe and effective filters without requiring an extensive New Drug Application (NDA), which is a major roadblock under the current system.

 

V. Conclusion

 

Skin cancer rates continue to rise in the U.S., yet American consumers are denied access to the best sunscreen technologies available globally due to outdated FDA regulations. By aligning with the UK and EU’s cosmetic-based sunscreen regulation model, the FDA can increase sunscreen innovation, improve public health, and provide consumers with superior sun protection options.

 

I urge the FDA to take immediate action to modernize U.S. sunscreen regulations. Thank you for your attention to this critical issue. We look forward to your response.