Case Study: Reformulating a SPF50+ Serum for EU Compliance Without Sacrificing Texture
The Challenge of Reformulating SPF for EU Compliance
Sunscreen formulation is one of the most complex product categories in skincare. With stringent global regulations, ingredient restrictions, and stability challenges, brands must carefully balance UV protection, safety, texture, and consumer expectations.
When a U.S.-based skincare brand sought to launch their best-selling SPF50+ serum in the European market, they faced a major challenge: EU sunscreen regulations differ significantly from U.S. FDA guidelines, requiring a complete reformulation. The goal was to achieve:
✔ Full compliance with EU Cosmetic Regulation (EC 1223/2009)
✔ Broad-spectrum SPF50+ protection with EU-approved filters
✔ A lightweight, fast-absorbing texture similar to the U.S. version
✔ Preservative stability and long shelf life
This case study explores how our R&D team successfully reformulated the product for the EU market while preserving the serum’s lightweight texture, non-greasy feel, and high efficacy.
Why Sunscreen Reformulation for the EU Is Challenging
1. Different Regulatory Standards for SPF Filters
- The U.S. FDA regulates sunscreens as over-the-counter (OTC) drugs, limiting approved UV filters to a fixed monograph list.
- The EU (Cosmetic Regulation EC 1223/2009) allows a wider range of UV filters, requiring in-vivo and in-vitro testing for UVA & UVB efficacy.
- Many U.S. sunscreens contain filters like oxybenzone and octinoxate, which are restricted or banned in the EU due to environmental concerns.
2. Maintaining a Lightweight, Serum-Like Texture
- Traditional SPF50+ formulations tend to be thicker due to higher UV filter concentrations.
- Reformulating for EU compliance required alternative emulsifiers, silicones, and stabilizers to retain the original lightweight feel.
3. Stability & Photostability Concerns
- High-SPF products degrade faster if filters are not properly stabilized.
- EU standards require rigorous photostability testing to ensure sunscreens remain effective after UV exposure.
4. Preservative & Allergen Restrictions
- The EU bans or restricts over 1,300 ingredients, compared to only 30 banned in the U.S.
- Reformulation had to exclude phenoxyethanol (limited to 1%), certain parabens, and common allergens.
Step 1: Identifying EU-Compliant UV Filters
Original U.S. Formulation – Not EU-Compliant
✔ Avobenzone (UVA protection)
✔ Homosalate (UVB protection)
✔ Octisalate & Octocrylene (Secondary UVB filters)
❌ Oxybenzone & Octinoxate (Restricted in the EU)
New EU-Compliant SPF Filter System
✔ Tinosorb S (Broad-spectrum, photostable)
✔ Uvinul A Plus (Strong UVA filter, photostable)
✔ Uvinul T 150 (High-performance UVB protection)
✔ Ensulizole (Water-soluble UVB filter, lightweight texture)
This new combination provided:
✔ SPF50+ protection meeting ISO 24444 standards
✔ UVA-PF meeting EU’s mandatory 1:3 UVA/UVB ratio
✔ Superior photostability without needing avobenzone stabilizers
Step 2: Reformulating for a Lightweight Texture
One of the biggest consumer complaints about high-SPF products is that they can feel thick, greasy, or leave a white cast. Our goal was to maintain the silky, fast-absorbing texture of the original serum while incorporating new EU-approved filters.
Key Adjustments to the Formulation Base:
| Component | U.S. Version | EU Version | Function |
|---|---|---|---|
| UV Filters | Octinoxate, Homosalate | Tinosorb S, Uvinul A Plus | Broad-spectrum protection |
| Emulsifiers | PEG-100 Stearate | Polyglyceryl-10 Laurate | Lightweight, skin-friendly |
| Texture Enhancer | Cyclopentasiloxane | Dimethicone Crosspolymer | Silkier feel, fast absorption |
| SPF Boosting Agents | None | Acrylates Copolymer | Improves SPF efficacy without heaviness |
✔ Reduced oil phase from 18% to 12% to prevent greasiness.
✔ Replaced PEG-based emulsifiers with biodegradable alternatives to meet EU clean beauty standards.
✔ Enhanced spreadability by incorporating a silicone elastomer gel, giving the serum a dry-touch finish.
Step 3: Stability & Photostability Testing
After reformulation, the product underwent rigorous stability and photostability testing to ensure:
✔ UV filters remain active after sun exposure
✔ No phase separation or texture degradation at high temperatures
✔ Packaging compatibility (no filter migration or crystallization)
Key Stability Test Results
| Test Type | Duration | Result |
|---|---|---|
| Accelerated Stability (40°C, 75% RH) | 12 weeks | No separation or oxidation |
| Freeze-Thaw Cycling | 6 cycles | Maintained original viscosity |
| UV Exposure (ISO 24443) | Simulated 5 hours of sun exposure | No filter breakdown |
Final testing showed that the reformulated EU version maintained SPF50+ protection for 24 months, meeting EU stability & photoprotection requirements.
Step 4: Regulatory Compliance & Claims Validation
To legally sell sunscreen in the EU, brands must comply with:
✔ SPF & UVA Testing – ISO 24444 & ISO 24443 methods for SPF and UVA-PF verification.
✔ Product Information File (PIF) – Safety reports, stability tests, and efficacy data.
✔ No misleading marketing claims – Claims like "waterproof" are banned in the EU (must use "water-resistant" instead).
✔ Packaging & Labeling Compliance – Must display the UVA logo, usage instructions, and batch traceability.
Final Compliance Status: ✅ Approved for EU sale under Regulation EC 1223/2009
Results: Successful Launch of an EU-Compliant SPF50+ Serum
The reformulated SPF50+ serum successfully launched in France, Germany, and Italy, maintaining its:
✔ Lightweight, serum-like texture with no white cast
✔ SPF50+ broad-spectrum protection
✔ EU regulatory compliance with photostable UV filters
✔ Vegan, cruelty-free, and microplastic-free certification
Consumer Feedback (Post-Launch Surveys, 5,000 Users):
| Metric | U.S. Version Satisfaction (%) | EU Version Satisfaction (%) |
|---|---|---|
| Texture & Absorption | 92% | 95% |
| Non-Greasy Feel | 88% | 94% |
| No White Cast | 90% | 97% |
| Overall Satisfaction | 91% | 96% |
Retail & Wholesale Impact:
✔ First 25,000-unit batch sold out within 3 weeks.
✔ Expanded to 5 additional European retailers.
✔ Increased overall brand revenue by 32% in 6 months.
Key Takeaways for Brands Reformulating SPF for the EU
1. Choose EU-Approved UV Filters
✔ Replace U.S.-only filters with Tinosorb, Uvinul, and Ensulizole for compliance.
✔ Ensure filters provide broad-spectrum and photostable protection.
2. Maintain Texture & Performance with Smart Ingredient Swaps
✔ Use silicone elastomers, lightweight esters, and biodegradable emulsifiers.
✔ Reduce oil phase to prevent heaviness and greasiness.
3. Validate Stability & Regulatory Compliance Early
✔ Perform ISO 24444 & 24443 SPF testing to verify claims.
✔ Ensure PIF documentation is ready before EU market entry.
Reformulation Without Compromise
Reformulating SPF for EU compliance doesn’t have to mean sacrificing texture, performance, or consumer appeal. With strategic UV filter selection, texture optimization, and rigorous testing, brands can successfully expand into new markets while maintaining product excellence.
Want to reformulate your SPF product for global compliance? Let’s talk. 🚀
