As a leading cosmetics manufacturing partner in the UK and US, our mission at THG  LABS extends beyond formulation and production; we also offer our customers knowledge and support by guiding them through the intricate processes associated with their beauty brand’s sunscreen compliance.

In this blog post, our Quality Director, Richard Keightley, explores the many considerations involved in global sunscreen compliance and how our expertise and commitment to excellence makes THG LABS the perfect partner for product development and manufacturing your suncare range.    

Understanding the Spectrum of Sunscreen Regulations

Sunscreen products are regulated differently around the world, classified variably as cosmetics, over-the-counter (OTC) drugs, or even therapeutic goods, depending on the jurisdiction.

This classification impacts the regulatory pathway a product must follow. For instance, in the United States, sunscreens are considered OTC drugs as well as Cosmetics and are regulated by the FDA, with specific testing, manufacturing requirements, efficacy claims and labelling prescribed in a Monograph.

In contrast, the European Union categorises sunscreens only as cosmetic products.  EU and UK Cosmetics Regulations demanding a high level of safety and efficacy evidence, currently labelling requirements are outlined through a Recommendation.

Key Requirements for Global Compliance

Ingredient Approval:
The list of UV filters that are approved for use varies significantly by region. For example, the U.S. FDA has approved only a limited number of UV filters compared to the broader list recognised in the EU and Asia-Pacific regions. Keeping up-to-speed with these differences, as well as horizon scanning for further updates, is crucial for formulating products that are compliant in your target markets. 

SPF and UVA Protection Standards:
The method for measuring SPF (Sun Protection Factor) is relatively harmonised globally; however, there are differences in UVA protection standards and testing methods. The EU requires a UVA protection factor that is at least a third of the labelled SPF, denoted by the UVA logo. Understanding and integrating these requirements into product development is essential. 

Labelling and Claims:
Regulatory bodies also differ in their requirements for product labelling and claims. The language, symbols, and claims allowed on sunscreen packaging can significantly impact your product's marketability and legal compliance. For example, terms like "broad spectrum" and "water-resistant" have specific definitions and testing requirements. 

Safety and Efficacy Documentation:
Robust documentation demonstrating the safety and efficacy of your sunscreen product is a cornerstone of compliance. This includes detailed records of formulations, ingredient sourcing, manufacturing processes, and product testing results.

Leveraging Expertise for Compliance and Innovation

Navigating the complexity of global regulations requires a partner with deep expertise and a proactive, robust approach to regulatory compliance. Here’s how we support our brand partners:

Regulatory Intelligence:
Our specialist team continuously monitors the dynamic regulatory landscape, ensuring that your products meet the latest standards across your target markets.

Custom Formulation:
Leveraging a global palette of approved UV filters and innovative formulation technologies, we develop sun care products that not only comply with global regulations but also meet the high expectations of consumers – both in terms of efficacy and sensorial performance.

Comprehensive Testing and Documentation:
From SPF and UVA protection tests to safety assessments and stability studies, THG LABS team manage the entire testing process, providing the necessary documentation to support product registrations worldwide.

Strategic Labelling and Marketing Support:
Understanding the regulatory nuances of product claims and labelling, we guide our partners in crafting compliant and compelling packaging and marketing materials.

Explore how THG LABS can help your brand

At the core of successful sun care product launches is a nuanced understanding of global sunscreen compliance. As your cosmetics manufacturing partner, THG LABS goal is to demystify these complexities, enabling you to navigate the global marketplace with confidence and innovation.

For brands looking to make their mark in the sun care sector, partnering with a knowledgeable and experienced manufacturer is not just an option; it's a necessity. If you’re keen to find out more about our approach and how our full-service model flexes to support with solutions where your brand needs them, please get in touch www.thglabs.com/contact

ABOUT THE AUTHOR

Richard Keightley
Regulatory and Quality Director, THG LABS

Richard Keightley  first joined THG LABS as a development chemist more than twenty years ago. Fast forward several decades and many roles later which have seen him working in all areas of the business from NPD through to scale up and manufacturing, he is now THG LABS Regulatory and Quality Director with a remit which includes both our UK and US facilities.

Richard’s role encompasses all areas of compliance including; Global Cosmetic Regs and OTC requirements, claims substantiation, advertising media, product safety, REACh and other chemical legislation.  It also incorporates supplier approval and monitoring ensuring that suppliers working with THG LABS meet our strict ethical and quality requirements.  Providing advice to our beauty customers and suppliers, Richard and his team at work closely with our in-house experts in Marketing, R&D, Production and Supply.  His broad experience in the world of beauty gives him an excellent insight into requirements and aspirations within the cosmetics industry value chain, enabling him to influence sustainable practices throughout the lifecycle of products we produce for world-leading global brands.

Richard Chairs the CTPA Sustainability Committee and contributes regularly to their Cosmetovigilance and REACh Advisory Groups.  He also represents THG LABS on the PCPC International Committee and is a member of the Society of Cosmetic Scientists.