Sun Protection Products: Cosmetics Like Any Other from a Regulatory Perspective?
Formulating a sun protection product may seem simple on paper: some UV filters, a cosmetic base, and you’re done. In reality, it is far more complex. Not only from a strict formulation perspective, but also because the regulatory requirements for sunscreen make it a product apart.
Summer shelf superstars, sunscreens are often a challenge for formulators. Performance and sensoriality are even more essential for these products than for other cosmetics. But can we really speak of a cosmetic product when it helps to prevent skin cancers as much as sunburn or premature skin aging? Let’s zoom in on the regulatory framework for sun protection products.
In Europe: a cosmetic product with certain specificities
Under European cosmetics regulation, sunscreens fall under the same category as cosmetics, with no special status. We distinguish primary sun products, whose main function is UV protection, from secondary sun products, such as skin care or makeup claiming an SPF. This cosmetic status prohibits claims such as the prevention of actinic keratoses or skin cancers otherwise the product may fall under the scope of medical devices.
Despite their cosmetic status, sunscreens are subject to specific requirements. Their active ingredients — UV filters — are listed in Annex VI of Regulation (EC) No 1223/2009. Only these ingredients may be used as UV filters, and only within the listed restrictions. Consequently, for regulatory authorities, any product claiming sun protection must contain one or more Annex VI-listed UV filters. The approval and registration process for a new UV filter is long and complex, typically between 2 and 5 years.
In 2006, the European Commission issued a recommendation to industry regarding sunscreens and efficacy claims. While not legally binding, it remains the reference framework for primary sunscreens in Europe (including for market surveillance authorities). It harmonizes labelling, imposes safety warnings, and prohibits the use of the term “total screen”. Secondary, sun protection products are not yet concerned.
This 2006 recommendation is currently under revision, with first updates expected around late 2025 or early 2026. Among the topics under discussion: inclusion of secondary sun protection products, and the likely binding character of the upcoming text.
Aside from this recommendation, which governs claims, labelling, and efficacy testing, sunscreens remain cosmetics in Europe, offering flexibility in formats and galenic forms. Outside Europe, things get more complicated.
Internationally: cosmetics or not? Not so simple!
In some countries, sunscreens are considered “simple” cosmetic products, as in Europe. This is the case in Japan, Russia, or Saudi Arabia. There is no pre-market efficacy control, but post-market surveillance may occur.
In other countries, sunscreens retain cosmetic status but require specific registration. The submitted dossier must include proof of product efficacy. This is the case in Brazil, China, and South Korea. Only once registration is validated can the product be marketed.
In Canada, Australia (under certain criteria), and the United States, primary sunscreens are considered non-prescription medicines. In the US, they fall under OTC (Over-the-Counter) status, governed by the monograph system. This regulates the choice of approved UV filters, their concentration ranges, and mandatory labelling requirements. The OTC system is a real constraint in formulation, labelling, and galenic forms. In 2025, the FDA even notified brands selling in the US that mousse formulations were not validated under the OTC monograph.
* The choice of filters is restricted (mineral filters and older-generation organic filters), as the FDA has not approved a new UV filter for cosmetic use in more than 20 years.
Efficacy testing under strict frameworks
In Europe and globally, sunscreen efficacy tests must follow recognized, validated methods. Given reproducibility and reliability challenges, it is critical to adhere to internationally validated protocols. This is why several ISO standards exist for sunscreen testing, such as:
- ISO 24444: In vivo determination of SPF (UVB protection)
- ISO 24443: In vitro determination of UVA protection factor and critical wavelength
- ISO 24442: In vivo determination of UVA protection factor
- ISO 16217 and ISO 18861: Water resistance protocol and assessment
Two new ISO standards were published in 2025:
- ISO 23698 (HDRS): Hybrid in vitro/in vivo method for SPF and UVA PF determination
- ISO 23675 (double-plate method): In vitro SPF measurement
Other methods exist, but as they are non-standardized, they may not be recognized by authorities.
Depending on the country, accepted methods vary. In the US, the FDA method described in the sunscreen monograph is required for SPF determination (close to ISO 24444). In Europe, the 2006 recommendation provides guidelines, favoring an in vivo SPF method (ISO 24444), while preferring in vitro for UVA PF (ISO 24443) for ethical reasons — though all ISO methods are accepted.
Requirements on efficacy tests and labelling also vary. In Europe, UVB (SPF), UVA protection, and critical wavelength must be determined. Only SPF must appear on the label, but UVA protection must reach at least 1/3 of the claimed SPF (signaled by the UVA circle logo). In the US and Canada, UVB SPF and critical wavelength are required, enabling the “broad spectrum” claim. In Asia, UVA protection is indicated using the PA system (ISO 24442), marked by one to four “+”.
Conclusion
Sunscreens are definitely not cosmetics like any other. At the crossroads between aesthetics and public health, they demand strong formulation expertise to deliver performance. But above all, they are subject to numerous regulatory requirements even in regions where they retain cosmetic status. Complex to formulate for both performance and efficacy, they are even more challenging when aiming for international marketing. In this case, regulatory support is indispensable if not available in-house.
