Sun protection claims are among the most strictly regulated in the cosmetics industry, and rightfully so. SPF and UVA protection ratings on labels are not mere marketing claims; they are guarantees of performance that consumers trust to shield their skin. Ensuring those numbers are accurate and validated through recognized testing methods is essential for both consumer safety and brand trust.

However, what qualifies as “correct” varies by market. As this article explains, different regions have their own definitions of sunscreen, acceptable testing methods, and labeling requirements. For companies aiming to launch products in multiple regions, understanding these variations early, rather than viewing efficacy testing as the final step, is the difference between smooth registration or months of delays.

What Do SPF and UVA Protection Mean, and Why Do They Matter?

The Sun Protection Factor (SPF) indicates how well a sunscreen protects against UVB rays, which have a medium-wavelength ultraviolet radiation (around 280-315 nanometers (nm)) and can penetrate the skin’s outer layer, the epidermis. However, SPF does not measure protection from UVA rays. UVA rays, have a longer wavelength (around 315- 380 nm) and can penetrate deeper into the skin.

We often hear that UVB causes burns and UVA causes ageing, because UVA penetrates deeper into the skin and leads to photoaging. However, this is a common misconception. Although UVA penetrates slightly deeper, some UVB also reaches these depths. UVB rays, being more energetic and reactive, can also lead to mutations in the skin’s outer layer and provoke sun damage. However, studies on humans and mice show that UVB also causes signs of ageing, like elastosis, which is a key feature of photoaging.

How Do We Define a Sunscreen Product and What Is It Supposed To Do?

Protecting skin from excessive exposure to UV radiation is extremely important, and using sunscreens plays a big part in this when combined with other measures: shade, clothing, UV avoidance during peak hours.

Under the 2006 EU Commission Recommendation (2006/647/EC), a sunscreen product is defined as “any preparation (such as creams, oils, gels, sprays) intended to be placed in contact with the human skin with a view exclusively or mainly to protecting it from UV radiation by absorbing, scattering or reflecting radiation.” Sunscreen products must provide for a minimum degree of protection against UVB and UVA radiation, measured using standardized, reproducible methods that take photodegradation into account.

What Should Industry Players Keep in Mind When Launching a Sunscreen?

For industry players, the sunscreen category can be quite challenging to expand globally. This is due to both regulatory requirements and the scientific proof they need to provide. Here are our top three suggestions that companies might find helpful as they begin their project: 

1. Verify permitted UV filters early. Before beginning the formulation phase, check the positive UV filter list in each target market and confirm the formulation contains no restricted or recently banned UV filters.  
2. Confirm the product's regulatory classification. Sunscreen products are not uniformly classified as cosmetics. In Europe, they are cosmetics with no pre-market approval required. In China, South Korea, Japan, and the United States, the classification of sunscreens differs. [See table below.]
3. Plan a market-specific claims substantiation testing process. This way, the sun protection claims, including SPF and UVA protection, are validated using the specific testing methods, panel setups, UV filters, and regulations relevant to each region. Relying on a one-size-fits-all global strategy that treats efficacy as just a checkbox almost always costs more time and money than a tailored approach.

How Does Sun Protection Testing Look in the EU, UK and Chinese markets?

EU

In the EU, SPF has traditionally been assessed in vivo under ISO 24444. UVA protection must hit at least a third of the labeled SPF. This means if the sunscreen features an SPF of 30, then the UVA protection factor (UVA-PF) must reach at least 10. UVA can be generally evaluated in vivo under ISO 24442 or in vitro under ISO 24443 methods, and the critical wavelength must be ≥  370nm for the “UVA in a circle” logo to be used.

The 2006 EU Commission Recommendation (2006/647/EC) offers helpful guidelines for labeling, including how to show measured SPF and categorize photoprotection from low to very high. To make it easier for consumers to compare products without limiting their options, the Recommendation suggested limiting the number of SPF values displayed on labels. Here’s a recommended range of SPF numbers for each category, along with the appropriate labeling.

Recently, two new ISO standards have been introduced, enabling in vitro and hybrid alternatives to reduce human-panel testing and the ethical concerns that come along with it:

• ISO 23675:2024 – Double Plate Method (DPM). A laboratory based in-vitro SPF test using UV-transparent polymer plates, which removes ethical concerns over human volunteers. This method consistently delivers reliable and reproducible results. Currently, it can be used for testing emulsions and single-phase alcoholic formulas, but is not yet suitable for sticks, powders, or water-resistant claims.
• ISO 23698:2024 – Hybrid Diffuse Reflectance Spectroscopy (HDRS). An innovative hybrid in vitro method that combines diffuse reflectance spectroscopy with a mathematical model. It can measure SPF, UVA protection factor, and critical wavelength protection without biological testing. It works well for emulsions and single-phase products but hasn't yet been tested with powder sunscreens. HDRS provides detailed spectral data to assist in estimating a sunscreen's effectiveness against sunburn and UVA rays.

While both these methods lessen the ethical concerns associated with human-volunteer UV testing and offer quicker alternatives for SPF measurement, they still face limitations. They are not yet universally accepted by all regulatory bodies worldwide; therefore, brands should expect to retain in vivo data for SPF as a fallback.

UK

After Brexit, the UK kept an approach to sun protection closely aligned with the EU on testing: the same ISO methods, including the one-third UVA rule and a 370nm critical wavelength threshold. The main difference lies in permitted UV filters, such as the ban on 4-MBC. Additionally, the UK employs the Boots Star Rating System for UVA protection, originally developed by The Boots Company, which has become a widely adopted standard grading method for products marketed in the UK.

China

A sunscreen that has been tested and notified in the EU or UK cannot simply be placed on the Chinese market. Sunscreens are classified as ‘special cosmetics’ and need full registration under China’s Cosmetic Supervision and Administration Regulation (CSAR), this usually takes about 10-12 months. Along with these regulatory differences, the sun protection efficacy must also be tested in an accredited Chinese laboratory using the country’s official testing procedures.

To register a sunscreen product with China's National Medical Product Administration (NMPA), you'll need to go through the Cosmetic Registration and Filing Inspection Management System. This involves submitting a request to an accredited laboratory, which must then officially accept the sample within that system. Only reports generated through this traceable process within the NMPA system are accepted for registration.

China primarily uses the Safety and Technical Standards for Cosmetics (STSC) approach for sun protection research. Although ISO methods are not officially recognized, they are still accepted, including ISO 24444 for SPF and ISO 24442 for UVA. An essential requirement is that microbiological, physicochemical, and toxicological tests must be conducted in an accredited lab first, followed by a human patch test. Only after successfully passing the patch test can sun protection efficacy tests begin.

Typically, companies need to open an account in the NMPA system and submit a request through that testing platform to get approval from a designated Chinese testing laboratory. This lab will then conduct safety studies, including microbiology, heavy metals, toxicology, and patch tests. Once these are successful, they can move forward with SPF and UVA efficacy testing.

Remember, both STSC and ISO methods are acceptable here. Just keep in mind, China does not accept in vitro UVA testing methods.

From a labeling perspective, China also regulates SPF and UVA labels. While there are no specific restrictions like in the EU, the minimum SPF label must be 2, and the maximum is 50+. For UVA protection, China employs the PA rating system, which indicates the ‘Protection Grade of UVA' with plus signs showing the level of UVA protection. Originally developed in Japan, this system is now widely used across Asia, and the labels follow this format:

The NMPA has been strengthening its guidelines lately, with new sunscreen-specific technical protocols from the National Institutes of Food and Drug Control (NIFDC), as well as updated safety testing requirements that became mandatory from July 2026.

Getting Sunscreen Compliance Right From the Start

Sun protection testing sits at the crossroads of science, regulation, and consumer trust. As the global demand for sunscreens grows, so does the scrutiny of the claims brands make. While the EU and UK have similar approaches, China’s classification of sunscreens as ‘special cosmetics’ introduces unique requirements around testing, registration, and labeling.

For companies in the industry, the main takeaway is to treat sun protection claims with the same care as the formulation itself. Confirm the permitted UV filters, product classification, and testing methods for each target market from the beginning, and they’ll avoid costly rework later on and save time.

If you're looking to launch or expand a sunscreen line in global markets, the CIRS Group’s regulatory and testing teams can help. We advise on regulatory compliance and conduct testing in the CIRS Testing Lab to meet each region’s requirements. You can reach us via service@cirs-group.com. 

Further information

• South Korea MFDS Proposes to Introduce In Vitro Test Methods for Sunscreen Cosmetics
• CIRS Sun Protection Testing Services