Many of our clients inquire about sunscreen formulations with SPF values exceeding 50, especially since some international brands promote products with ultra-high SPFs, and our clients aim to compete with them. However, as experts in Korean cosmetic manufacturing, we believe it’s essential to educate our clients on the technical complexities involved in creating such formulations. Sunscreens with ultra-high SPF values, like SPF 100 or even SPF 200, present unique scientific challenges. While these products claim to offer superior sun protection, their formulation is far from straightforward. In this article, we explore the key factors to consider when developing high-SPF sunscreens and what to keep in mind when aiming to bring such products to market.

In this article, we will discuss:

1. What is SPF?

2. Ingredient selection for SPF

3. SPF formulation challenges

1. What is SPF?

SPF, or Sun Protection Factor, is a measure of how well a sunscreen protects the skin from harmful ultraviolet B (UVB) rays, which are primarily responsible for sunburn and contribute to skin cancer. The SPF number indicates how much longer you can stay in the sun without getting burned compared to not using any sunscreen. For example, if you normally start to burn after 10 minutes in the sun, an SPF 30 sunscreen would theoretically allow you to stay in the sun 30 times longer, or 300 minutes, before burning. However, SPF does not measure protection against UVA rays, which can also cause skin aging and contribute to skin cancer, so it's important to choose broad-spectrum sunscreens that protect against both UVA and UVB rays for comprehensive sun protection.

Therefore, an SPF 100 sunscreen theoretically allows you to stay in the sun 100 times longer without burning than if you were unprotected. However, the difference in UVB protection between SPF 50 and SPF 100 is marginal— SPF 50 blocks about 98% of UVB rays, while SPF 100 blocks about 99% . This minimal difference means that higher SPF numbers may not offer significantly better protection in practical terms. Additionally, it’s important to remember that no sunscreen, regardless of its SPF, can provide 100% protection. Proper application, including reapplying every two hours and using other forms of sun protection like clothing and hats, is crucial for effective sun safety.

2. Ingredient selection for SPF

Formulating SPF 100 or SPF 200 sunscreens requires the careful selection and precise balance of active ingredients. Achieving such high SPF ratings requires a combination of chemical and physical UV filters that work together to provide enhanced coverage against harmful ultraviolet B (UVB) rays. These typically include a combination of chemical and physical filters:

• Chemical Filters like avobenzone, octocrylene, and homosalate absorb UV radiation and transform it into heat, which is then released from the skin.

• Physical Filters like zinc oxide and titanium dioxide act as physical barriers, reflecting and scattering UV rays away from the skin.

To achieve such high SPF levels, a greater concentration of these active ingredients is often necessary, which brings us to our next point.

3. SPF formulation challenges

Regardless of whether UV filters are physical or chemical, they must remain stable, not degrade over time, and not interact negatively with other ingredients. The formula must also be formulated to minimize irritation and sensitivity, and must be comfortable for application. After all, who wants to apply a product on their skin if it irritates their skin, or if it leaves a white cast or greasy residue, right? Unfortunately, creating an ultra-high SPF sunscreen presents several formulation challenges:

• Texture and Feel: High levels of active ingredients can make the sunscreen thicker, greasier, or leave a white cast on the skin. Formulators need to work carefully to create a product that feels pleasant to use while maintaining high efficacy.

• Stability: Sunscreens with higher SPF are more prone to instability, meaning the active ingredients can degrade more quickly when exposed to light or heat. Ensuring the stability of these formulas is crucial to maintaining their effectiveness.

• Spreadability: To achieve the advertised SPF level, the sunscreen must be applied evenly and in sufficient quantity. However, thicker formulations can be harder to spread, which may lead to uneven application and reduced protection.

Formulators may use additional ingredients to ensure stability, spreadability, and comfort in high-SPF sunscreens. These ingredients, often referred to as "filler" or "functional" ingredients, help maintain the product's feel and performance. Common examples include emollients, thickeners, stabilizers, and emulsifiers, which contribute to the overall texture, prevent separation, and enhance the product's application. They are also critical in helping active UV filters remain stable and effective throughout the product’s lifespan.

When it comes to safety, these filler ingredients are generally safe at the concentrations used in cosmetic formulations. Cosmetic chemists carefully select these ingredients and test them in the context of the full formula to ensure they are non-irritating and suitable for skin application, even in higher concentrations. Regulatory bodies, like the FDA and the European Commission, provide guidelines for the safe usage levels of these substances.

However, each ingredient must be assessed on an individual basis to ensure it’s suitable for the target market (in compliance with the local cosmetic/drug regulations) and skin type. For ultra-high SPF sunscreens, the selection and balance of these filler ingredients are particularly critical, as they can affect the final product’s aesthetics, stability, and, ultimately, its consumer appeal.

4. Regulatory considerations and consumer (mis)perception

In South Korea, as in many other countries, sunscreen regulation is governed by strict guidelines to ensure consumer safety and product efficacy. The maximum SPF rating allowed on sunscreen labels by Korean regulators, specifically the Ministry of Food and Drug Safety (MFDS), is generally SPF 50+. While products with SPF ratings higher than 50 can exist, they are usually labeled as "SPF 50+" rather than specifying an exact number like SPF 100 or SPF 200.

For products claiming SPF ratings above 50, like SPF 100 or SPF 200, the MFDS would require extensive clinical and non-clinical testing data to substantiate these claims. This includes in vivo (on human subjects) and in vitro (lab-based) testing to demonstrate that the product indeed offers higher protection and is safe for regular use. However, such claims might face skepticism from the regulators for several reasons:

• Diminishing Returns on Protection: The increase in UVB protection between SPF 50 and SPF 100 is marginal. For instance, while SPF 50 blocks about 98% of UVB rays, SPF 100 blocks approximately 99%, a mere 1% increase in protection. Korean regulators, like many others, recognize this diminishing return and question the necessity of labeling a product with such high SPF numbers.

• Safety Concerns: Higher SPF formulations often require increased concentrations of active ingredients, such as chemical filters. The MFDS may have concerns about the potential for skin irritation, allergic reactions, or other adverse effects, especially with prolonged use or in sensitive populations. These safety concerns are paramount, and the burden of proof lies heavily on the manufacturer.

• Consumer Misunderstanding: While SPF 100 or 200 might appeal to consumers seeking maximum protection, it is crucial to educate them on the limitations of sunscreen. There is a concern that higher SPF numbers could lead to a false sense of security, causing consumers to spend more time in the sun without reapplying sunscreen as needed. It’s important to communicate that no sunscreen, regardless of its SPF, can provide 100% protection from UV rays. The MFDS emphasizes the importance of proper sun protection behavior, such as reapplying sunscreen every two hours and wearing protective clothing, rather than relying solely on a very high SPF rating.

Due to these factors, Korean regulators generally discourage the marketing of sunscreens with excessively high SPF numbers like SPF 100 or SPF 200. Instead, products are typically labeled with "SPF 50+" as the highest standard, which communicates that the sunscreen provides strong protection without overstating its efficacy.

The stance of the MFDS aligns with that of many international regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Commission, which also cap SPF labeling at 50+ or 60+ to prevent misleading claims. These regulatory approaches aim to balance consumer protection with practical and scientifically-supported sun safety recommendations.

6. Balancing UVA and UVB protection in a formula

High SPF ratings are commonly associated with a sunscreen's ability to protect against UVB rays, which are the primary cause of sunburn and are linked to the development of skin cancer. However, SPF does not measure protection against UVA rays, which penetrate deeper into the skin and are primarily responsible for skin aging, wrinkles, and long-term damage like photoaging.

In several Asian countries, including South Korea and Japan, UVA protection is often indicated by a "PA" rating, which stands for "Protection Grade of UVA." The PA rating is followed by plus signs, such as PA+, PA++, PA+++, or PA++++. The more plus signs, the higher the UVA protection:

• PA+: Some UVA protection

• PA++: Moderate UVA protection

• PA+++: High UVA protection

• PA++++: Extremely high UVA protection

To ensure comprehensive protection, sunscreens need to offer broad-spectrum coverage, which means they protect against both UVB and UVA rays. Achieving this balanced protection is complex because UVA and UVB rays differ in wavelength and penetration depth, requiring different types of filters. UVB rays, which have shorter wavelengths, are generally easier to block. Meanwhile, UVA rays, with longer wavelengths, penetrate more deeply and require ingredients specifically designed to absorb or reflect them effectively.

The formulation process for broad-spectrum sunscreens involves selecting a combination of chemical and physical filters that can cover this full spectrum. Many high-SPF products focus on boosting UVB protection with ingredients like oxybenzone or octinoxate, which can absorb UVB rays well. However, ensuring sufficient UVA protection requires additional ingredients, such as zinc oxide, titanium dioxide, or avobenzone.

Moreover, maintaining both high SPF and strong UVA protection in a single product can pose challenges in formulation stability, texture, and user experience. For instance, certain UVA filters may degrade more quickly under sunlight, reducing their effectiveness unless stabilized. Additionally, achieving high levels of both types of protection can result in thicker, less pleasant textures, which can discourage regular use. Therefore, manufacturers often need to carefully balance the types and amounts of filters used to ensure both safety and consumer appeal, as well as adequate protection across the UV spectrum.

7. Environmental Impact

Another crucial consideration in formulating high-SPF sunscreens is their environmental impact. Many chemical UV filters, such as oxybenzone and octinoxate, have been identified as harmful to marine ecosystems, particularly coral reefs. These ingredients can contribute to coral bleaching and disrupt marine life, prompting increased scrutiny and regulation.

As consumer awareness and demand for eco-friendly and reef-safe products rise, formulators face the challenge of achieving high SPF ratings while minimizing environmental harm. This necessitates the development of alternative UV filters and formulation strategies that are both effective in sun protection and safe for aquatic environments. However, developing marine-safe sunscreen ingredients is a complex and lengthy process. Alternatives to common UV filters, like oxybenzone and octinoxate, are needed due to their harmful effects on coral reefs and marine life, such as causing coral bleaching and DNA damage in corals. However, finding viable replacements that provide comparable SPF protection without harming aquatic ecosystems is challenging.

The development of these eco-friendly ingredients involves rigorous research, testing, and regulatory approval, which can span years. Effective alternatives must be not only safe for the environment but also stable, non-toxic to humans, and compatible with other sunscreen components to ensure broad-spectrum protection. Mineral UV filters like non-nano zinc oxide and titanium dioxide are often considered safer for marine life, but even these have limitations and can be costly and technically challenging to formulate at high SPFs​.

Because of these complexities, we may not see widespread availability of truly reef-safe, high-SPF sunscreens in the immediate future. Ongoing research and innovation are essential to balancing effective sun protection with environmental safety, but for now, progress remains gradual as scientists explore and refine alternatives.

Ready to develop your next sunscreen innovation?

At MAYK, we specialize in partnering with leading Korean cosmetic manufacturers to bring your skincare formulations to life. If you're interested in creating your sunscreen product, our expert team can guide you through the complexities of product development, ensuring high quality and regulatory compliance.

Contact us today to start your journey towards creating sunscreen products. Let's work together to achieve your vision and meet the growing demands of the beauty industry.

Reach out to MAYK now.