SPF Sunscreens and Cosmetic Regulation
Awareness about the risks of sun exposure is increasing, leading to a significant change in skin protection habits. Now, more than ever, the population opts for sunscreens with a high sun protection factor (SPF) not only during the summer but throughout the year.
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Mandatory Tests for Sunscreens
Cosmetic Regulation
To comply with European recommendations, sunscreens must undergo specific tests to evaluate their degree of protection against UVA and UVB rays. These include:
• In vivo SPF test according to ISO 24444
• UVA protection factor in vivo or in vitro according to ISO 24443 , in addition to the critical wavelength
• Sunscreens should have an SPF of at least 6, UVA protection of at least 1/3 of the labeled SPF, and a critical wavelength greater than 370nm.
SPF+ Sunscreens
Sun protection factor, or SPF, is a critical indicator of the level of protection a sunscreen product offers against the sun's harmful UVB rays. UVB rays are primarily responsible for sunburn and can significantly contribute to the risk of skin cancer.
As awareness of skin health increases, products with high SPF, known as SPF+, are gaining popularity. Here we explore what "SPF+" really means, how it works, and why it's important to consider products with high protection.
What does SPF+ mean?
The term "SPF+" generally refers to sunscreens with a sun protection factor of 50 or higher. These products are designed to offer superior protection against UVB rays, providing users with a more robust defense against sunburn and, by extension, against the risk of developing skin cancer.
How SPF Works
SPF measures a sunscreen's ability to block UVB rays. For example, an SPF of 30 means you can theoretically stay in the sun 30 times longer than you could without protection before getting burned. However, this calculation is more theoretical than practical, since the effectiveness of sunscreen can be affected by several factors, such as improper application, sweat, and water.
The Importance of SPF+ Sunscreens
Products with SPF+ are particularly beneficial for:
• Light-skinned people: Those with light skin are more susceptible to sunburn and long-term sun damage.
• Prolonged sun exposure: If you plan to be outdoors for long periods, especially during peak UV radiation hours (between 10 a.m. and 4 p.m.), an SPF+ may offer longer-lasting protection.
• High altitude areas and reflective surfaces: In high altitude locations or near surfaces that reflect sunlight, such as sand, water and snow, UV rays can be particularly intense
Recommendations for the Application of SPF+
• Apply generously: Dermatologists recommend using about one ounce (which fits in a shot glass) to cover all exposed areas of the body and reapply every two hours or after swimming or sweating.
• Don't forget commonly overlooked areas: These include the ears, neck, feet, and the edges of swimwear.
• Use daily: Even on cloudy days, up to 80% of UV rays can penetrate the skin. Incorporating a sunscreen with SPF+ into your daily routine can offer continued protection.
SPF+ and the Environment
When choosing a sunscreen with SPF+, it is also essential to consider its environmental impact. Some ingredients in sunscreens can be harmful to marine ecosystems, including coral reefs. Opting for “Reef-Friendly” sunscreens, which avoid harmful ingredients like oxybenzone and octinoxate, can help protect these vulnerable ecosystems.
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Choosing a sunscreen with SPF+ is a crucial step towards effective sun protection. Not only does it help prevent sunburn, it also reduces the risk of long-term sun damage, including skin cancer. By following application recommendations and choosing environmentally friendly products, you can enjoy the sun safely and responsibly.
SPF, Regulatory Framework
Sunscreen regulation in Europe and the United Kingdom encompasses a set of regulations and guidelines designed to ensure the safety and effectiveness of these products essential for protection against harmful ultraviolet (UV) rays.
Although the United Kingdom and the European Union shared a common regulatory framework until the end of the Brexit transition period in December 2020, there are continuing similarities in their regulatory approaches, as well as specific differences worth highlighting.
SPF: European Union
EC 1223/2009
In the European Union, sunscreens are classified as cosmetics and are regulated under the Cosmetic Products Regulation (Regulation (EC) No 1223/2009). This regulation establishes strict rules to ensure the safety and effectiveness of cosmetics marketed in the EU.
Key Aspects of Regulation in the EU
• Safety Evaluation: All cosmetic products, including sunscreens, must have a safety evaluation before being placed on the market.
• Notification: Manufacturers must notify the European Commission of any cosmetic product placed on the market through the Cosmetic Product Notification Portal (CPNP).
• Labeling: The information provided on the label must be clear and include instructions for use, SPF protection level, and whether the product offers UVA protection.
• Claims: Claims made on cosmetic products, including sunscreens, must be verifiable and not misleading.
SPF: UK
Following Brexit, the UK has adopted the EU Cosmetics Regulation framework into its legislation, with some adaptations to reflect that it is no longer an EU member state. Regulation in the UK is administered by the Medicines and Healthcare products Regulation Office (MHRA) and remains largely parallel to that in the EU.
Key differences since Brexit
• Notification Portal: Manufacturers must use the UK portal to notify cosmetic products, separate from the EU portal.
• Responsible Representative: For imported products, a responsible representative established in the United Kingdom is required.
Similarities with the EU
• Safety Assessment, Labeling and Claims: Requirements for safety assessment, labeling and claims of sunscreens remain consistent with EU standards, ensuring a high level of protection for consumers.
Implications for Manufacturers and Consumers
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For manufacturers, regulatory consistency between the EU and the UK makes it easier to market sunscreens in both markets, although specific differences need to be taken into account, especially in terms of notification and legal representation.
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For consumers, these regulations ensure that sunscreens available on the market are safe and effective, offering reliable protection against the harmful effects of sun exposure. It is crucial that consumers follow the instructions for use provided on the labeling to maximize the effectiveness of the product.
In both the European Union and the United Kingdom, sunscreen regulation focuses on ensuring the safety and effectiveness of these essential products. Although there are specific differences in post-Brexit regulatory implementation, the shared commitment to consumer protection continues to be a fundamental pillar in both territories.
SPF: United States
FDA regulations
The regulation of sunscreens in the United States, especially those categorized as over-the-counter (OTC) medications, is an area of rigorous oversight conducted by the Food and Drug Administration (FDA).
The classification of sunscreens as OTC is due to their essential role in preventing sunburn and potentially reducing the risk of skin cancer and premature aging caused by exposure to ultraviolet (UV) rays.
Sunscreen Monograph
A key component of the regulation is the "Sunscreen Monograph," a document that establishes conditions under which sunscreens can be considered safe and effective, and therefore, marketed without the need for individual prior approval by the FDA. .
The monograph details aspects such as:
Allowed active ingredients and their concentrations.
Test methods to determine Sun Protection Factor (SPF) and broad spectrum protection.
Labeling requirements, including instructions for use and warnings.
Labeling and Claims
SPF (Sun Protection Factor): It must indicate the level of protection against UVB rays.
Broad Spectrum Protection: Indicates whether the product offers balanced protection against both UVA (which can contribute to skin cancer and premature aging) and UVB.
Water Resistance: If a product claims to be water resistant, it must specify how long it remains effective when swimming or sweating, based on standard tests.
Active ingredients
The sunscreen monograph identifies active ingredients that have been recognized as safe and effective for use in sunscreens. Any new ingredient that is intended to be used requires the submission of a New Drug Application (NDA) for evaluation and approval by the FDA.
Challenges and Regulatory Updates
The science and technology behind sunscreens are constantly evolving, leading the FDA to periodically review and update its regulations. This includes re-evaluating the safety of active ingredients and considering approval of new ingredients that may offer additional or improved benefits.
Implications for Consumers
Consumers should be aware of the importance of using sunscreens that meet FDA regulations to ensure effective protection against sun damage. It is essential to read and follow labeling instructions, paying particular attention to SPF, broad-spectrum protection, and water resistance claims.