What is a Secondary Sunscreen Product? Definition and Examples
The European Commission defines a sunscreen product as any preparation (such as creams, oils, gels, aerosols, etc.) intended to protect the skin from UV radiation by absorbing, dispersing, or reflecting it. Its primary function is to protect the skin from UV rays.
A secondary sunscreen product is a cosmetic that highlights SPF, but whose primary function is different. These products include foundations, day creams, or lip balms that offer sun protection often mentioned on the packaging through the SPF rating, besides their primary functions of makeup, hydration, or nourishment.
Primary and Secondary Sunscreens in Europe: Regulations and Requirements
The EU Cosmetic Product Regulation 1223/2009 incorporates a predefined positive list in its annexes for authorized UV filter ingredients in cosmetic products.
Moreover, the European Commission published the recommendation 2006/647/EC to guide on the efficacy of sunscreen products and the claims made relating when placing primary sunscreen products on the market. It entails specific conditions to respect to claim the sun protection effects and recommends specific precautions and warnings.
Primary sunscreens are specifically designed to provide UV protection as their main function in Europe. Their UV protection efficacy in protecting the skin against sunburn and minimizing the risk of long-term skin damage must be substantiated by standardized tests and certain conditions. Most of time, the substantiation of sun protection efficacy is made by the tests following ISO24444 and ISO24443 standards, which covers UVB and UVA testing standards. Other ISO standards cover water resistance testing and photostability testing, including standards related to labeling and claims for the finished product.
In contrast, secondary sunscreens serve multiple purposes. Their primary function may be to moisturize, beautify, or provide other benefits, with SPF protection as an additional feature. For example, a foundation with SPF 50, while offering significant SPF protection, is not challenged as strictly as primary sunscreens, which means the UVA tests and critical wavelength assessment are not mandatory for this product. Furthermore, the labeling for such products does not need to include the protection category (for example, high protection, very high protection, etc.) or extensive sun safety warnings that are mentioned in EC recommendation. However, the SPF claim must be substantiated through appropriate testing: secondary sunscreens are cosmetic products and must follow cosmetic regulation and the principle of evidential support: Claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence regardless of the types of evidential support used to substantiate them, including where appropriate expert assessments.
This distinction highlights that while sun protection in secondary sunscreens is an important feature, it is evaluated more as an added benefit rather than the primary function of the product.
Regulations for Secondary Sunscreens in North America: Everything You Need to Know
In North America sunscreen products are not regulated under the cosmetic regulations. The classification of a cosmetic product is based on 3 main criteria: claims, consumer perception and well-known therapeutic use. In the case of sunscreen products, the presence of active ingredient requires a specific classification of the product under the drug regulation as an OTC product in the US, and either the NHP or NPD regulation in Canada.
United States
The Food and Drug Administration (FDA) classifies all sunscreens, whether primary or secondary, as over-the-counter (OTC) drugs. This classification necessitates adherence to specific formulation, testing, and labeling guidelines as outlined in the FDA's OTC monograph for sunscreens. The monograph specifies the allowable types of UV filters, their maximum concentrations, and the required tests for both UVA and UVB protection. Comprehensive labeling requirements include directions for use, warnings (such as advising users to consult a doctor before use on children under six months of age), and accurate SPF values based on standardized testing procedures.
The FDA mandates that secondary sunscreen products meet the same rigorous standards (same monograph, same registration) as primary sunscreens, ensuring that any cosmetic product with an SPF claim provides a reliable level of UV protection.
Canada
The regulation of sunscreens, including secondary sunscreens, is similarly stringent but follows a different framework. Health Canada classifies sunscreens as either non-prescription drugs (NPD) or natural health products (NHP), depending on the nature of the active ingredients and their intended uses. The classification impacts the testing and labeling requirements.
For secondary sunscreens, Health Canada provides specific guidelines through a dedicated monograph for secondary sunscreens. This monograph details acceptable ingredients, labeling requirements, and permitted health claims. Unlike the U.S., where the focus is heavily on the chemical composition and efficacy, Canadian regulations also emphasize the accurate representation of the sunscreen's benefits and limitations on the packaging to prevent consumer misunderstanding.
Furthermore, products classified under Natural Health Products must also comply with the Natural Health Products Regulations, which require manufacturers to obtain a product license before selling. The licensing process involves submitting detailed information on the product's ingredients, source, dose, potency, and recommended use. On another hand, Non-Prescription Drug products have their own separate regulatory requirements (labeling, registration etc.) and are subject to approval by Health Canada, to obtain a Drug Identification Number.
The Case of South Korea
South Korea is highly innovative in sun product development, especially for secondary sun products.
Secondary sunscreens are regulated under the cosmetic regulations but with stringent requirements concerning SPF labeling and efficacy. The Korean Food and Drug Administration (KFDA) requires that all products claiming UV protection, whether primary or secondary, undergo similar efficacy testing. This approach ensures that any product with an SPF label, regardless of its primary function, meets minimum safety and effectiveness standards. This regulatory stance emphasizes consumer safety and product reliability, bridging the gap somewhat between the more segmented approaches seen in the US and Canada and the more generalized European framework.
While secondary sunscreen products are increasingly common in the market, the distinction between regulatory approaches in Europe, North America, and Asia, particularly South Korea, emphasizes the need for global companies to navigate varying local regulations carefully.
Europe's more conservative stance on UV filter authorization and the lack of specific regulations for secondary sunscreens contrast with the detailed frameworks in the US, Canada, and South Korea, where the delineation between product categories is clearer and more regulated. This divergence necessitates a strategic approach in product development and marketing to ensure compliance and consumer safety across different markets.
_
Need help?
Contact our experts now, they'll be happy to help you!
What is a Secondary Sunscreen Product? Definition and Examples
The European Commission defines a sunscreen product as any preparation (such as creams, oils, gels, aerosols, etc.) intended to protect the skin from UV radiation by absorbing, dispersing, or reflecting it. Its primary function is to protect the skin from UV rays.
A secondary sunscreen product is a cosmetic that highlights SPF, but whose primary function is different. These products include foundations, day creams, or lip balms that offer sun protection often mentioned on the packaging through the SPF rating, besides their primary functions of makeup, hydration, or nourishment.
Primary and Secondary Sunscreens in Europe: Regulations and Requirements
The EU Cosmetic Product Regulation 1223/2009 incorporates a predefined positive list in its annexes for authorized UV filter ingredients in cosmetic products.
Moreover, the European Commission published the recommendation 2006/647/EC to guide on the efficacy of sunscreen products and the claims made relating when placing primary sunscreen products on the market. It entails specific conditions to respect to claim the sun protection effects and recommends specific precautions and warnings.
Primary sunscreens are specifically designed to provide UV protection as their main function in Europe. Their UV protection efficacy in protecting the skin against sunburn and minimizing the risk of long-term skin damage must be substantiated by standardized tests and certain conditions. Most of time, the substantiation of sun protection efficacy is made by the tests following ISO24444 and ISO24443 standards, which covers UVB and UVA testing standards. Other ISO standards cover water resistance testing and photostability testing, including standards related to labeling and claims for the finished product.
In contrast, secondary sunscreens serve multiple purposes. Their primary function may be to moisturize, beautify, or provide other benefits, with SPF protection as an additional feature. For example, a foundation with SPF 50, while offering significant SPF protection, is not challenged as strictly as primary sunscreens, which means the UVA tests and critical wavelength assessment are not mandatory for this product. Furthermore, the labeling for such products does not need to include the protection category (for example, high protection, very high protection, etc.) or extensive sun safety warnings that are mentioned in EC recommendation. However, the SPF claim must be substantiated through appropriate testing: secondary sunscreens are cosmetic products and must follow cosmetic regulation and the principle of evidential support: Claims for cosmetic products, whether explicit or implicit, shall be supported by adequate and verifiable evidence regardless of the types of evidential support used to substantiate them, including where appropriate expert assessments.
This distinction highlights that while sun protection in secondary sunscreens is an important feature, it is evaluated more as an added benefit rather than the primary function of the product.
Regulations for Secondary Sunscreens in North America: Everything You Need to Know
In North America sunscreen products are not regulated under the cosmetic regulations. The classification of a cosmetic product is based on 3 main criteria: claims, consumer perception and well-known therapeutic use. In the case of sunscreen products, the presence of active ingredient requires a specific classification of the product under the drug regulation as an OTC product in the US, and either the NHP or NPD regulation in Canada.
United States
The Food and Drug Administration (FDA) classifies all sunscreens, whether primary or secondary, as over-the-counter (OTC) drugs. This classification necessitates adherence to specific formulation, testing, and labeling guidelines as outlined in the FDA's OTC monograph for sunscreens. The monograph specifies the allowable types of UV filters, their maximum concentrations, and the required tests for both UVA and UVB protection. Comprehensive labeling requirements include directions for use, warnings (such as advising users to consult a doctor before use on children under six months of age), and accurate SPF values based on standardized testing procedures.
The FDA mandates that secondary sunscreen products meet the same rigorous standards (same monograph, same registration) as primary sunscreens, ensuring that any cosmetic product with an SPF claim provides a reliable level of UV protection.
Canada
The regulation of sunscreens, including secondary sunscreens, is similarly stringent but follows a different framework. Health Canada classifies sunscreens as either non-prescription drugs (NPD) or natural health products (NHP), depending on the nature of the active ingredients and their intended uses. The classification impacts the testing and labeling requirements.
For secondary sunscreens, Health Canada provides specific guidelines through a dedicated monograph for secondary sunscreens. This monograph details acceptable ingredients, labeling requirements, and permitted health claims. Unlike the U.S., where the focus is heavily on the chemical composition and efficacy, Canadian regulations also emphasize the accurate representation of the sunscreen's benefits and limitations on the packaging to prevent consumer misunderstanding.
Furthermore, products classified under Natural Health Products must also comply with the Natural Health Products Regulations, which require manufacturers to obtain a product license before selling. The licensing process involves submitting detailed information on the product's ingredients, source, dose, potency, and recommended use. On another hand, Non-Prescription Drug products have their own separate regulatory requirements (labeling, registration etc.) and are subject to approval by Health Canada, to obtain a Drug Identification Number.
The Case of South Korea
South Korea is highly innovative in sun product development, especially for secondary sun products.
Secondary sunscreens are regulated under the cosmetic regulations but with stringent requirements concerning SPF labeling and efficacy. The Korean Food and Drug Administration (KFDA) requires that all products claiming UV protection, whether primary or secondary, undergo similar efficacy testing. This approach ensures that any product with an SPF label, regardless of its primary function, meets minimum safety and effectiveness standards. This regulatory stance emphasizes consumer safety and product reliability, bridging the gap somewhat between the more segmented approaches seen in the US and Canada and the more generalized European framework.
While secondary sunscreen products are increasingly common in the market, the distinction between regulatory approaches in Europe, North America, and Asia, particularly South Korea, emphasizes the need for global companies to navigate varying local regulations carefully.
Europe's more conservative stance on UV filter authorization and the lack of specific regulations for secondary sunscreens contrast with the detailed frameworks in the US, Canada, and South Korea, where the delineation between product categories is clearer and more regulated. This divergence necessitates a strategic approach in product development and marketing to ensure compliance and consumer safety across different markets.
_
Need help?
Contact our experts now, they'll be happy to help you!
