The development of safe and effective sunscreens requires a deep understanding of regulatory frameworks governing UV active ingredients. These regulations vary by region, dictating permissible usage levels and specific requirements. NINGBO INNO PHARMCHEM CO.,LTD. provides an overview of the regulatory landscape for UV absorbers, focusing on 2-Phenylbenzimidazole-5-Sulfonic Acid (Ensulizole) and its global acceptance.

Global Regulatory Approvals for UV Filters

Sunscreen ingredients are rigorously evaluated by health authorities worldwide to ensure consumer safety. The approval process often involves extensive data submission on efficacy, toxicology, and environmental impact. Key regulatory bodies include the U.S. Food and Drug Administration (FDA), the European Commission (through its Scientific Committee on Consumer Products - SCCP), and similar agencies in Canada, Australia, Japan, and other major markets.

Ensulizole: A Globally Accepted UV Filter

2-Phenylbenzimidazole-5-Sulfonic Acid (Ensulizole) enjoys widespread approval for use in sunscreen products across many major regions. Its safety profile and efficacy have been assessed, leading to its inclusion in permitted lists of UV filters:

  • United States (FDA): Ensulizole is approved as an active ingredient in over-the-counter (OTC) sunscreen products. The FDA has set a maximum concentration limit of 4% for its use. While the FDA has requested additional data on certain sunscreen ingredients, it has emphasized that products containing these ingredients remain safe and available for consumer use.
  • European Union (EU): In the EU, Ensulizole and its salts (potassium, sodium, and TEA) are listed in Annex VI of the Cosmetics Regulation. They are permitted for use in sunscreen products at concentrations up to 8%. The SCCP has reviewed its safety and concluded it poses no risk at these levels.
  • Other Countries: Ensulizole is also approved and utilized in countries such as Australia, Canada, and Japan, often with specific concentration limits that ensure safe and effective use.

Implications for Formulators and Manufacturers

For cosmetic manufacturers and formulators, understanding these regulations is critical for market access and product compliance. Sourcing high-quality ingredients from reliable suppliers like NINGBO INNO PHARMCHEM CO.,LTD. ensures that the ingredients used meet the required standards. As a supplier of cosmetic grade UV absorber and ensulizole sunscreen agent, NINGBO INNO PHARMCHEM CO.,LTD. is committed to transparency and compliance, providing documentation and support to help clients navigate these requirements.

Choosing Compliant and Effective Ingredients

The global acceptance of 2-Phenylbenzimidazole-5-Sulfonic Acid underscores its value as a reliable UV filter. Its ability to provide UVB protection and enhance formulation aesthetics makes it a preferred choice for many product lines. By focusing on ingredients with established regulatory approvals and proven performance, manufacturers can build trust with consumers and ensure the quality of their sun care products.

NINGBO INNO PHARMCHEM CO.,LTD. is dedicated to supporting your product development by providing well-researched and regulatory-compliant ingredients. If you are looking to source 2-phenylbenzimidazole-5-sulfonic acid UV absorber or other essential cosmetic ingredients, our team is ready to assist you with expert advice and high-quality products.