Key Takeaways:
Health Canada has expanded its Secondary Sunscreen Monograph to include PARSOL Shield (INCI: bemotrizinol), a broad-spectrum UV filter widely used in sunscreen formulations in Europe and other international markets. The update allows the ingredient to be used in products where sun protection is not the primary function, such as daily skincare and cosmetics that incorporate SPF.
Previously, bemotrizinol was permitted in Canada, but only under the Primary Sunscreen Monograph, meaning it could be used in products specifically marketed as sunscreens. With the revision, manufacturers can now formulate with the UV filter in secondary sunscreen products, including moisturizers, serums, and makeup that offer incidental sun protection alongside other benefits. Under the updated framework, bemotrizinol may be used at concentrations of up to 6% in secondary sunscreen formulations.
PARSOL Shield is marketed by DSM‑Firmenich and is known for providing broad-spectrum UVA and UVB protection while maintaining high photostability. Because the filter does not degrade easily under sunlight, it is often used to stabilize other UV filters in sunscreen systems and to improve overall protection.
The ingredient has been approved for use in sunscreens across several regions for years, including Europe and Asia. However, regulatory timelines differ globally, and because sunscreen is regulated as an over-the-counter drug in the US, it can take many years for a new ingredient to gain FDA approval.
Much to DSM-Firmenich’s relief, in December of last year, the FDA proposed adding bemotrizinol to the list of approved UV filters on the sunscreen monograph, the first to be recommended in the US since 1999.
PARSOL Shield is currently in the final stages of FDA approval, with a final order for its inclusion as a Generally Recognized as Safe and Effective (GRASE) active ingredient in the US. The finalized sunscreen monograph is expected in June 2026.
The update mirrors Canada’s evolving approach to sunscreen regulation and aligns with broader industry demand for more versatile UV filters that can be incorporated into multifunctional products. In recent years, skincare and cosmetic brands have increasingly positioned sun protection as part of everyday routines rather than as a stand-alone step, leading to growth in hybrid formulations such as SPF moisturizers and complexion products with built-in UV protection.
By permitting bemotrizinol in the secondary monograph, Health Canada effectively broadens the formulation options available to brands seeking to deliver sun protection in more lightweight or multifunctional products. The filter’s strong absorption across both UVA and UVB wavelengths, combined with its stability under UV exposure, has made it a widely used component in many international sunscreen systems.
The decision also highlights ongoing regulatory divergence between North America and other markets regarding sunscreen innovation. While Canada now permits bemotrizinol in both primary and secondary sunscreen formulations, the US looks forward to a finalized monograph for itself later this year.
For formulators and ingredient suppliers, the expanded approval represents a regulatory shift that may support the development of new SPF-containing skincare and cosmetic products in the Canadian market, particularly as consumer demand for daily sun protection continues to grow.