PARSOL® ShieldFDA ApprovalComing Soon

Good as it might feel to catch some rays, there is no escaping the fact that spending time in the sun carries a risk for skin appearance and health. Painful sunburn and premature skin aging are two well-known hazards but the statistics on skin cancer are especially sobering. In the U.S., diagnoses of new melanoma cases have increased by 42 percent in the last decade (2015-2025), more people are diagnosed with skin cancer each year than all other cancers combined and more than two people die of this illness every hour.¹

Consistent use of sunscreen is one of the most effective ways to guard skin against the long-term effects of UV radiation and could even help reduce the risk of developing melanoma by up to 50 percent.² However, many people still do not realize how often they need to wear or reapply sunscreen. Others are wary of using it at all due to environmental concerns or because they dislike how traditional products feel on their skin. 

The formulation dilemma

For consumers to adopt healthy sun protection habits, they need access to broad-spectrum products that are safe, effective, pleasant to apply and wear, and sustainable. As all formulators know however, balancing adequate UV protection, photostability, solubility, ingredient compatibility, skin health, sensory properties, regulatory compliance and environmental impact is quite an ask.

The challenge is even greater in the U.S. market where the set of approved UV filters is much narrower—16 compared to the 27 filters available in Europe, of which only 7 are commonly used in sunscreens. The last time a new sunscreen ingredient was added to the OTC sunscreen monograph for use in the U.S. was back in 1999!

After 25 years however, change is coming, as the FDA is about to approve PARSOL^® Shield—the high-performance UV filter from global market leader dsm-firmenich—and grant it 18 months’ exclusivity in the U.S. market. 

A breakthrough 

This breakthrough is the culmination of six years of advocacy and scientific data production by dsm-firmenich to demonstrate that PARSOL^® Shield meets the necessary safety and efficacy criteria to be “Generally Regarded as Safe and Effective” (GRASE) under the FDA’s new guidelines for over the counter (OTC) sunscreen ingredients.  

Thanks to this data, and the results of testing under the FDA’s new maximal usage trials for topical ingredients (MUsT), PARSOL^® Shield will soon be approved for use in OTC sunscreen products at a maximum concentration of 6%. As the first new UV filter to be approved in 25 years, this is a major win for public health and skin cancer prevention in the U.S. It triggers a new era for American consumers wanting modern, sustainable and lighter-textured, broad-spectrum solutions available in other parts of the world and a real must-have for innovative suncare manufacturers.

PARSOL® Shield: six key advantages

Outside the U.S., PARSOL^® Shield has been approved for many years. It is the preferred UV light absorber for global formulators for six key reasons:

Superior performance

Based on UV absorption, PARSOL^® Shield is the most efficient broadband UVB-UVA filter available, providing outstanding levels of protection at lower concentrations than its competitors. Unlike many other UV filters, it still delivers high levels of SPF protection in minimalistic formulations—so it can meet the needs of consumers wanting lighter, smoother and “cleaner” suncare products too.  

Holistic protection

Thanks to its significant contribution to UVA protection, PARSOL^® Shield addresses the 320nm wavelength “gap” between UVB and UVA rays, reducing the risk of under-protection. This makes it a powerful move to ensure that formulations meet the FDA’s proposed requirements on broad-spectrum protection.

Ideal for stabilizing avobenzone

PARSOL^® Shield is an effective and compatible stabilizer for Avobenzone, the only approved UVA filter in the U.S. PARSOL^® Shield provides a key and more modern alternative to the traditional and increasingly controversial U.S. choice of Octocrylene. As well as offering an Octocrylene-free, UVA-compliant solution, the PARSOL^® Shield-Avobenzone combination is Europe’s preferred option.

Environmental advantages 

After the FDA’s approval, PARSOL^® Shield will be the best-in-class, high-performance UV filter in the U.S. market. A remarkable suncare solution with low environmental impact, delivering superior SPF at lower concentrations than competing UV filters. It also demonstrates no adverse effects when tested against the European Chemical Agency’s widely recognized PBT criteria of Persistence (P), Bioaccumulation (B), Mobility (M), and Toxicity to fish, invertebrates, algae and micro-organisms (T). As one of the most eco-friendly and high-performance UV filters globally, it is an invaluable choice for more sustainable, eco-conscious formulations.

Long term future ahead

The narrower range and combinations of UV filters approved in the U.S. can limit formulation choices, but PARSOL^® Shield is compatible with permitted organic UV filters such as Avobenzone and Ensulizole, and with the mineral options of titanium dioxide and zinc oxide—the only other two UV filters with GRASE approval. With PARSOL^® Shield at the core of an SPF formulation, developing high-performance sun care solutions that meet the demands of both global and U.S. markets becomes significantly more streamlined. 

dsm-firmenich quality and services

PARSOL^® Shield is produced to the high Good Manufacturing Practices standards, ensuring product quality and processes that comply with FDA requirements for OTC drugs. PARSOL^® Shield defined USP monograph standards for BEMT according to FDA approved quality. It also comes with the backing of dsm-firmenich’s comprehensive package of services, providing expert support every step of the way. This includes the use of state-of-the-art SUNSCREEN OPTIMIZER™ formulation tool, market insights and trends capabilities, eco-profiling, sensory and formulations expertise and technical and regulatory support on the ground in different regions, including the U.S.

PARSOL^® Shield’s upcoming FDA approval sets a new benchmark for elevated sun protection in the U.S. and will entirely change the suncare landscape and formulation approach. The time is set for innovation, and with dsm-firmenich’s 40+ years of expertise in developing and combining UV filters, and formulating for the U.S. and global markets, there is no need to start from scratch. To get ahead and bring the next generation of broad-spectrum sun protection to consumers everywhere, partner with dsm-firmenich and start using PARSOL^® Shield today.

Discover more about how PARSOL^® Shield is making sun care history. www.dsm-firmenich.com/en/businesses/perfumery-beauty/beauty-care/products/parsol-shield.html 

References

1. Skin Cancer Facts https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/
2. Green AC, Williams GM, Logan V, Strutton GM. Reduced melanoma after regular sunscreen use: randomized trial follow-up. J Clin Oncol 2011; 29(3):257-263.