COVER STORY

PARSOL® Shield making history post-FDA Approval:
A Breakthrough in Sunscreen Innovation.


JOCHEN KLOCK.1, CARL D’RUIZ.2, TINA VOGT3

  1. Director, Global Regulatory Affairs Beauty & Care, dsm-firmenich
  2. Sr. Business Development Manager, Beauty & Care North America, dsm-firmenich
  3. Director, Global Marketing Sun Care, dsm-firmenich

Although skin health is now a cornerstone of many a beauty routine, there’s still a tendency to throw caution to the wind when warmer, sunnier weather arrives. Too many people are still not taking the steps they need to protect their skin in the sun.

From sunburn, to photoaging, to skin cancer, the damaging effects of UV exposure are well recognised – and the data here speaks for itself. According to the US Skin Cancer Foundation (SCF), an estimated 80% of skin ageing in Caucasian women is caused by the sun. More seriously, in the USA, 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. One in five Americans will develop skin cancer by the age of 70, and this year alone, it is estimated that the number of new melanoma cases diagnosed will increase by 5.9% (1).

Protecting skin and addressing barriers to sunscreen use

Regular use of sunscreen with an SPF of 15 or higher has been found to help reduce the risk of developing melanoma by as much as 50 percent (2), but many people still do not realise how often they need to wear (or reapply) sunscreen. Others may be reluctant to use it at all due to environmental concerns or dislike of how more traditional products feel on the skin. In the USA, there has also been the challenge of having just 16 UV filters approved for use in sun protection products, of which only 7 are commonly used in sunscreens, compared to 27 filters in Europe – limiting the options significantly for formulators and consumers alike. Until today, the last time a new sunscreen ingredient was approved for use in the USA was back in 1999.


At dsm-firmenich, as part of our ongoing commitment to promoting public skin health, for years we have been sponsoring the SCF’s annual screening and education roadshow, Destination Healthy Skin. In 2024 we also hosted our third annual Safer Under theSun Day in Washington DC. An event for stakeholders from the worlds of medicine, public health, personal care and sunscreen development, which provides a forum for addressing barriers to sunscreen innovation in the USA. It also advocates for industry-government partnerships to advance new over the counter (OTC) sunscreens, so that American consumers can benefit from the broad-spectrum UV protection and sensory properties modern UV filters can provide.


Our advocacy is beginning to bear fruit. For the first time in 25 years, the FDA is on track to approve our PARSOL® Shield and grant it 18 months of exclusivity in the USA market. This approval will allow PARSOL® Shield to be used in over-the-counter (OTC) sunscreen products at a maximum concentration of 6%.


This milestone is highly significant for public health and skin cancer prevention in the United States. American consumers will finally have access to a new broad-spectrum UV filter that can be formulated to meet the needs of different skin types. This marks the first new UV filter approval in the USA in 25 years, representing a major win for public health.


Outside of America, PARSOL® Shield has been approved and is a preferred UV light absorber by global formulators for a long time. Based on its UV absorption profile, it is the most efficient broadband UVB-UVA filter available, providing high levels of protection at low concentrations. For the past six years, dsm-firmenich has been cooperating with the FDA to obtain a determination that PARSOL® Shield is Generally Regarded as Safe and Effective (GRASE) under the OTC monograph.


Now, having met the requirements of safety and efficacy under the new FDA OTC guidelines for demonstrating that an OTC sunscreen active ingredient is GRASE and conducting the maximal usage trials for topical ingredients (MUsT), we have provided the necessary data to the FDA to support the GRASE status of our PARSOL® Shield sunscreen ingredient. With this data, it will soon be approved as a trusted UV filter in the USA.

Take skin protection global

PARSOL® Shield delivers high levels of broad-spectrum, UVB and UVA protection and meets the new UVA requirements for a 320 nm wavelength “gap”. Thanks to its efficacy even at low concentrations, it scores highly for environmental performance, making it an invaluable choice for more eco-conscious formulations. Its compatibility with organic and inorganic UV filters means that it is suitable for a wide range of suncare applications. Formulators will love it as it can be used to stabilize Avobenzone – very often a challenge during the sunscreen formulation process. It also offers a key and more modern alternative to Octoycrylene. Now, with a GRASE determination to complement its regulatory approvals in multiple other regions, PARSOL® Shield clears the way for forward-thinking sun care actors to take high performance skin protection global!

Sun care fit for the future

Regular sunscreen use can play an important role in helping to protect skin against UV-induced damage like premature photoaging and skin cancer. However, for consumers to develop safe sun protection habits, they must have confidence that the products they choose are effective, pleasant to apply and wear, and respecting the environment. With its versatility and proven performance, PARSOL® Shield offers boundless opportunities for innovation, especially with its pending FDA approval and global registration status. This is all backed by dsm-firmenich’s expertise in sensory and formulations, technical and regulatory support and eco-profiling. Are you ready to create the next generation of UV protection? Join us in creating a brighter future under the sun.

dsm-firmenich. We bring progress to life.

Discover more about how PARSOL® Shield is making sun care history here

ABOUT US

Gale & Cosm offers a wide range of Personal Care ingredients, many of which are registered with the Vegan Society, and are COSMOS and HALAL approved. Research and innovation are the core of the Company.


Our Company is specialized in natural-derived emulsifiers, water soluble and dispersible oils, and our lines include ingredients which are perfect to enrich personal care formulations. All ingredients are characterized by emolliency and eudermic properties, and are very easy to include in different types of preparations.

Contact

info@galecosm.com

web: www.innospec.com

www.galecosm.com


References and notes

  1. https://www.skincancer.org/skin-cancer-information/skin-cancer-facts/#aging
  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. https://pubmed.ncbi.nlm.nih.gov/21135266/​​​​​​​