The Florida SCC Sunscreen Symposium is a traditional gathering of the sunscreen manufacturing and supplier industry. It is held biannually in mid-September. Also, Covid-19 could not stop it, since its peak fell right in between the 2019 and 2021 edition. As a positive remainder of the pandemic, there are still some video sessions, especially with speakers from the FDA, who have limited travelling budgets.
I attended the sunscreen symposium for the fourth time in a row and I am happy to share some highlights of its.
1) Continuous Education Program (CEP), Wen Schroeder, (Seki Cosmeticals LLC)
For the second time, Wen Schroeder gave a full day (6h) CEP course, this time focusing on Sunscreen Claims and Regulatory Overview. She is best qualified, as the president of SEKI Cosmeticals, a consulting company she founded in 2007. In addition to serving the European Commission as a key expert, leading and supporting the ASEAN-EU Integration Programmes in the field of GMPs and testing of cosmetic & pharmaceutical products, she was Science/Technology Advisor to Taiwan External Trade Development Council in similar regulatory & scientific advisory roles. Ms. Schroeder has served on various scientific committees for the Personal Care Products Council and is active in the Society of Cosmetic Chemists and the Regulatory Affairs Professional Society.
The take home message for me were her insight and understanding of the FDA, e.g. that sunscreens are regulated as drugs and will keep on staying regulated as drugs, although this question kept popping up during the symposium. Also, MOCRA1 will not change anything.
Wen Schroeder also informed about the “Anti-Sunscreen” trend in the US. She was impressed about an article in RollingStone that is trying to debunk this trend.
I am quoting directly from the RollingStone article2 :
Anti-Sunscreen Influencers Want to Fry Your Skin – Natural “wellness” gurus, conspirituality peddlers, and trad life propagandists have joined forces to increase their collective risk of cancer – By Miles KLEE JULY 4, 2023
THIS SUMMER, LIKE many before, a lot of people won’t wear sunblock. The difference you might notice this year is just how many are proudly posting about it. James Middleton is a fitness coach in the U.K., with a wellness brand that reaches about a quarter of a million people on Instagram. While impressive in its own way, this makes him neither a dermatologist nor an oncologist. But on Twitter last month, Middleton urged followers to dispense with sunscreen, arguing that the vitamin D produced by the human body when exposed to sunlight “make it almost impossible to develop an autoimmune disease.”
(That sounds like hyperbole because it is; the benefits of vitamin D supplements are often overstated.)
“Think about it for a minute,” Middleton wrote. “They [pharmaceutical and health care companies] need you to believe that the sun is bad.” He included a pair of images from a TikTok video that made a similar point, suggesting that corporate interests have invented the myth of “dangerous” ultraviolet radiation from the sun in order to sell you a product — in this case, topical creams and sprays that prevent sunburn and skin cancer — that you don’t really need. It’s all a scam! Go forth and sizzle to a crisp!
That Middleton is blaming an amorphous “they” for the supposed sunscreen racket puts him squarely in a conspiratorial mindset — and he’s hardly alone. Across online natural health communities, influencers are peddling the lie that the sun doesn’t cause cancer, while arguing that it is, in fact, the use of sunscreen that can make you ill. Sometimes, this notion is connected to romanticized concepts of traditional (or “trad”) lifestyles, coupled with the assumption that our ancestors didn’t use sun protection. (They did.) Those who espouse “clean living,” meanwhile, may count sunscreen as a contaminant alongside supposedly harmful substances like seed oils, which have also been falsely characterized as “toxic.”
2) Formulation Session
The two consultants Julian Hewitt, JPH SunCare Technologies Ltd. and Mark Chandler, ACT Solutions Corp, focused on two main objectives: improving the aesthetic properties of formulations and improving the efficacy of the existing active ingredients. Julian reminded us to combine emollients to create a “spreading cascade” to optimize smoothness during application3 and also the use of water-soluble UV filters to counteract the greasier feel of oil-based actives. He also gave tips how to improve the skin feel of inorganic filters, where coating technology is key4 . Furthermore, Julian elaborated on SPF Boosters by calling out their possible mechanisms: UV absorption, Erythema reduction, film-forming/optimization of rheology and light scattering. In the second part, Mark Chandler elaborated along his eight “Elements”: Dampened Dispersing, Ferocious Feruloate, Gregarious Glycolipid, PHA for Everyday, Precocious PDA, Supercilious Silica, Tackling Titanium, and Zest for Zinc. Unfortunately, he did not provide any references on his slides.
Maitree Kanjilal, KOBO presented Evaluating Hybrid Sunscreens to Meet the Needs for Inclusivity and Safety. She showed that hybrid sunscreens (containing inorganic and organic UV filters) are more inclusive of all skin types and have higher SPF potential than mineral only sunscreens. The effect of particle size on transparency is demonstrated in figure 2. Maitree also showed how incorporating sunscreen boosters minimize actives and achieve SPF 50+ in hybrid sunscreens.
Particle Size, left to right: 263, 100, 60, 30, 20nm
Iva Teixeira is the Co-founder of the Good Face Project, a chemistry informatics AI company powering up the fastest growing Cosmetics Formula Management, Regulatory Compliance and Innovation. Her talk entitled Threading All the Needles – Sunscreen Compliance at the clean Retail analyzed the retail policies of the 30 largest distributors, such as Walmart, amazon, CVS, Kroger etc. She showed how many of the “Best of Beauty allure award winners” would comply with the house-rules of different sales segments: Mass Beauty Retail (6 comply out of 23), Specialty Beauty Retail (14/23) and Clean Retail – Specialty and Mass (1/23). The major driver behind house-internal bans are often UV filters, organic and inorganic, but also other ingredients. This situation leads obviously to a lot of uncertainly in the industry.
As an outlook, Iva Teixeira expressed some hope. She sees an emerging trend that more and more companies will align their policies along the strongest official regulation worldwide in order to be flexible in trade. As it looks like at the moment this will be the European Cosmetics and the Chemical Regulations.
3) Traditional and New UV Filters
The environmental impact of UV filters has become a hot topic in recent years. The announced speaker was Charles Menzie, Committee Chair National Academies Committee on Environmental impact of Currently Marketed Sunscreens and Potential Human Impacts of Changes in Sunscreen Usage. The 400+ pages NAS report has been mentioned in this column before5 . Instead, Carys Michelmore, U of Maryland, who was also part of the NAS committee, presented the results of the NAS report, via video connection. Carys Michelmore has been working in this particular field of UV filters for the last 7 years. Her Critical Review has also been mentioned in this column before6 , hence we do not have to repeat the NAS report and her conclusions this time.
Worth mentioning are also the two speakers from the FDA, Linda Katz, Director, Office of Cosmetics and Colors, CFSAN (FDA) and Chinmay Shukla (FDA, Office of Clinical Pharmacology).
Linda Katz gave an overview of the US Cosmetics Regulatory Framework. FDA’s Regulation of cosmetics goes back to 1938 and is now being revised under the Modernization of Cosmetics Regulation Act (MoCRA), enacted in December 20221 .
Chinmay Shula provided an overview of the regulations under the NDA process versus a monograph process that would be applicable to sunscreens. He explained details of the clinical pharmacology evaluations for topical sunscreens. The core concepts and design of a maximum use study (MUsT) and the use of pharmacokinetic (PK) data obtained in the MUsT to determine the systemic safety of the sunscreen were covered in detail.
Finally, it was the turn of Carl D’Ruiz, DSM-Firmenich (my ex colleague from Ciba Specialty Chemicals) to show what this all means in practice (Figure 3). Carl is optimistic that this “new” UV Filter will be approved by the FDA next year, i.e. 24 year after Ciba SC had launched BEMT under the trade name Tinosorb© S and 7 years after DSM had launched it under the name Parsol© Shield. Let’s hope that this will be the case.
4) SPF a never ending story?
There was also an interesting session on “SPF”, which has been very well received. Jeff Field, Florida Skincare Testing Inc. presented deviations of SPF-Results, especially since the revision of the gold standard ISO 24444. Sebastien Miksa, HelioScreen, France, elaborated on the progress in the ISO committee ISO/TC 217, working group WG 7, and I, Uli Osterwalder, SunProtectionFacilitator GmbH discussed if we need to go back to SPF “Outdoor-Testing” to be closer to “reality”, a topic that has already been covered in this column before7 .
We will discuss these topics in the next column, after my similar presentation at the SEPAWA-Cosmetic Science Conference in Berlin in October.
References
- FDA, MOCRA, Modernization of Cosmetics Regulation Act of 2022, https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022
- Klee M, Anti-Sunscreen Influencers Want to Fry Your Skin, RollingStone, 2023-07-04
- Bruening S, et al, Role of emollients and emulsifiers in sunscreen formulations. In: Shaat NA (ed) Sunscreens: Regulations and Commercial Development, 3rd edn. (2005) Taylor & Francis, Boca Raton, pp. 449-460
- McNeil et al, Assessing the sensory performance of novel coating technology. SOFW Journal 140(7): 2-7 (2014)
- National Academy of Science (NAS) Review of Fate, Exposure, and Effects of Sunscreens in Aquatic Environments and Implications for Sunscreen Usage and Human Health, Washington (DC): National Academies Press (US); 2022 Aug 9. Available from: https://www.ncbi.nlm.nih.gov/books/NBK587274/doi: 10.17226/26381
- Mitchelmore CL, Burns EE, Conway A, Heyes A, Davies IA. A Critical Review of Organic Ultraviolet Filter Exposure, Hazard, and Risk to Corals. Environ Toxicol Chem. 2021 Apr;40(4):967-988. doi: 10.1002/etc.4948. Epub 2021 Feb 2. PMID: 33528837; PMCID: PMC8048829.
- Osterwalder Uli, Back to SPF-Testing Outdoors?, Sweep the Sun, EURO-COSMETICS Newsletter, 2022-10-24, https://www.eurocosmetics-mag.com/sweep-the-sun/
Uli Osterwalder
Uli Osterwalder studied Chemical Engineering at ETH Zurich, Switzerland and at the University of Houston in Houston, Texas. He joined Ciba-Geigy in Basel in 1979 where he first developed a Phosgene Generator in central process development. Later he developed his leadership skills in Project Management and Process Analytics. At Ciba Specialty Chemicals Uli Osterwalder helped establish new business development in Fabric Care and Personal Care. After the acquisition by BASF SE he became Senior Marketing Manager and Scientific Adviser in Sun Care in Ludwigshafen and Duesseldorf.
2016 he came back to Basel, working for DSM as senior Senior Scientific Adviser suncare for two years. 2018 he started his own company, Sun Protection Facilitator GmbH and is committed to contribute to further improvements in sun protection. Uli Osterwalder works for ISO on the development of new UV protection assessment methods and is now chairing the technical committee ISO TC/217 (Cosmetics). He is author and co-author of numerous scientific articles and book chapters on sun protection.
