Changing regulatory landscape for sun care products

Earlier this year, the US Food and Drug Administration issued a proposed rule aiming to improve the quality, safety, and effectiveness of sunscreens. The proposal updates regulatory requirements for most sunscreen products in the US - addressing active ingredient safety, dosage forms, sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to labelling, intending to make it easier for consumers to identify key product information. [1]

According to National Park Services, 14,000 tons of sunscreen are released into coral reef areas annually as they’re washed off in the oceans.

The agency stated that, to date, they only consider two of the 16 marketed active ingredients - zinc oxide and titanium dioxide - generally recognized as safe and effective (GRASE) for use in sunscreens. As the US is currently the largest suncare market globally, reaching a value of $1.45B USD in 2017, the proposed changes are expected have significant impact on the industry. [2]

Impact on reef ecosystems

In addition to human health and safety considerations, the suncare industry is also facing change as a result of increased consideration by consumers and legislators on the environmental impact of these products. Recent studies allege that commonly used organic UV filters, specifically oxybenzone and octinoxate, may be damaging to reef species and contribute to the widespread bleaching of coral reefs. [3] According to National Park Services, 14,000 tons of sunscreen are released into coral reef areas annually as they’re washed off in the oceans. While numerous factors including climate change, pollution, overfishing, and coastal development have been largely linked to reef degradation, initial research on oxybenzone and octinoxate has spurred controversy over the long-term impact these chemicals have on reef ecosystems. These concerns led the state legislature of Hawaii to pass a law banning the distribution of sunscreens containing oxybenzone and octinoxate as of 2021, with the City of Key West, Florida and the Republic of Palau implementing similar bans.

Drivers for biodegradable ingredients which boost sunscreen efficacy

Ongoing controversy surrounding the environmental impact of sunscreens and proposed regulatory changes in the U.S. are leading brands to re-evaluate the design of sun care formulations, examining functional ingredients as well as UV filters. An opportunity exists for innovation of natural mineral-based formulations, which are generally considered to be less irritating and may carry “reef-friendly” claims - pending other formulation considerations. To further support natural and environmentally-friendly product claims, new product development teams are seeking biobased ingredients and those which are more readily biodegradable.

Biodegradable film-forming polymers are an attractive category of ingredients to consider as part of these formulation efforts. Traditionally, acrylate and vinyl polymers have been used to impart water-resistance and improve SPF in sun care products. Although advancements across this category have delivered technologies providing improved aesthetics, superior water-resistance, and enhanced SPF, an opportunity for more biodegradable options with comparable efficacy remains.

Solutions for biodegradable film formers delivering superior benefits

Polyester chemistry provides a versatile platform for the development of film formers that meet consumer-driven needs without compromising on performance. Traditional acrylate and vinyl film forming polymers are inherently more resistant to biodegradation as opposed to polyester film formers. In addition, sunscreens formulated with polyesters have been shown to provide equivalent or improved SPF and water resistance values. When combined with biodegradable emollient esters, polyesters provide outstanding aesthetics in sun care applications, eliminating the need for environmentally-persistent silicones frequently used to achieve desirable skin feel. The high polarity of the hydrophobic polyester-ester matrix improves solubilization of organic UV filters and dispersion of inorganic UV filters, hence providing for greater formulation stability and higher UV absorption in thin films.

LexFilm Sun Natural MB (INCI: Capryloyl Glycerin/Sebacic Acid Copolymer) is a film-forming polyester derived from 100% biobased feedstocks: coconut, palm, and castor bean oil. The patented [4] polymer design was guided by the 12 Principles of Green Chemistry, complies with COSMOS and NSF/ANSI 305 requirements, and contains 100% USDA certified biobased content. Its hydrophobic backbone imparts superior water-resistance in inorganic sunscreen formulations, offering enhanced performance compared to leading synthetic film-forming polymers, such as VP/Eicosene Copolymer and VP/Hexadecene Copolymer.

Comparison of water resistance and SPF; 2% polymer in test formulation

In addition, the novel film-forming technology was designed to offer improved inorganic filter dispersibility and is highly miscible with organic UV filters. The viscous pourable fluid form simplifies formulation processing and ensures homogeneous incorporation of the polymer, delivering optimal SPF protection. These benefits, in combination with the exceptional aesthetic appeal of LexFilm Sun Natural MB, make the biodegradable polymer an ideal option for cutting-edge sunscreen development. LexFilm Sun Natural MB addresses consumers’ demand for natural ecofriendly ingredients, while supporting brands in their efforts to bring true innovation to the market in compliance with an everchanging regulatory environment.