SBIR Phase II: Production and formulation of a safe and natural sunscreen to replace ingredients harmful to human and environmental health

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is the development of a safe, effective, and sustainably-produced natural sunscreen compound, gadusol, to replace harmful ingredients widely used in current sunscreen products. Two to three million cases of skin cancer are reported globally each year, including 132,000 cases of melanoma. In 2015, the U.S. Centers of Disease Control and Prevention reported 80,442 new cases of melanomas of the skin in the U.S. The potential exists to reverse this trend with effective, safe, aesthetically-pleasing sun protection products that provided long-lasting full-spectrum UV protection. Sustainable production of gadusol and the assurance of its safety and efficacy will enable such products to be developed. With a global sunscreen product market of $16.5 billion and growing, along with the demonstrated need for natural, safer sunscreen actives, this project is poised to have a worldwide, long-term impact on national and global health. This SBIR Phase II project will demonstrate the feasibility of sustainably producing gadusol, a natural, marine-based compound with proven sun protection capability. Recent research has documented that widely used sunscreen ingredients pose hazards to the environment and possibly to human health, leading to bans on popular sunscreen products. Mineral active compounds such as ZnO and TiO2 are safer substitutes but pose aesthetic disadvantages, leading to products that many consumers dislike. Gadusol has the potential to replace some of these widely-used chemical actives as a safe, effective, and natural UVB blocker. The technical scope proposed includes overcoming obstacles to sustainable production of gadusol using the tools of synthetic biology, establishing gadusol's safety through standard pre-clinical tests, and assessing its efficacy and suitability in prototype formulations (SPF value). Successful completion of this project will reduce the risks of adopting gadusol as a new sunscreen ingredient, enable its commercial production, and provide essential safety data prior to initiating clinical testing required for FDA approval. This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.