Problem to be Solved and Significance: Exposure to Ultraviolet radiation (UVR) is a risk factor for thedevelopment of skin cancer, and health care agencies recommend that sunscreens be used as a preventativemeasure. Recent legislation in the U.S. and internationally has banned the sale of ingredients that arefundamental to water-resistant sunscreens, creating an urgent need for new products that satisfy existing andemerging legislation.Product and Long-Term Goal: The product of this SBIR will be a wholly biocompatible SPF 30 broad spectrumsunscreen cream, sold in 6-oz tubes, that satisfies FDA's criteria to be labeled as "Water Resistant (80 min)' andis based on the Nanometics (d.b.a. PHD Biosciences [PHD]) proprietary elastomer technology. Successfuldevelopment of this sunscreen product directly addresses the mission of the National Cancer Institute byimproving protection against UVR and decreasing the risk of skin cancer.Technological Innovation: The PHD sunscreen incorporates PHD's proprietary biodegradable elastomertechnology, which is the first plant derived elastomer for topical products that provides water resistance, iscompatible with all Food and Drug Administration approved UV filters, and recapitulates the favorable aestheticproperties of silicone elastomers.Specific Aim #1. To demonstrate that the PHD Sunscreen is water resistant for at least 80 min on healthyvolunteers. Studies in this Aim will be conducted under FDA guidance and will demonstrate the feasibility thatthe PHD sunscreen is resistant to removal with water after 80 min of continuous immersion in water. SuccessCriterion: This Aim will be successful if after 80 min of water immersion, the mean SPF falls within one standarddeviation of the pre-immersion SPF of 30.Commercial Opportunity: The global sunscreen market is projected to exceed $2.5 billion by 2023. Primaryand secondary market research supports the need for the PHD Sunscreen to meet the emerging needs createdby new legislation. Phase II SBIR studies will include additional studies to confirm safety on a larger number ofvolunteers; compare performance to leading commercial sunscreens; and optimize the chemistry,manufacturing, and control (CMC) processes to produce the product at commercial scale. PROJECT NARRATIVE
Exposure to ultraviolet radiation (UVR) is a known risk factor for the development of skin cancer, which is the
most common form of cancer in the United States. Water resistant sunscreens are available but do not satisfy
emerging global environmental regulations. This Phase I SBIR proposal seeks to further the development of a
long-wear SPF 30 sunscreen with high affinity and improved retention on human skin. The novel sunscreen
provides extended protection from UV-mediated toxicities and its continued development remains a significant
priority. Biological Sciences ; Biologic Sciences ; Bioscience ; Life Sciences ; Biomass ; Malignant Neoplasms ; Cancers ; Malignant Tumor ; malignancy ; neoplasm/cancer ; Carbon ; Skin Cancer ; Malignant Skin Neoplasm ; malignant skin tumor ; Chemistry ; Diagnosis ; Elastomers ; Esthetics ; Europe ; Excipients ; Florida ; Goals ; Human ; Modern Man ; Incidence ; Statutes and Laws ; Legislation ; Market Research ; Mission ; Plants ; Research Support ; Risk ; Risk Factors ; Safety ; Sales ; Silicone Elastomers ; Silicone Rubber ; Sunlight ; sun light ; Sunscreening Agents ; Sunblock ; Sunscreens ; sun block ; sun screen ; Swimming ; Technology ; Time ; Ultraviolet Rays ; Actinic Rays ; UV light ; UV radiation ; UV rays ; ultra violet light ; ultra violet radiation ; ultra violet rays ; ultraviolet light ; ultraviolet radiation ; United States ; United States Food and Drug Administration ; Food and Drug Administration ; USFDA ; Water ; Hydrogen Oxide ; falls ; Healthcare ; health care ; Mediating ; Bathing ; Baths ; Ecosystem ; Ecologic Systems ; Ecological Systems ; Tube ; base ; Label ; sensor ; improved ; Phase ; Link ; Cutaneous ; Knowledge ; American ; biocompatibility ; biomaterial compatibility ; Performance ; photoprotective ; photoprotection ; success ; bioresorbable polymer ; degradable polymer ; biodegradable polymer ; Toxicities ; Toxic effect ; novel ; technological innovation ; Abscission ; Extirpation ; Removal ; Surgical Removal ; resection ; Excision ; Sun protection factor ; Regulation ; Modeling ; Property ; cancer care ; Manufacturer ; Manufacturer Name ; Skin ; U.V. protection ; ultraviolet protection ; UV protection ; preventing ; prevent ; Cream ; Address ; Affinity ; International ; NCI Organization ; National Cancer Institute ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Process ; Development ; developmental ; Phototoxicity ; UV Radiation Exposure ; Exposure to ultraviolet radiation ; UV exposure ; Ultraviolet Radiation Related Exposure ; Ultraviolet radiation exposure ; ultraviolet exposure ; consumer demand ; global environment ; global environmental ; design ; designing ; Outcome ; Resistance ; resistant ; volunteer ; healthy volunteer ; ultraviolet damage ; UV damage ; ultra violet damage ; commercial application ; skin organogenesis ; Skin development ; Preventive measure ; Preventative measure ; clinical development ; Immersion ; Home ;
