Assessing a Natural Product Plus Bioadhesive Nanoparticle (BNP) Sunscreen

The primary objective of this study is to evaluate the effects of a novel sunscreen formulation by assessing the extent of ultraviolet radiation (UVR)-induced direct and indirect cellular and DNA damage to human skin, in the presence vs absence of the sunscreen, in a population of healthy adults with fair skin (Fitzpatrick Scale type I, II or III).

Inclusion Criteria:Provision of signed and dated informed consent formStated willingness to comply with all study procedures and availability for the duration of the studyWomen of child-bearing potential must have negative urine pregnancy testIn good general health as evidenced by medical historyFair skinned with Fitzpatrick Scale skin types I, II or III using the following Skin Type and Sunburn and Tanning History (based on the first 30-45 minutes of sun exposure after a winter season of no sun exposure):I always burns easily; never tans (sensitive)II always burns easily; tans minimally (sensitive)III burns moderately; tans gradually (light brown) (normal)Exclusion Criteria:Individuals with active or a history of dermatological disorders-psoriasis, rosacea, eczema, vitiligo, lupus, dermatomyositis, etcIndividuals known to be subject to any abnormal responses to sunlight, such as phototoxic or photoallergic response.Current use of medication (topical or systemic) that is known to produce abnormal sunlight responses.History of skin cancer (such as basal cell carcinoma, squamous cell carcinoma, melanoma)Family history of melanomaPresence of sunburn, suntan, scars, active dermal lesions or uneven skin tone on the test site.Skin type falling under the Fitzpatrick Scale skin types IV, V or VI using the following Skin Type and Sunburn and Tanning History (based on the first 30-45 minutes of sun exposure after a winter season of no sun exposure):IV Burns minimally; always tans well (moderate brown) (normal)V Rarely burns; tans profusely (dark brown) (insensitive)Use of sunscreen within the last week on the test site area (such that UV filter penetration may confound results)Febrile illness within 48 hours.Women with a positive urine pregnancy test