New Day Skin Spray

New Day Skin Spray is a non-sterile skin emulsion spray designed to manage atopic dermatitis and dry skin by maintaining a moist skin and wound environment. A thin layer is applied to affected areas for up to 28 days or until symptoms subside, forming a breathable protective layer that promotes healing.

The device is an emulsion spray formulation containing xanthan gum, silk fibroin (proteoglycan), water, caprylic/capric triglyceride (MCT oil), glycerin, sodium benzoate, and citric acid with no corticosteroids. It is non-sterile, single-use, with a pH of 5.0–6.0 and viscosity of 200–2,100 cP. The spray delivery format differs from the predicate's emulsion form but achieves the same skin barrier and moisturization mechanism of action.

ISO 10993-5 (cytotoxicity), ISO 10993-10 (guinea pig maximization sensitization), ISO 10993-23 (skin irritation), ISO 10993-6 (local effects after implantation), ISO 10993-11 (subacute systemic toxicity), USP <51> (preservative efficacy), USP <61> (microbial enumeration), USP <62> (absence of specified microorganisms), and USP <151> (material-mediated pyrogenicity). FHSA dermal toxicity study was also conducted in lieu of ISO 10993-11 acute systemic toxicity.

New Day Skin Spray is substantially equivalent to the predicate EpiCeram Skin Barrier Emulsion (K052643) because both are non-sterile, unclassified wound dressing devices with the same product code (FRO) and intended use for managing skin dryness and atopic dermatitis through emollient moisturization and skin barrier protection. All performance testing, including biocompatibility and preservative efficacy, met acceptance criteria and did not raise new safety or effectiveness questions.