Label: SKINFUSE SHIELD SPF 30- zinc oxide cream

  • NDC Code(s): 59958-240-01
  • Packager: Owen Biosciences, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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Drug Label Information

Updated January 16, 2023

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  • ACTIVE INGREDIENT

  • PURPOSE

  • WARNINGS

  • INDICATIONS & USAGE

  • INACTIVE INGREDIENT

  • label

    label

  • INGREDIENTS AND APPEARANCE
    SKINFUSE SHIELD  SPF 30
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59958-240
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION21 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 34 g  in 100 g
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1) 5 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 100 g
    PROPANEDIOL (UNII: 5965N8W85T) 5 g  in 100 g
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W) 4 g  in 100 g
    JOJOBA OIL (UNII: 724GKU717M) 8.97 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59958-240-0130 g in 1 TUBE; Type 0: Not a Combination Product11/12/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/11/2015
    Labeler - Owen Biosciences, Inc. (790003045)
    Establishment
    NameAddressID/FEIBusiness Operations
    Owen Biosciences, Inc.790003045manufacture(59958-240)