Label: CIELE GLOW AND PROTECT- zinc oxide lotion

  • NDC Code(s): 83103-2344-1, 83103-2344-2
  • Packager: Ciele Cosmetics
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 18, 2024

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  • Ciele Glow and Protect

    Dosage and Administration

  • Ciele Glow and Protect

    Inactive ingredients

  • Ciele Glow and Protect

    Indications & usage

  • Ciele Glow and Protect

    Active Ingredients

  • Ciele Glow and Protect

    keep out of reach of children

  • Ciele Glow and Protect

    purpose

  • Ciele Glow and Protect

    Warning Label

  • Ciele Glow and Protect

    PDP

  • INGREDIENTS AND APPEARANCE
    CIELE GLOW AND PROTECT 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83103-2344
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE88 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)  
    .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)  
    WATER (UNII: 059QF0KO0R)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    LAURYL PEG-8 DIMETHICONE (300 CPS) (UNII: ELL2U7K8T8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CAPRYLYL METHICONE (UNII: Q95M2P1KJL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    TIN OXIDE (UNII: KM7N50LOS6)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83103-2344-21 in 1 CARTON11/01/2024
    1NDC:83103-2344-15.5 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/2024
    Labeler - Ciele Cosmetics (105041170)
    Registrant - Nanophase Technologies Corporation (623502044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation050383046api manufacture(83103-2344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation118812921manufacture(83103-2344) , pack(83103-2344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation623502044api manufacture(83103-2344) , manufacture(83103-2344)
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