Label: SUNFORGETTABLE TOTAL PROTECTION COLOR BALM (BERRY)- zinc oxide stick

  • NDC Code(s): 68078-033-01, 68078-033-02
  • Packager: Colorescience
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Updated March 7, 2023

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  • Sunforgettable Total Protection Color Balm (Berry)

    Unit Carton Label

  • INGREDIENTS AND APPEARANCE
    SUNFORGETTABLE TOTAL PROTECTION COLOR BALM (BERRY) 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68078-033
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE125 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    DIMETHYLMETHOXY CHROMANOL (UNII: XBH432G01F)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SQUALANE (UNII: GW89575KF9)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    C18-36 ACID TRIGLYCERIDE (UNII: ZRA72DR3R7)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68078-033-021 in 1 CARTON02/01/2020
    1NDC:68078-033-019 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2020
    Labeler - Colorescience (128731929)
    Registrant - Nanophase Technologies Corporation (623502044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation050383046api manufacture(68078-033)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation623502044api manufacture(68078-033) , manufacture(68078-033)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nanophase Technologies Corporation118812921manufacture(68078-033) , pack(68078-033)
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