GP SUNSCREEN (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [CROSS-BRANDS MANUFACTURING, LLC]

GP SUNSCREEN (AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE) LOTION [CROSS-BRANDS MANUFACTURING, LLC]
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NDC 71153-2000-1
Set ID 444a04b9-c142-2c14-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Cross-Brands Manufacturing, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • PRINCIPAL DISPLAY PANEL

    Front Label

  • INGREDIENTS AND APPEARANCE
    GP SUNSCREEN 
    avobenzone,homosalate,octisalate,octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71153-2000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71153-2000-1237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/23/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/23/2016
    Labeler - Cross-Brands Manufacturing, LLC (080319350)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cross-Brands Manufacturing, LLC080319350manufacture(71153-2000) , label(71153-2000)

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