ZEBS BROAD SPECTRUM SUNSCREEN (ZINC OXIDE) LOTION [NEW ERA NATURALS LLC]

ZEBS BROAD SPECTRUM SUNSCREEN (ZINC OXIDE) LOTION [NEW ERA NATURALS LLC]
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NDC 70397-2016-1, 70397-2016-2
Set ID 289542c1-1347-3b43-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager New Era Naturals LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • see label

    label

  • INACTIVE INGREDIENT

    inactive ingredients

  • INSTRUCTIONS FOR USE

    instructions for use

  • ACTIVE INGREDIENT

    active ingredient

  • WHEN USING

    when using

  • PRINCIPAL DISPLAY PANEL

    Zebs display panel

  • INGREDIENTS AND APPEARANCE
    ZEBS BROAD SPECTRUM SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70397-2016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE8 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI) 33 g  in 100 g
    COCONUT OIL (UNII: Q9L0O73W7L) 24 g  in 100 g
    WHITE WAX (UNII: 7G1J5DA97F) 14 g  in 100 g
    OLIVE OIL (UNII: 6UYK2W1W1E) 11 g  in 100 g
    SHEA BUTTER (UNII: K49155WL9Y) 10 g  in 100 g
    Product Characteristics
    Colorwhite (lotion) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70397-2016-188.4 g in 1 TUBE; Type 0: Not a Combination Product02/15/2016
    2NDC:70397-2016-2208 g in 1 TUBE; Type 0: Not a Combination Product02/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/08/2016
    Labeler - New Era Naturals LLC (080099019)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Era Naturals LLC080099019manufacture(70397-2016) , pack(70397-2016) , label(70397-2016)

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