Label: ZEBS ORGANICS SUNSCREEN- zinc oxide lotion

  • 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.

Drug Label Information

Updated October 24, 2016

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  • ACTIVE INGREDIENT

  • INACTIVE INGREDIENT

  • INSTRUCTIONS FOR USE

  • WHEN USING

  • WARNINGS

  • WARNINGS AND PRECAUTIONS

  • PRINCIPAL DISPLAY PANEL

    Zebs SPF 30 tube

  • INGREDIENTS AND APPEARANCE
    ZEBS ORGANICS SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70397-2017
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11 g  in 90 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L) 22 g  in 90 g
    WHITE WAX (UNII: 7G1J5DA97F) 10 g  in 90 g
    SHEA BUTTER (UNII: K49155WL9Y) 10 g  in 90 g
    SUNFLOWER OIL (UNII: 3W1JG795YI) 32 g  in 90 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70397-2017-188.4 g in 1 TUBE; Type 0: Not a Combination Product07/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2018
    Labeler - New Era Naturals LLC (080099019)
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