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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  • INGREDIENTS AND APPEARANCE
    ZEBS ORGANICS SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:70397-2017
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 11 g  in 90 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:70397-2017-1 88.4 g in 1 TUBE; Type 0: Not a Combination Product 07/01/2018
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 07/01/2018
    Labeler - New Era Naturals LLC (080099019)
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