Label: MONGDIES EXCELLENT SUN- zinc oxide cream

  • 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 September 10, 2021

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  • ACTIVE INGREDIENT

    Zinc Oxide 20.02%

  • PURPOSE

    Sunscreen

  • WARNINGS

    For external use only. If skin irritation occurs or increases, discontinue use and consult a physician. Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Uses

    An inorganic sun cream with no irritation that contains plant extracts to provide moisturizing and soothing effects.

  • Directions

    Evenly apply to areas when sun protection is required.

  • Other Information

    Avoid direct sunlight.

  • INACTIVE INGREDIENTS

    Water, Coco-Caprylate/Caprate, Propanediol, Glycerin, Pentylene Glycol, Polyhydroxystearic Acid, Prunus Amygdalus Amara (Bitter Almond) Kernel Oil, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Leaf Extract, Jasminum Officinale (Jasmine) Flower Water, Vanilla Planifolia Fruit Extract, Water, Anthemis Nobilis Flower Extract, Eucalyptus Globulus Leaf Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Origanum Majorana Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Origanum Vulgare Leaf Extract, Beheneth-25, Methyl Methacrylate Crosspolymer, Silica, Triethoxycaprylylsilane, Cetearyl Olivate, Sorbitan Olivate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Caprylyl Glycol, Polyacrylate Crosspolymer-6, Trisodium Ethylenediamine Disuccinate, Madecassoside, Asiaticoside, Asiatic Acid, Madecassic Acid, Butylene Glycol, 1,2-Hexanediol, Xanthan Gum

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MONGDIES EXCELLENT SUN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70477-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12.01 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70477-030-021 in 1 CARTON09/01/2021
    1NDC:70477-030-0160 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/01/2021
    Labeler - 360Perspective Inc. (689606142)
    Registrant - 360Perspective Inc. (689606142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc.689049693manufacture(70477-030)
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