Label: MONGDIES EXCELLENT SUN- zinc oxide cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70477-030-01, 70477-030-02 - Packager: 360Perspective Inc.
- 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
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
- Uses
- Directions
- Other Information
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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
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INGREDIENTS AND APPEARANCE
MONGDIES EXCELLENT SUN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70477-030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 12.01 g in 60 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Pentylene Glycol (UNII: 50C1307PZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70477-030-02 1 in 1 CARTON 09/01/2021 1 NDC:70477-030-01 60 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 09/01/2021 Labeler - 360Perspective Inc. (689606142) Registrant - 360Perspective Inc. (689606142) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(70477-030)