Label: MONGDIES EXCELLENT SUN CUSHION- zinc oxide, titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 70477-040-01, 70477-040-02 - 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, C12-15 Alkyl Benzoate, Caprylyl Methicone, Butyloctyl Salicylate, Glycerin, Diphenylsiloxy Phenyl Trimethicone, Ethylhexyl Palmitate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Butylene Glycol, Trimethylsiloxysilicate, Polyhydroxystearic Acid, Prunus Amygdalus Amara (Bitter Almond) Kernel Oil, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Leaf Extract, Hippophae Rhamnoides Oil, Jasminum Officinale (Jasmine) Flower Water, Vanilla Planifolia Fruit Extract, Saccharomyces/Hippophae Rhamnoides Fruit Ferment Filtrate, Hippophae Rhamnoides Fruit Oil, Glycine Max (Soybean) Seed Extract, Persea Gratissima (Avocado) Oil, Sodium Hyaluronate, Calendula Officinalis Flower Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Chamomilla Recutita (Matricaria) Flower Extract, Polyglyceryl-2 Dipolyhydroxystearate, Disteardimonium Hectorite, Magnesium Sulfate, Aluminum Hydroxide, Polymethylsilsesquioxane, Hydrogen Dimethicone, Stearic Acid, PVP, Caprylyl Glycol, Glyceryl Caprylate, Caprylic/Capric Triglyceride, Ceramide NP, Panthenol, Beta-Glucan, Tocopherol, 1,2-Hexanediol, Sodium PCA, Ethylhexylglycerin
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
MONGDIES EXCELLENT SUN CUSHION
zinc oxide, titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70477-040 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 1.38 g in 12 g Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 0.84 g in 12 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70477-040-02 1 in 1 CARTON 09/01/2021 1 NDC:70477-040-01 12 g in 1 CONTAINER; 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(70477-040)
