MONGDIES EXCELLENT SUN CUSHION- zinc oxide, titanium dioxide powder

Mongdies excellent sun cushion by

Drug Labeling and Warnings

Mongdies excellent sun cushion by is a Otc medication manufactured, distributed, or labeled by 360Perspective Inc., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 11.52%
Titanium Dioxide 7.03%

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. Avoid direct sunlight.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

Uses

An inorganic hypoallergenic cushion type sun screen with moisturizing and skin protection effects.

Directions

Evenly apply to areas when sun protection is required.

Other Information

Avoid direct sunlight.

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

INGREDIENTS AND APPEARANCE

MONGDIES EXCELLENT SUN CUSHION 
zinc oxide, titanium dioxide powder

Product 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)