MONGDIES EXCELLENT SUN- zinc oxide cream

Mongdies excellent sun by

Drug Labeling and Warnings

Mongdies excellent sun 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 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

INGREDIENTS AND APPEARANCE

MONGDIES EXCELLENT SUN 
zinc oxide cream

Product 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)