Mongdies Excellent Sun Cushion: Package Insert and Label Information

MONGDIES EXCELLENT SUN CUSHION- zinc oxide and titanium dioxide powder
360Perspective Inc.

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.

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide (ZINC CATION) ZINC CATION 1.38 g in 12 g
Titanium Dioxide (TITANIUM DIOXIDE) Titanium Dioxide 0.84 g in 12 g
Inactive Ingredients
Ingredient Name Strength
Water
ALKYL (C12-15) BENZOATE
CAPRYLYL TRISILOXANE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70477-040-02 1 CONTAINER in 1 CARTON contains a CONTAINER (70477-040-01)
1 NDC:70477-040-01 12 g in 1 CONTAINER This package is contained within the CARTON (70477-040-02)
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 Operations
Cosmax, Inc. 689049693 manufacture (70477-040)

Revised: 09/2021 360Perspective Inc.

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