Mongdies Excellent Sun: Package Insert and Label Information

MONGDIES EXCELLENT SUN- zinc oxide cream
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 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

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MONGDIES EXCELLENT SUN
zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:70477-030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Zinc Oxide (ZINC CATION) ZINC CATION 12.01 g in 60 mL
Inactive Ingredients
Ingredient Name Strength
Water
Glycerin
Pentylene Glycol
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70477-030-02 1 TUBE in 1 CARTON contains a TUBE (70477-030-01)
1 NDC:70477-030-01 60 mL in 1 TUBE This package is contained within the CARTON (70477-030-02)
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 (70477-030)

Revised: 09/2021 360Perspective Inc.

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