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.

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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

Image of carton

MONGDIES EXCELLENT SUN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70477-030
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION12.01 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Pentylene Glycol (UNII: 50C1307PZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70477-030-021 in 1 CARTON09/01/2021
1NDC:70477-030-0160 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2021
Labeler - 360Perspective Inc. (689606142)
Registrant - 360Perspective Inc. (689606142)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(70477-030)

Revised: 9/2021
Document Id: ea6056a7-36b8-4f8e-b9ab-3d2552386f5e
Set id: 0496d858-96c7-4c91-9832-648df422be25
Version: 1
Effective Time: 20210910
 
360Perspective Inc.