MONGDIES EXCELLENT SUN CUSHION- zinc oxide, 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.

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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

Image of carton

MONGDIES EXCELLENT SUN CUSHION 
zinc oxide, titanium dioxide powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70477-040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.38 g  in 12 g
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.84 g  in 12 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70477-040-021 in 1 CARTON09/01/2021
1NDC:70477-040-0112 g in 1 CONTAINER; 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(70477-040)

Revised: 9/2021
Document Id: 7f3d8d83-1d1c-434b-a520-73a3303e3a73
Set id: f3fe83a2-e38e-430f-807e-9f152ee9a102
Version: 1
Effective Time: 20210910
 
360Perspective Inc.