FDA.reportPublic FDA data

Mongdies excellent sun cushion

Manufacturer
360Perspective Inc. | Cosmax, Inc.
Effective date
2021-09-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:42:21

Label at a glance#

ProductMongdies excellent sun cushion
Active ingredientZinc Oxide, Titanium Dioxide
Label structure9 sections

Indications and uses

An inorganic hypoallergenic cushion type sun screen with moisturizing and skin protection effects.

Dosage and administration

Evenly apply to areas when sun protection is required.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 11.52%
Titanium Dioxide 7.03%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Uses

INDICATIONS & USAGE SECTION

An inorganic hypoallergenic cushion type sun screen with moisturizing and skin protection effects.

Directions

DOSAGE & ADMINISTRATION SECTION

Evenly apply to areas when sun protection is required.

Other Information

OTHER SAFETY INFORMATION

Avoid direct sunlight.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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 cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70477-040-022024-01-30C16284748780-11030e365-47c1-111a-e063-dadaa90a10e2f3fe83a2-e38e-430f-807e-9f152ee9a102

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70477-040-01Mongdies excellent sun cushion12 g in 1 CONTAINERPOWDER121
70477-040-02Mongdies excellent sun cushion1 in 1 CARTONPOWDER11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70477-040MONGDIES EXCELLENT SUN CUSHION (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [360PERSPECTIVE INC.]1Legacy NDC, 2 package rows20210911_f3fe83a2-e38e-430f-807e-9f152ee9a102.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70477-04070477-040-01, 70477-040-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIM
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
7f3d8d83-1d1c-434b-a520-73a3303e3a73f3fe83a2-e38e-430f-807e-9f152ee9a1022021-09-10WarningsExact identifier
spl id: 7f3d8d83-1d1c-434b-a520-73a3303e3a73
spl set id: f3fe83a2-e38e-430f-807e-9f152ee9a102

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.