FDA.reportPublic FDA data

3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION SOFT BEIGE

Manufacturer
NANDA CO., LTD. | COSMAX INC.
Effective date
2013-10-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:37:07

Label at a glance#

Product3 CONCEPT EYES GLOSSING WATERFUL FOUNDATION SOFT BEIGE
Active ingredientTitanium Dioxide
Label structure8 sections

Indications and uses

Indication and usage 1. Always close the lid after use.2. Keep this product in the room temperature.

Dosage and administration

Dosage and administration Shake foundation enough to be mixed before use, and apply suitable amount of it on your face evenly with a foundation brush.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Titanium Dioxide 3.615%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Cyclopentasiloxane, Diphenylsiloxy Phenyl Trimethicone, Cyclohexasiloxane, Butylene Glycol, Ethylhexyl Methoxycinnamate, Butylene Glycol Dicaprylate/Dicaprate, PEG-10 Dimethicone, Zinc Oxide (CI 77947), Glycerin , Trimethylsiloxysilicate, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Mica (CI 77019), Sodium Chloride, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Acrylates/Stearyl Acrylate/Dimethicone Methacrylate Copolymer, Cyclomethicone, Iron Oxides (CI 77492), Disteardimonium Hectorite, Sorbitan Isostearate, Tribehenin, HDI/Trimethylol Hexyllactone Crosspolymer, Phenyl Trimethicone, Phenoxyethanol, Iron Oxides (CI 77491), Dimethicone Crosspolymer, Triethoxycaprylylsilane,Glyceryl Behenate, Polyglyceryl-6 Octastearate, Dimethicone, Disodium EDTA, Iron Oxides (CI 77499), Ethylhexylglycerin,Silica

PURPOSE

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS

WARNINGS SECTION

Warnings Keep out of eyes. Stop use if irritation occurs. Keep out of reach of babies and children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of babies and children.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Indication and usage 1. Always close the lid after use.2. Keep this product in the room temperature.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage and administration Shake foundation enough to be mixed before use, and apply suitable amount of it on your face evenly with a foundation brush.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809348110271GTIN-13: 8809348110271
EAN-13: 8809348110271
GTIN storage (14 digits): 08809348110271		3 concept eyes glossing waterful foundation soft beige carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60764-004-012020-01-31C16284748780-19d75b9d1-0741-f424-e053-dadaa90a57ce6eaf46fd-113c-4f83-bab7-72a8d4cf741a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60764-004-013 CONCEPT EYES GLOSSING WATERFUL FOUNDATION SOFT BEIGE40 g in 1 CARTONCREAM401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60764-0043 CONCEPT EYES GLOSSING WATERFUL FOUNDATION SOFT BEIGE (TITANIUM DIOXIDE) CREAM [NANDA CO., LTD.]1Legacy NDC, 1 package rows20131003_6eaf46fd-113c-4f83-bab7-72a8d4cf741a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60764-00460764-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Water059QF0KO0RIACT
Butylene Glycol3XUS85K0RAIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
Butylene GlycolBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates

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
35a3eaa6-40d8-431c-8e4d-a2fa482e768f6eaf46fd-113c-4f83-bab7-72a8d4cf741a2013-10-03WarningsExact identifier
spl id: 35a3eaa6-40d8-431c-8e4d-a2fa482e768f
spl set id: 6eaf46fd-113c-4f83-bab7-72a8d4cf741a

Reported adverse events (FAERS/openFDA)#

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