FDA.reportPublic FDA data

SUPER AQUA MAX WHITE C LUMINOUS AMPOULE

Manufacturer
NATURE REPUBLIC CO., LTD.
Effective date
2012-09-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:45:44

Label at a glance#

ProductSUPER AQUA MAX WHITE C LUMINOUS AMPOULE
Active ingredientDIMETHICONE
Label structure8 sections

Indications and uses

How to Use: Apply an appropriate amount to your entire face. Then gently pat your face to enhance its absorption into your skin.

Dosage and administration

How to Use: Apply an appropriate amount to your entire face. Then gently pat your face to enhance its absorption into your skin.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: DIMETHICONE 4.5%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION


Inactive Ingredients:
Myrciaria Dubia Fruit Extract, Phenoxyethanol, Dipropylene Glycol, Caprylyl Methicone, Maltitol, Niacinamide, Betaine, Isononyl Isononanoate, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Titanium Dioxide, Mica, Silica, PEG-60 Hydrogenated Castor Oil, PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin, Fragrance(Parfum), PEG-11 Methyl Ether Dimethicone, Caprylyl Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Caprylate, Dipotassium Glycyrrhizate, Triethanolamine, Tocopheryl Acetate, Polyvinyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Water, Glycerin, Butylene Glycol, Sodium Polyacrylate, Hedera Helix (Ivy) Leaf/Stem Extract, Phytic Acid, PEG-8, PPG-1-PEG-9 Lauryl Glycol Ether, Helianthus Annuus (Sunflower) Seed Extract, Trichosanthes Kirilowii Root Extract, Oenothera Biennis (Evening Primrose) Flower Extract, Ipomoea Purpurea Extract, Mirabilis Jalapa Extract, Citrus Aurantium Dulcis (Orange) Fruit Water, Avena Sativa (Oat) Kernel Extract, Rubus Idaeus (Raspberry) Leaf Extract, Calendula Officinalis Flower Extract, Nepeta Cataria Extract, Stellaria Media (Chickweed) Extract, Baptisia Tinctoria Root Extract, Ascorbyl Glucoside

PURPOSE

OTC - PURPOSE SECTION

Purpose: Refreshing, moisturizing, and radiant brigtening ampoule.

WARNINGS

WARNINGS SECTION

Cautions:
For external use only.
Avoid contact with eyes and mouth.
Discontinue use if signs of irritation or rash appear.
Keep out of reach of children.
Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

How to Use: Apply an appropriate amount to your entire face. Then gently pat your face to enhance its absorption into your skin.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

How to Use: Apply an appropriate amount to your entire face. Then gently pat your face to enhance its absorption into your skin.

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-138809344263834GTIN-13: 8809344263834
EAN-13: 8809344263834
GTIN storage (14 digits): 08809344263834		super aqua max white c luminous ampoule carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51346-130-012021-06-30C16284748780-19d75b9d0-03d3-f424-e053-dadaa90a57ceef162b2a-9b23-4201-bf56-50c954b1b39d
51346-130-012020-01-31C16284748780-19d75b9d0-03d3-f424-e053-dadaa90a57ceef162b2a-9b23-4201-bf56-50c954b1b39d

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1O1
DIMETHICONEACTIVE MOIETY92RU3N3Y1O1
BetaineINACTIVE INGREDIENT3SCV180C9W1
Dipropylene GlycolINACTIVE INGREDIENTE107L85C401
MaltitolINACTIVE INGREDIENTD65DG142WK1
NiacinamideINACTIVE INGREDIENT25X51I8RD41
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51346-13051346-130-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIM
PhenoxyethanolHIE492ZZ3TIACT
Dipropylene GlycolE107L85C40IACT
MaltitolD65DG142WKIACT
Niacinamide25X51I8RD4IACT
Betaine3SCV180C9WIACT

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 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MaltitolMALTITOLD65DG142WKSUSPENSION / ORAL39600 mg/120mlExact identifier — unii candidate
7 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
MaltitolMALTITOLD65DG142WKFILM / SUBLINGUAL24 mgExact identifier — unii candidate
7 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
Dipropylene GlycolDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
MaltitolMALTITOLD65DG142WKCAPSULE / ORAL155 mgExact identifier — unii candidate
7 equally ranked IID candidates
MaltitolMALTITOLD65DG142WKFILM, SOLUBLE / ORAL44 mgExact identifier — unii candidate
7 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
MaltitolMALTITOLD65DG142WKSOLUTION / ORAL9000 mgExact identifier — unii candidate
7 equally ranked IID candidates
Dipropylene GlycolDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
NiacinamideNIACINAMIDE25X51I8RD4INJECTION / INTRAVENOUS2.5 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
NiacinamideNIACINAMIDE25X51I8RD4GEL / TOPICAL25 mgExact identifier — unii candidate
4 equally ranked IID candidates
MaltitolMALTITOLD65DG142WKTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
7 equally ranked IID candidates
MaltitolMALTITOLD65DG142WKGUM, CHEWING / BUCCAL4932 mgExact identifier — unii candidate
7 equally ranked IID candidates
NiacinamideNIACINAMIDE25X51I8RD4INJECTION / INTRAMUSCULAR2.5 %w/vExact identifier — unii candidate
4 equally ranked IID candidates
NiacinamideNIACINAMIDE25X51I8RD4CREAM / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
Dipropylene GlycolDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 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
9db96c17-f2d3-41b3-b7db-c833154681cbef162b2a-9b23-4201-bf56-50c954b1b39d2021-06-29WarningsExact identifier
spl set id: ef162b2a-9b23-4201-bf56-50c954b1b39d

Reported adverse events (FAERS/openFDA)#

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