FDA.reportPublic FDA data

COSMEPURE BRIGHTENING CALMING TONER

Manufacturer
Cosmogen Co., Ltd.
Effective date
2021-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:43

Label at a glance#

ProductCOSMEPURE BRIGHTENING CALMING TONER
Active ingredientNiacinamide
Label structure10 sections

Indications and uses

■ Helps improve trouble relax and good for sensitive skin

Dosage and administration

■ Apply an appropriate amount evenly on the skin.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Niacinamide 2.0%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Polygonum Multiflorum Root Extract, Glycerin, Betaine, Butylene Glycol, 1,2-Hexanediol, Hyaluronic Acid, Calendula Officinalis Flower Extract, Aloe Barbadensis Leaf Extract, Salicornia Herbacea Extract, Salix Nigra (Willow) Bark Extract, Lavandula Angustifolia (Lavender) Flower Water, Houttuynia Cordata Extract, allantoin, PEG-60 Hydrogenated castor oil, Carbomer, Disodium EDTA, Potassium hydroxide, Fragrance

PURPOSE

OTC - PURPOSE SECTION

Skin brightening

WARNINGS

WARNINGS SECTION

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

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

■ Helps improve trouble relax and good for sensitive skin

Directions

DOSAGE & ADMINISTRATION SECTION

■ Apply an appropriate amount evenly on the skin.

Other information

OTHER SAFETY INFORMATION

■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81418-080-022024-01-30C16284748780-11030e365-0091-111a-e063-dadaa90a10e2b5384ce6-5dfd-4bc4-8967-ad92cf0b5fe0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81418-080-01COSMEPURE BRIGHTENING CALMING TONER130 mL in 1 BOTTLELIQUID1301
81418-080-02COSMEPURE BRIGHTENING CALMING TONER1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81418-080COSMEPURE BRIGHTENING CALMING TONER (NIACINAMIDE) LIQUID [COSMOGEN CO., LTD.]1Legacy NDC, 2 package rows20210305_b5384ce6-5dfd-4bc4-8967-ad92cf0b5fe0.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81418-08081418-080-01, 81418-080-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Niacinamide25X51I8RD4ACTIB
Water059QF0KO0RIACT
REYNOUTRIA MULTIFLORA ROOTAUZ3VD75MCIACT
GlycerinPDC6A3C0OXIACT

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
90c01105-ba96-43c8-9fb6-bf5bd963f19cb5384ce6-5dfd-4bc4-8967-ad92cf0b5fe02021-03-04WarningsExact identifier
spl id: 90c01105-ba96-43c8-9fb6-bf5bd963f19c
spl set id: b5384ce6-5dfd-4bc4-8967-ad92cf0b5fe0

Reported adverse events (FAERS/openFDA)#

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