FDA.reportPublic FDA data

VITAMIN B5 ESSENCE

Manufacturer
NATURE REPUBLIC CO., LTD. | Cosmax, Inc
Effective date
2017-01-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:34

Label at a glance#

ProductVITAMIN B5 ESSENCE
Active ingredientDimethicone
Label structure8 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: Dimethicone 4.50%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive ingredients: Water, Cyclopentasiloxane, Glycerin, Panthenol, Niacinamide, Pentylene Glycol, Polyglycerin-3, Trehalose, Dipropylene Glycol, Xylitol, Sodium Polyacrylate, Butylene Glycol, Propanediol, Boron Nitride, Phenoxyethanol, PEG/PPG-18/18 Dimethicone, Pyrus Malus (Apple) Fruit Water, Lecithin, Ethylhexyl Stearate, Sodium Hyaluronate, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Disodium EDTA, Trideceth-6, Madecassoside, Polyglutamic Acid

PURPOSE

OTC - PURPOSE SECTION

Purpose: Skin Protectant

WARNINGS

WARNINGS SECTION

Warnings: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of irritation or rashes 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 & USAGE

INDICATIONS & USAGE SECTION

Indications & Usage: The vitamin B5 essence helps sensitive and dry skin feel moisturized.

DOSAGE & ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dosage & Administration: After using toner, apply an appropriate amount on the entire face and gently pat to promote absorption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359450dimethicone 4.5 % Topical CreamPSN1
359450dimethicone 45 MG/ML Topical CreamSCD1
359450dimethicone 4.5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51346-436-022021-01-29C16284748780-1ba0f9c33-0d87-a910-e053-dadaa90a0b85c0d0a5cc-2f1a-4d70-aee4-80099a28107a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51346-436-01VITAMIN B5 ESSENCE35 mL in 1 BOTTLE, PUMPCREAM351
51346-436-02VITAMIN B5 ESSENCE1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51346-436VITAMIN B5 ESSENCE (DIMETHICONE) CREAM [NATURE REPUBLIC CO., LTD.]1Legacy NDC, 2 package rows20170119_c0d0a5cc-2f1a-4d70-aee4-80099a28107a.zip

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
51346-43651346-436-01, 51346-436-02

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
Dimethicone92RU3N3Y1OACTIB
Water059QF0KO0RIACT
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
f1c6ae79-6927-42bc-a2ab-e7e025796aedc0d0a5cc-2f1a-4d70-aee4-80099a28107a2017-01-19WarningsExact identifier
spl id: f1c6ae79-6927-42bc-a2ab-e7e025796aed
spl set id: c0d0a5cc-2f1a-4d70-aee4-80099a28107a

Reported adverse events (FAERS/openFDA)#

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