FDA.reportPublic FDA data

Essential Fade Complex

Manufacturer
Biocosmetics Research Lab
Effective date
2011-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:00

Label at a glance#

ProductEssential Fade Complex
Active ingredientHydroquinone
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Hydroquinone 2%

OTC - PURPOSE SECTION

Purpose

Skin Lightener Gel

INDICATIONS & USAGE SECTION

Use For gradual fading of dark (brownish) spots.

WARNINGS SECTION

Warnings

Avoid contact with eyes. Children under 12 years of age: do not use unless directed by a doctor. Some users may experience a mild irritation. If skin irritation becomes severe, stop use and consult a doctor.

DOSAGE & ADMINISTRATION SECTION

Directions Apply a small amount as a thin layer on the affected area or use as directed by a doctor. Sun exposure should be limited by using a sunscreen agent, a sun blocking agent or protective clothing in order to prevent darkening from reoccurring.

INACTIVE INGREDIENT SECTION

Other Ingredients

Water, Propylene Glycol, Cyclomethicone, Dimethiconol, Soybean (Glycine Soja) Oil, Ethylhexyl Cocoate, Butylene Glycol, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Dimethicone, Citrus Unshiu Peel Extract, Lecithin, Retinol, Glycolipids, Glycerin, Hydroxyethylcellulose, EDTA, Sodium Metabisulfite, Sodium Sulfite, Phenoxyethanol, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Fragrance, Yellow 5,  Green 5.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of efadecimage of efadec

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199176hydroquinone 2 % Topical GelPSN1
199176hydroquinone 0.02 MG/MG Topical GelSCD1
199176hydroquinone 2 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROQUINONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59735-318-152020-01-31C16284748780-19d75b9d0-2080-f424-e053-dadaa90a57ceEssential Fade Complex

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59735-318-15Essential Fade Complex1 in 1 CARTONGEL11
59735-318-15Essential Fade Complex15 g in 1 TUBEGEL151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59735-318ESSENTIAL FADE COMPLEX (HYDROQUINONE GEL) GEL [BIOCOSMETICS RESEARCH LAB]1Legacy NDC, 2 package rows20110121_8ea20704-026a-40da-9e33-0ba9ed897744.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HydroquinoneACTIVE INGREDIENTXV74C1N1AE1
HydroquinoneACTIVE MOIETYXV74C1N1AE1
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
59735-31859735-318-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HydroquinoneXV74C1N1AEACTIB
Water059QF0KO0RIACT

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
caf1f5b5-8bef-471c-9775-773a7e5ade718ea20704-026a-40da-9e33-0ba9ed8977442011-01-20WarningsExact identifier
spl id: caf1f5b5-8bef-471c-9775-773a7e5ade71
spl set id: 8ea20704-026a-40da-9e33-0ba9ed897744

Reported adverse events (FAERS/openFDA)#

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