FDA.reportPublic FDA data

SKIN LIGHTENING COMPLEX

Manufacturer
G.S. COSMECEUTICAL USA, INC.
Effective date
2010-09-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:49

Label at a glance#

ProductSKIN LIGHTENING COMPLEX
Active ingredientHYDROQUINONE
Label structure10 sections

Dosage and administration

Apply a thin coat to the affected area twice daily or as directed by your physician Utilize sunscreen daily

Storage and handling

Read directions and warnings before use Store at room temperature 68°-77° F (20°-25° C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Hydroquinone (2.0%)

Purpose

OTC - PURPOSE SECTION

skin lightener

Indications

INDICATIONS & USAGE SECTION

  • reduce dark blotches and spots
  • even out skin tone and reduce skin discoloration

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

Avoid eye contact

OTC - STOP USE SECTION

Discontinue use if irritation occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply a thin coat to the affected area twice daily or as directed by your physician
  • Utilize sunscreen daily

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Glycolic Acid, Caprylic/Capric Triglyceride, Glycerin, Cetyl Alcohol, Stearyl Alcohol, C12-C15 Alkyl Benzoate, Hydroxypropyl Starch Phosphate, Dimethicone, Sodium Hydroxide, Myristyl Alcohol, Glyceryl Stearate, Butyl Octyl Salicylate, Myristyl Glucoside, PEG 100 Stearate, Lactic Acid, Dehydroxanthan Gum, Sodium Metabisulfite, Camellia Oleifera Leaf Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Propylene Glycol, Phenoxy ethanol, Glycyrrhiza Glabra (Licorice) Root Extract, Arctostaphylos Uva Ursi Leaf Extract, Tocopheryl Acetate, BHT, Diazolidinyl Urea, Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Disodium EDTA.

Other Information

STORAGE AND HANDLING SECTION

  • Read directions and warnings before use
  • Store at room temperature 68°-77° F (20°-25° C)

SPL UNCLASSIFIED SECTION

Distributed by:
A&D Pharma LLC

PRINCIPAL DISPLAY PANEL - 30 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

A&D
pharma

Skin
Lightening
Complex
with GLYCOLIC ACID

30 g

Principal Display Panel - 30 g Tube Label
Principal Display Panel - 30 g Tube Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
85490a6b-2306-6bf2-c51b-eb63537dc2daProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65113-8401-12019-10-21C16284748780-1956f9ecf-c10b-621f-e053-dbdaa90a74adA&D pharma Skin Lightening Complex with GLYCOLIC ACID

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65113-8401-1SKIN LIGHTENING COMPLEX30 g in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65113-8401SKIN LIGHTENING COMPLEX (HYDROQUINONE) CREAM [G.S. COSMECEUTICAL USA, INC.]1Legacy NDC, 1 package rows20100915_8c0ab847-bca6-4e0a-acfe-07a8323aa41c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROQUINONEACTIVE INGREDIENTXV74C1N1AE1
PHENOLACTIVE MOIETY339NCG44TV1
Alpha-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
Arctostaphylos Uva-Ursi LeafINACTIVE INGREDIENT3M5V3D1X361
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171K1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
ButylparabenINACTIVE INGREDIENT3QPI1U3FV81
C12-15 Alkyl BenzoateINACTIVE INGREDIENTA9EJ3J61HQ1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN1
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW41
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
EthylparabenINACTIVE INGREDIENT14255EXE391
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE41
Glycolic AcidINACTIVE INGREDIENT0WT12SX38S1
Glycyrrhiza GlabraINACTIVE INGREDIENT2788Z9758H1
Green Tea LeafINACTIVE INGREDIENTW2ZU1RY8B01
IsobutylparabenINACTIVE INGREDIENT0QQJ25X58G1
Lactic AcidINACTIVE INGREDIENT33X04XA5AT1
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7U1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
Myristyl AlcoholINACTIVE INGREDIENTV42034O9PU1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Polyoxyl 100 StearateINACTIVE INGREDIENTYD01N1999R1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
Sodium MetabisulfiteINACTIVE INGREDIENT4VON5FNS3C1
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1Y1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65113-840165113-8401-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROQUINONEXV74C1N1AEACTIB
Water059QF0KO0RIACT
Glycolic Acid0WT12SX38SIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
GlycerinPDC6A3C0OXIACT
Cetyl Alcohol936JST6JCNIACT
Stearyl Alcohol2KR89I4H1YIACT
C12-15 Alkyl BenzoateA9EJ3J61HQIACT
Dimethicone92RU3N3Y1OIACT
Sodium Hydroxide55X04QC32IIACT
Myristyl AlcoholV42034O9PUIACT
Glyceryl Monostearate230OU9XXE4IACT
Polyoxyl 100 StearateYD01N1999RIACT
Lactic Acid33X04XA5ATIACT
Sodium Metabisulfite4VON5FNS3CIACT
Butylene Glycol3XUS85K0RAIACT
Green Tea LeafW2ZU1RY8B0IACT
Propylene Glycol6DC9Q167V3IACT
PhenoxyethanolHIE492ZZ3TIACT
Glycyrrhiza Glabra2788Z9758HIACT
Arctostaphylos Uva-Ursi Leaf3M5V3D1X36IACT
Alpha-Tocopherol Acetate9E8X80D2L0IACT
Butylated Hydroxytoluene1P9D0Z171KIACT
Diazolidinyl UreaH5RIZ3MPW4IACT
MethylparabenA2I8C7HI9TIACT
PropylparabenZ8IX2SC1OHIACT
Ethylparaben14255EXE39IACT
Butylparaben3QPI1U3FV8IACT
Isobutylparaben0QQJ25X58GIACT
Edetate Disodium7FLD91C86KIACT

Source Document#

Source XML · Source PDF

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 13 · 758 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ButylparabenBUTYLPARABEN3QPI1U3FV8LOTION / TOPICAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
ButylparabenBUTYLPARABEN3QPI1U3FV8TABLET, EXTENDED RELEASE / ORAL0.01 mgExact identifier — unii candidate
15 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IJELLY / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Sodium MetabisulfiteSODIUM METABISULFITE4VON5FNS3CSOLUTION / OPHTHALMIC0.2 %w/wExact identifier — unii candidate
43 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, EXTENDED RELEASE / ORAL529 mgExact identifier — unii candidate
21 equally ranked IID candidates
Sodium MetabisulfiteSODIUM METABISULFITE4VON5FNS3CSUSPENSION/ DROPS / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
43 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTERSTITIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4EMULSION / ORALNAExact identifier — unii candidate
21 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRA-AMNIOTICADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii candidate
79 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / URETHRALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IELIXIR / ORALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
174 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Butylated HydroxytolueneBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS0.02 mgExact identifier — unii candidate
32 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / TOPICAL39 mgExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KDROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii candidate
21 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
21 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KTABLET, COATED / ORAL0.21 mgExact identifier — unii candidate
77 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION / RESPIRATORY (INHALATION)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATINJECTION, SOLUTION / INTRAVENOUS87 mgExact identifier — unii candidate
18 equally ranked IID candidates
Medium-Chain TriglyceridesMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UPOWDER / SUBLINGUAL2 mgExact identifier — unii candidate
18 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISUSPENSION / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAPERITONEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAUDALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RESPIRATORY (INHALATION)0.03 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium MetabisulfiteSODIUM METABISULFITE4VON5FNS3CSYSTEM / IONTOPHORESIS0.5 mgExact identifier — unii candidate
43 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
68 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHEMULSION / TOPICAL0.06 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Sodium MetabisulfiteSODIUM METABISULFITE4VON5FNS3CINJECTION, SOLUTION / INFILTRATION0.05 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNSUSPENSION / AURICULAR (OTIC)1 %w/vExact identifier — unii candidate
20 equally ranked IID candidates
Lactic AcidLACTIC ACID33X04XA5ATINJECTION / INTRAVENOUS2232 mgExact identifier — unii candidate
18 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
747d192d-0a31-44b3-8dff-71cb2aa196ea8c0ab847-bca6-4e0a-acfe-07a8323aa41c2010-09-02WarningsExact identifier
spl id: 747d192d-0a31-44b3-8dff-71cb2aa196ea
spl set id: 8c0ab847-bca6-4e0a-acfe-07a8323aa41c

Reported adverse events (FAERS/openFDA)#

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