FDA.reportPublic FDA data

Dark Spot Corrector

Manufacturer
LANGE SAS
Effective date
2012-07-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:34:29

Label at a glance#

ProductDark Spot Corrector
Active ingredientPOLYETHYLENE GLYCOL 400
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Key Active Ingredients Seaweed, Licorice Root  Pearl Protein Extracts

OTC - PURPOSE SECTION

Dark Spot Corrector Lange
A remarquable formula highly concentrated in whitening actives for an intensive treatment through local applications on dark spots. Its efficient corrective functions on pigment irregularities will help to:
  • Eliminate melanin synthesis at all levels on Dark Sports,
  • Actively prevent the appearance of new dark spots,
  • Create a more even appearance.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children.

INDICATIONS & USAGE SECTION

This Whitening Seaweed inhibits melanine synthesis and reduces pigmentation of synthesized melanins with elimination of pigmented scales.

WARNINGS SECTION

WARNING!
Avoid contact with the eyes; avoid or afford protecting UV whilst using products containing AHA because of the suggestion of susceptibility to increased damage from UV.

DOSAGE & ADMINISTRATION SECTION

15ML. 051 FL OZ.

INACTIVE INGREDIENT SECTION

WATER, PEG-8, POLYSORBATE 20, MANNITOL, CHONDRUS CRISPUS (CARRAGEENAN) PLANTS AND PLANT EXTRACTS, PROPYLENE GLYCOL, GLYCERIN DENATURANT, PHENOXYETHANOL, BENZOPHENONE-4, SODIUM METHYLPARABEN, BENZYL ALCOHOL PRESERVATIVE, SODIUM PCA, AMMONIUM ACRYLOYLDIMETHYLTAURATE, DISODIUM EDTA CHELATING, SODIUM GLUCONATE CHELATING, MAGNESIUM ASCORBYL PHOSPHATE, CITRIC ACID, SODIUM CITRATE, CITRUS NOBILIS (MANDARIN ORANGE) FRUIT EXTRACT, ASCOPHYLLUM NODOSUM EXTRACT, SODIUM PROPYLPARABEN, BUTYLENE GLYCOL HUMECTANT, WALTHERIA INDICA LEAF EXTRACT,TITANIUM DIOXIDE, BAMBUSA VULGARIS LEAF, DEXTRIN ABSORBENT, FERULIC ACID, METHYLPARABEN PRESERVATIVE, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, MALIC ACID, PROPYLPARABEN, HYDROLYZED CONCHIOLIN PROTEIN, TARTARIC ACID, FREESIA ALBA FLOWER EXTRACT, GARDENIA TAHITENSIS FLOWER EXTRACT, HIBISCUS SABDARIFFA FLOWER EXTRACT, LILIUM CANDIDUM FLOWER EXTRACT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label
label
LANGE PARIS
Dark Spot Corrector
Concentrate with Seaweed extract and whitening complex

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51830-023-032019-11-27C16284748780-19855d018-dd21-cd31-e053-dbdaa90ab51a85b08f4a-d25a-4786-b700-54dca45095ad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51830-023-03Dark Spot Corrector15 mg in 1 TUBECREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51830-023DARK SPOT CORRECTOR (POLYETHYLENE GLYCOL 400) CREAM [LANGE SAS]2Legacy NDC, 1 package rows20130213_85b08f4a-d25a-4786-b700-54dca45095ad.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
POLYETHYLENE GLYCOL 400ACTIVE INGREDIENTB697894SGQ2
POLYETHYLENE GLYCOL 400ACTIVE MOIETYB697894SGQ2
AMMONIUM ACRYLOYLDIMETHYLTAURATEINACTIVE INGREDIENTKBC00G95HI2
ASCOPHYLLUM NODOSUMINACTIVE INGREDIENT168S4EO8YJ2
BAMBUSA VULGARIS LEAFINACTIVE INGREDIENTEMY54R518C2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
CHONDRUS CRISPUSINACTIVE INGREDIENTOQS23HUA1X2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
FERULIC ACIDINACTIVE INGREDIENTAVM951ZWST2
FREESIA ALBA FLOWERINACTIVE INGREDIENT33X293N6JT2
GARDENIA TAITENSIS FLOWERINACTIVE INGREDIENTT0OCU8201Y2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H2
HIBISCUS SABDARIFFA FLOWERINACTIVE INGREDIENT45TGG6IU6M2
ICODEXTRININACTIVE INGREDIENT2NX48Z0A9G2
LILIUM CANDIDUM FLOWERINACTIVE INGREDIENTCOV655U2CJ2
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M52
MALIC ACIDINACTIVE INGREDIENT817L1N4CKP2
MANNITOLINACTIVE INGREDIENT3OWL53L36A2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHK2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
PROPYLPARABEN SODIUMINACTIVE INGREDIENT625NNB0G9N2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
SODIUM GLUCONATEINACTIVE INGREDIENTR6Q3791S762
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A22
SULISOBENZONEINACTIVE INGREDIENT1W6L629B4K2
TANGERINEINACTIVE INGREDIENTKH3E3096OO2
TARTARIC ACIDINACTIVE INGREDIENTW4888I119H2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
WALTHERIA INDICA LEAFINACTIVE INGREDIENTT69OLD66172
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51830-02351830-023-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 400B697894SGQACTIB
WATER059QF0KO0RIACT
ASCOPHYLLUM NODOSUM168S4EO8YJIACT
POLYSORBATE 207T1F30V5YHIACT
MANNITOL3OWL53L36AIACT
CHONDRUS CRISPUSOQS23HUA1XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SULISOBENZONE1W6L629B4KIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATEKBC00G95HIIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM GLUCONATER6Q3791S76IACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM CITRATE1Q73Q2JULRIACT
TANGERINEKH3E3096OOIACT
ASCOPHYLLUM NODOSUM168S4EO8YJIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
WALTHERIA INDICA LEAFT69OLD6617IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BAMBUSA VULGARIS LEAFEMY54R518CIACT
ICODEXTRIN2NX48Z0A9GIACT
FERULIC ACIDAVM951ZWSTIACT
METHYLPARABENA2I8C7HI9TIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
MALIC ACID817L1N4CKPIACT
PROPYLPARABENZ8IX2SC1OHIACT
TARTARIC ACIDW4888I119HIACT
FREESIA ALBA FLOWER33X293N6JTIACT
GARDENIA TAITENSIS FLOWERT0OCU8201YIACT
HIBISCUS SABDARIFFA FLOWER45TGG6IU6MIACT
LILIUM CANDIDUM FLOWERCOV655U2CJIACT

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 12 · 712 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKSUSPENSION / ORAL80 mgExact identifier — unii candidate
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
ICODEXTRINICODEXTRIN2NX48Z0A9GTABLET, COATED / ORAL10 mgExact identifier — unii candidate
7 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / RESPIRATORY (INHALATION)8 mgExact identifier — unii candidate
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / SUBCUTANEOUS0.95 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM GLUCONATESODIUM GLUCONATER6Q3791S76SOLUTION / ORAL2.5 mg/1mlExact identifier — unii candidate
3 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET, FILM COATED / ORAL2309 mgExact identifier — unii candidate
65 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HPELLET / ORAL354 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR144 mgExact identifier — unii candidate
50 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR11 mgExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36AINJECTION / INTRAVENOUS15200 mgExact identifier — unii candidate
65 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION/ DROPS / OPHTHALMIC0.01 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS144 mgExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKPOWDER, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36APOWDER, FOR SOLUTION / ORAL3767 mgExact identifier — unii candidate
65 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSOLUTION / INTRAVENOUS242 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHLIQUID / INTRAVENOUS1.04 %w/vExact identifier — unii candidate
50 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKTABLET / ORAL0.19 mgExact identifier — unii candidate
6 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHOINTMENT / TOPICAL2.2 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDOUCHE / VAGINAL0.07 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
28 equally ranked IID candidates
MANNITOLMANNITOL3OWL53L36ATABLET / BUCCAL360 mgExact identifier — unii candidate
65 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION / SUBCONJUNCTIVAL252 mgExact identifier — unii candidate
50 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY / VAGINALNAExact identifier — unii candidate
40 equally ranked IID candidates
TARTARIC ACIDTARTARIC ACIDW4888I119HSOLUTION / ORAL270 mgExact identifier — unii candidate
24 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE / ORAL238 mgExact identifier — unii candidate
88 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
c3da5b4a-4ab9-42ac-844f-9f1fbc0ba60785b08f4a-d25a-4786-b700-54dca45095ad2012-07-18WarningsExact identifier
spl id: c3da5b4a-4ab9-42ac-844f-9f1fbc0ba607
spl set id: 85b08f4a-d25a-4786-b700-54dca45095ad

Reported adverse events (FAERS/openFDA)#

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