LIGHTENING SERUM- dicaprylyl ether cream

Lightening Serum by

Drug Labeling and Warnings

Lightening Serum by is a Otc medication manufactured, distributed, or labeled by Lange SAS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

KEY ACTIVE INGREDIENTS

Seaweed, Licorice Root and Pearl Protein Extracts

PURPOSE

LIGHTENING SERUM

Coup d'eclat with Seaweed extract and Pearl Protein

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

LIGHTENING SERUM LANGE
Coup d'eclat Serum is an intensive booster treatment, highly concentrated with whitening Complex. This soft and melting light-gel feel ultra-modern formula will help to: correct skin pigmentation to create a more even appearance, improve skin tone and clarity, creating a more radiant complexion, protect, revitalize, and sublime skin, reinforce action from other LANGE Lightening Products.

WARNINGS

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

DOSAGE & ADMINISTRATION

20 ml
0.68 FL. OZ

INACTIVE INGREDIENT

WATER
PEG-8
DICAPRYLYL ETHER
CYCLOPENTASILOXANE
MANNITOL
SODIUM POLYACRYLATE
PROPYLENE GLYCOL
GLYCERIN
PHENOXYETHANOL
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER
SODIUM PCA
PROPYLPARABEN
SODIUM GLUCONATE
DISODIUM EDTA
METHYLPARABEN
MAGNESIUM ASCORBYL PHOSPHATE
o-CYMEN-5-OL
ETHYLPARABEN
CITRIC ACID
SODIUM CITRATE
TOCOPHEROL
CITRUS NOBILIS (MANDARIN ORANGE) FRUIT EXTRACT
BUTYLENE GLYCOL
WALTHERIA INDICA LEAF EXTRACT
GLYCYRRHETINIC ACID
BAMBUSA VULGARIS LEAF/STEM EXTRACT
ASCOPHYLLUM NODOSUM EXTRACT
DEXTRIN
FERULIC ACID
GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT
MALIC ACID
HYDROLYZED CONCHIOLIN PROTEIN
TARTARIC ACID
FREESIA ALBA FLOWER EXTRACT
GARDENIA TAHITENSIS FLOWER EXTRACT
HIBISCUS SABDARIFFA FLOWER EXTRACT
LILIUM CANDIDUM FLOWER EXTRACT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIGHTENING SERUM 
dicaprylyl ether cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51830-022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) (CYCLOMETHICONE 5 - UNII:0THT5PCI0R)	CYCLOMETHICONE 5	0.35 mg  in 20 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
MANNITOL (UNII: 3OWL53L36A)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DICAPRYLYL ETHER (UNII: 77JZM5516Z)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
SODIUM GLUCONATE (UNII: R6Q3791S76)
EDETATE DISODIUM (UNII: 7FLD91C86K)
METHYLPARABEN (UNII: A2I8C7HI9T)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
ETHYLPARABEN (UNII: 14255EXE39)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TOCOPHEROL (UNII: R0ZB2556P8)
TANGERINE (UNII: KH3E3096OO)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
WALTHERIA INDICA LEAF (UNII: T69OLD6617)
ENOXOLONE (UNII: P540XA09DR)
BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)
ASCOPHYLLUM NODOSUM (UNII: 168S4EO8YJ)
ICODEXTRIN (UNII: 2NX48Z0A9G)
FERULIC ACID (UNII: AVM951ZWST)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MALIC ACID (UNII: 817L1N4CKP)
TARTARIC ACID (UNII: W4888I119H)
FREESIA ALBA FLOWER (UNII: 33X293N6JT)
GARDENIA TAITENSIS FLOWER (UNII: T0OCU8201Y)
HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)
LILIUM CANDIDUM FLOWER (UNII: COV655U2CJ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51830-022-02	20 mg in 1 BOX

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/18/2012

Labeler - Lange SAS (275956105)

Establishment
Name	Address	ID/FEI	Business Operations
Lange SAS		275956105	manufacture(51830-022)