NDC Code(s) : 58668-1619-1
Packager : Laboratoires Clarins

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Clarins UV PLUS ANTI-POLLUTION B.S. SPF 50, Sunscreen Multi-Protection Tint MediumHOMOSALATE,OCTOCRYLENE,OXYBENZONE,TITANIUM DIOXIDE LIQUID
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58668-1619
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE40 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE40 mg in 1 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE15 mg in 1 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE84 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
WATER(UNII: 059QF0KO0R)
ALCOHOL(UNII: 3K9958V90M)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
PEG/PPG-18/18 DIMETHICONE(UNII: 9H0AO7T794)
NYLON-12(UNII: 446U8J075B)
PEG-12 DIMETHICONE(UNII: ZEL54N6W95)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
GLYCERIN(UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
EDETATE DISODIUM(UNII: 7FLD91C86K)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
SODIUM LAUROYL GLUTAMATE(UNII: NCX1UU2D33)
LYSINE(UNII: K3Z4F929H6)
MAGNESIUM CHLORIDE(UNII: 02F3473H9O)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
RIBES NIGRUM FLOWER BUD(UNII: VYH9Y9BCCP)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
MUSKMELON(UNII: ZV095H5633)
LAPSANA COMMUNIS FLOWERING TOP(UNII: T9B77O7PZA)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58668-1619-11 in 1 CARTON 22/09/2015
150 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 09/22/2015

LABELER - Laboratoires Clarins(266317555)

PRINCIPAL DISPLAY PANEL

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