NDC Code(s) : 58668-2921-1
Packager : Laboratoires Clarins S.A.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CLARINS UV PLUS HP Broad Spectrum SPF 40 Sunscreen Multi-Protection Tint DEEPTITANIUM DIOXIDE LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58668-2921
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE81 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
WATER(UNII: 059QF0KO0R)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
DIMETHICONE(UNII: 92RU3N3Y1O)
ALCOHOL(UNII: 3K9958V90M)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
STEARIC ACID(UNII: 4ELV7Z65AP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
PEG/PPG-18/18 DIMETHICONE(UNII: 9H0AO7T794)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PEG/PPG-20/15 DIMETHICONE(UNII: 06R6X77P9C)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)(UNII: V2W71V8T0X)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
MICA(UNII: V8A1AW0880)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
EDETATE SODIUM(UNII: MP1J8420LU)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
ISOPROPYL TITANIUM TRIISOSTEARATE(UNII: 949E3KBJ1I)
GLYCERIN(UNII: PDC6A3C0OX)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
CUCUMIS MELO VAR. CANTALUPENSIS WHOLE(UNII: HUU66O04OX)
GERANIOL(UNII: L837108USY)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
THERMUS THERMOPHILUS(UNII: 415H64SACF)
BENZYL BENZOATE(UNII: N863NB338G)
BUTYLPHENYL METHYLPROPIONAL(UNII: T7540GJV69)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE(UNII: QUE43B9Z2Q)
LAPSANA COMMUNIS WHOLE(UNII: UXH42V064J)
LIMONENE, (+)-(UNII: GFD7C86Q1W)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
LINALOOL, (+)-(UNII: F4VNO44C09)
CAMELLIA SINENSIS WHOLE(UNII: C5M4585ZBZ)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
RHODIOLA ROSEA ROOT(UNII: 3S5ITS5ULN)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58668-2921-150 mL in 1 BOTTLE Type 0: Not a Combination Product25/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/25/2012

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