NDC Code(s) : 49817-0064-1
Packager : Guerlain

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TERRACOTTA BRONZING MIST WITH SUNSCREEN SPF 10 02 MEDIUM OCTINOXATE POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49817-0064
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE25 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BUTANE(UNII: 6LV4FOR43R)
WATER(UNII: 059QF0KO0R)
ISOBUTANE(UNII: BXR49TP611)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PROPANE(UNII: T75W9911L6)
NYLON-12(UNII: 446U8J075B)
COCO-GLYCERIDES(UNII: ISE9I7DNUG)
SORBITAN ISOSTEARATE(UNII: 01S2G2C1E4)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONE(UNII: 92RU3N3Y1O)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
ZINC STEARATE(UNII: H92E6QA4FV)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
HEXYLENE GLYCOL(UNII: KEH0A3F75J)
TOCOPHEROL(UNII: R0ZB2556P8)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
BENZYL SALICYLATE(UNII: WAO5MNK9TU)
LINALOOL, (+/-)-(UNII: D81QY6I88E)
ISOMETHYL-.ALPHA.-IONONE(UNII: 9XP4LC555B)
.BETA.-CITRONELLOL, (R)-(UNII: P01OUT964K)
.ALPHA.-HEXYLCINNAMALDEHYDE(UNII: 7X6O37OK2I)
CINNAMYL ALCOHOL(UNII: SS8YOP444F)
GERANIOL(UNII: L837108USY)
EUGENOL(UNII: 3T8H1794QW)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ULTRAMARINE BLUE(UNII: I39WR998BI)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49817-0064-11 in 1 CARTON
175 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 final part352 04/10/2014

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