NDC Code(s) : 61589-0011-0, 61589-0011-1
Packager : BCM Cosmetique SAS

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Burberry Fresh Glow Foundation Luminous Fluid Mocha No. 64 OCTINOXATE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61589-0011
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE70 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
PROPANEDIOL(UNII: 5965N8W85T)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
MICA(UNII: V8A1AW0880)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
DISODIUM STEAROYL GLUTAMATE(UNII: 45ASM2L11M)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
POLYGLYCERYL-4 ISOSTEARATE(UNII: 820DPX33S7)
HEXYL LAURATE(UNII: 4CG9F9W01Q)
TEA LEAF(UNII: GH42T47V24)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
PANTHENOL(UNII: WV9CM0O67Z)
GLYCERIN(UNII: PDC6A3C0OX)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
ROSA CANINA FRUIT(UNII: 3TNW8D08V3)
PANTOLACTONE, (R)-(UNII: J288D7O0JS)
PHENYLETHYL ALCOHOL(UNII: ML9LGA7468)
TOCOPHEROL(UNII: R0ZB2556P8)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)(UNII: 255PIF62MS)
RUTIN(UNII: 5G06TVY3R7)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61589-0011-01 in 1 CARTON
130 mL in 1 BOTTLE
2NDC:61589-0011-13 in 1 BOX
21 in 1 CARTON
230 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/17/2014

PRINCIPAL DISPLAY PANEL

Mocha No 64