NDC Code(s) : 76485-1012-1
Packager : Rimmel Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Moisture Renew Octinoxate LIPSTICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76485-1012
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate300 mg in 4 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate80 mg in 4 g
Inactive Ingredients
Ingredient Name Strength
CASTOR OIL(UNII: D5340Y2I9G)
CANDELILLA WAX(UNII: WL0328HX19)
Myristyl Lactate(UNII: 1D822OC34X)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL(UNII: 0QW9S92J3K)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Tocopherol(UNII: R0ZB2556P8)
Propylparaben(UNII: Z8IX2SC1OH)
Tribehenin(UNII: 8OC9U7TQZ0)
Sorbitan Isostearate(UNII: 01S2G2C1E4)
Water(UNII: 059QF0KO0R)
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
Silica Dimethyl Silylate(UNII: EU2PSP0G0W)
STANNIC OXIDE(UNII: KM7N50LOS6)
Butylene Glycol(UNII: 3XUS85K0RA)
Phenoxyethanol (UNII: HIE492ZZ3T)
PALMITOYL OLIGOPEPTIDE(UNII: HO4ZT5S86C)
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)(UNII: H5BJH23Z9A)
Caprylyl Glycol (UNII: 00YIU5438U)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
Methylparaben(UNII: A2I8C7HI9T)
Hexylene Glycol(UNII: KEH0A3F75J)
Ethylparaben(UNII: 14255EXE39)
Butylparaben(UNII: 3QPI1U3FV8)
Isobutylparaben(UNII: 0QQJ25X58G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76485-1012-14 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 10/20/2011

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