NDC Code(s) : 31645-184-01, 31645-184-02
Packager : Physicians Formula Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Super CC Color Correction Care CC Compact CreamTitanium Dioxide, Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31645-184
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE4.54 g in 100 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE3.53 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MICA(UNII: V8A1AW0880)
POLYBUTENE (1400 MW)(UNII: 1NA5AO9GH7)
NEOPENTYL GLYCOL DIHEPTANOATE(UNII: 5LKW3C543X)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
C10-18 TRIGLYCERIDES(UNII: 43AGM4PHPI)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
CANDELILLA WAX(UNII: WL0328HX19)
TEPRENONE(UNII: S8S8451A4O)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
NYLON-12(UNII: 446U8J075B)
HYDROXYCAPRIC ACID(UNII: B41993WR8W)
HYDROXYCAPRYLIC ACID(UNII: 0R6X0G0S8A)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
TETRAHEXYLDECYL ASCORBATE(UNII: 9LBV3F07AZ)
OCTYLDODECYL NEOPENTANOATE(UNII: X8725R883T)
CALCIUM ALUMINUM BOROSILICATE(UNII: 3JRB8A35M0)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:31645-184-021 in 1 CARTON 01/01/2015
1NDC:31645-184-018 g in 1 CONTAINER 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 01/01/2015

PRINCIPAL DISPLAY PANEL

PDP