NDC Code(s) : 31645-192-01, 31645-192-02
Packager : Physicians Formula, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Super CC Color-Corection Care All Over Blur StickOctinoxate, Octocrylene, Oxybenzone, Titanium Dioxide, Zinc Oxide STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31645-192
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM)
OCTOCRYLENE4.2 g in 100 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y)
OXYBENZONE5.1 g in 100 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51)
OCTINOXATE5.6 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE4 g in 100 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP)
TITANIUM DIOXIDE5.2 g in 100 g
Inactive Ingredients
Ingredient Name Strength
HYDROXYCAPRIC ACID(UNII: B41993WR8W)
HYDROXYCAPRYLIC ACID(UNII: 0R6X0G0S8A)
KAOLIN(UNII: 24H4NWX5CO)
C12-15 ALKYL BENZOATE(UNII: A9EJ3J61HQ)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE 200(UNII: RGS4T2AS00)
MICA(UNII: V8A1AW0880)
ETHYLHEXYL PALMITATE(UNII: 2865993309)
SYNTHETIC WAX (1200 MW)(UNII: Q3Z4BCH099)
TEPRENONE(UNII: S8S8451A4O)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:31645-192-021 in 1 CARTON 01/01/2016
1NDC:31645-192-0113.5 g in 1 PACKAGE 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 01/01/2016

PRINCIPAL DISPLAY PANEL

PDP