NDC Code(s) : 31645-183-01, 31645-183-02
Packager : Physicians Formula Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Super BB All in One Beauty Balm Bronzer and BlushTitanium Dioxide, Zinc Oxide POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31645-183
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE15 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE10 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ZINC STEARATE(UNII: H92E6QA4FV)
OCTYLDODECYL STEAROYL STEARATE(UNII: 3D47Q6D93C)
CALCIUM ALUMINUM BOROSILICATE(UNII: 3JRB8A35M0)
LAUROYL LYSINE(UNII: 113171Q70B)
POTASSIUM SORBATE(UNII: 1VPU26JZZ4)
MICA(UNII: V8A1AW0880)
GLYCERYL CAPRYLATE(UNII: TM2TZD4G4A)
GLYCERIN(UNII: PDC6A3C0OX)
BORON NITRIDE(UNII: 2U4T60A6YD)
WATER(UNII: 059QF0KO0R)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:31645-183-021 in 1 CARTON 01/01/2015
1NDC:31645-183-018.4 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