NDC Code(s) : 31645-151-01, 31645-151-02
Packager : Physicians Formula Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Healthy Wear Powder Foundation Octinoxate, Titanium Dioxide, Zinc Oxide POWDER
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:31645-151
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE4 g in 100 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE21 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
DIMETHICONE(UNII: 92RU3N3Y1O)
GENISTEIN(UNII: DH2M523P0H)
ENOXOLONE(UNII: P540XA09DR)
ALPHA LIPOIC ACID(UNII: 73Y7P0K73Y)
TOMATO(UNII: Z4KHF2C175)
SQUALANE(UNII: GW89575KF9)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL-(UNII: WR1WPI7EW8)
UBIDECARENONE(UNII: EJ27X76M46)
ZINC STEARATE(UNII: H92E6QA4FV)
EDETATE DISODIUM(UNII: 7FLD91C86K)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
SODIUM DEHYDROACETATE(UNII: 8W46YN971G)
SORBITAN SESQUIOLEATE(UNII: 0W8RRI5W5A)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:31645-151-021 in 1 BOX 03/01/2010
1NDC:31645-151-019.6 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 03/01/2010

PRINCIPAL DISPLAY PANEL

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