NDC Code(s) : 67015-1101-0
Packager : Pierre Fabre Dermo Cosmetique

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

HAUTE PROTECTION High Protection Tinted Compact BROAD SPECTRUM SPF 50 HONEY TITANIUM DIOXIDE, ZINC OXIDE CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67015-1101
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 DIOXIDE18 g in 100 g
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE4.9 g in 100 g
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE(UNII: 92RU3N3Y1O)
HYDROGENATED POLYBUTENE (1300 MW)(UNII: 7D1YQ9Y5EZ)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
ISODECYL NEOPENTANOATE(UNII: W60VYE24XC)
SQUALANE(UNII: GW89575KF9)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
TALC(UNII: 7SEV7J4R1U)
ETHYLHEXYL HYDROXYSTEARATE(UNII: B7I80BVV5E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
POLYGLYCERYL-3 DIISOSTEARATE(UNII: 46P231IQV8)
WATER(UNII: 059QF0KO0R)
YELLOW WAX(UNII: 2ZA36H0S2V)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
TRIBEHENIN(UNII: 8OC9U7TQZ0)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67015-1101-010 g in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/13/2011

PRINCIPAL DISPLAY PANEL


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