NDC Code(s) : 42421-192-15
Packager : Emilia Personal Care

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aureli AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE GEL
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42421-192
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE10 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE5 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ISODODECANE(UNII: A8289P68Y2)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER(UNII: O4I3UFO6ZF)
DIDECYL ETHER(UNII: DA81HI310Z)
MICA(UNII: V8A1AW0880)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED(UNII: 1K09F3G675)
STANNIC OXIDE(UNII: KM7N50LOS6)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
PLUKENETIA VOLUBILIS SEED OIL(UNII: 8ED72Z8J1Z)
TOCOPHEROL(UNII: R0ZB2556P8)
ASTAXANTHIN(UNII: 8XPW32PR7I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42421-192-151 in 1 CARTON
150 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2015

PRINCIPAL DISPLAY PANEL



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