NDC Code(s) : 67226-2830-9, 67226-2830-2, 67226-2830-4
Packager : Vivier Pharma Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SHEER BROAD SPECTRUM SPF30ZINC OXIDE, OCTINOXATE, OCTISALATE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67226-2830
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION99 mg in 1 mL
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 mg in 1 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
DOCOSANOL(UNII: 9G1OE216XY)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
POLYOXYL 20 CETOSTEARYL ETHER(UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
CYCLOMETHICONE 4(UNII: CZ227117JE)
DIETHYLHEXYL 2,6-NAPHTHALATE(UNII: I0DQJ7YGXM)
ETHYLPARABEN(UNII: 14255EXE39)
METHYLPARABEN(UNII: A2I8C7HI9T)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STEAROYL GLUTAMATE(UNII: 65A9F4P024)
EDETATE SODIUM(UNII: MP1J8420LU)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67226-2830-91 in 1 CARTON 11/11/2017
190 mL in 1 BOTTLE Type 0: Not a Combination Product
2NDC:67226-2830-2250 mL in 1 TUBE Type 0: Not a Combination Product11/11/2017
3NDC:67226-2830-41 in 1 CARTON 11/11/2017
34 mL in 1 TUBE Type 0: Not a Combination Product11/11/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 11/11/2017

PRINCIPAL DISPLAY PANEL

Bottle1Bottle1