NDC Code(s) : 76150-211-23
Packager : Bell International Labroatories, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Yerba Mate Mineral Sunscreen SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76150-211
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE12 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
HEPTYL UNDECYLENATE(UNII: W77QUB6GXO)
JOJOBA OIL, RANDOMIZED(UNII: 7F0EV20QYL)
METHYL DIHYDROABIETATE(UNII: 7666FJ0J9F)
SAFFLOWER OIL(UNII: 65UEH262IS)
CAPRYLHYDROXAMIC ACID(UNII: UPY805K99W)
GLYCERIN(UNII: PDC6A3C0OX)
COCO GLUCOSIDE(UNII: ICS790225B)
ILEX PARAGUARIENSIS LEAF(UNII: 1Q953B4O4F)
WATER(UNII: 059QF0KO0R)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
BENTONITE(UNII: A3N5ZCN45C)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76150-211-2390 mL in 1 CAN Type 0: Not a Combination Product08/01/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 08/01/2015

PRINCIPAL DISPLAY PANEL

PDP