NDC Code(s) : 60232-2510-8
Packager : Swiss American Products

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EltaMD UV Lip BalmLip Balm with Sunscreen CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60232-2510
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 OXIDE50 g in 1000 g
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE75 g in 1000 g
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE WAX(UNII: XOF597Q3KY)
PETROLATUM(UNII: 4T6H12BN9U)
ASCORBYL PALMITATE(UNII: QN83US2B0N)
ALPHA LIPOIC ACID(UNII: 73Y7P0K73Y)
QUERCETIN(UNII: 9IKM0I5T1E)
RICINUS COMMUNIS SEED(UNII: 7EK4SFN1TX)
LAURYL LAURATE(UNII: GPW77G0937)
OLEA EUROPAEA FRUIT VOLATILE OIL(UNII: 8E7358CX1J)
HYDROGENATED CASTOR OIL(UNII: ZF94AP8MEY)
HYDROGENATED SOYBEAN OIL(UNII: A2M91M918C)
GLYCERYL BEHENATE(UNII: R8WTH25YS2)
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
CAESALPINIA SPINOSA RESIN(UNII: WL3883U2PO)
VANILLA PLANIFOLIA OIL(UNII: 0A3F415158)
PEPPERMINT OIL(UNII: AV092KU4JH)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
GLYCERYL STEARATE SE(UNII: FCZ5MH785I)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
WHITE WAX(UNII: 7G1J5DA97F)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CANDELILLA WAX(UNII: WL0328HX19)
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60232-2510-88 g in 1 TUBE 27/11/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 11/27/2012

PRINCIPAL DISPLAY PANEL

UV Lip Balm Artwork