NDC Code(s) : 60232-2578-3
Packager : Swiss-American Products

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EltaMD UV PhysicalSPF 41 EltaMD UV Physical SPF 41 LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60232-2578
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 Oxide90 g in 1000 g
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide70 g in 1000 g
Inactive Ingredients
Ingredient Name Strength
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
Aluminum Hydroxide(UNII: 5QB0T2IUN0)
Butylene Glycol(UNII: 3XUS85K0RA)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
DIMETHICONE(UNII: 92RU3N3Y1O)
METHICONE (20 CST)(UNII: 6777U11MKT)
Hydrated Silica(UNII: Y6O7T4G8P9)
Iodopropynyl Butylcarbamate(UNII: 603P14DHEB)
Isopropyl Palmitate(UNII: 8CRQ2TH63M)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
Linoleic Acid(UNII: 9KJL21T0QJ)
Octyl Stearate(UNII: 772Y4UFC8B)
Octyldodecyl Neopentanoate(UNII: X8725R883T)
Oleth-3 Phosphate(UNII: 8Q0Z18J1VL)
Phenoxyethanol(UNII: HIE492ZZ3T)
POLYISOBUTYLENE (1000 MW)(UNII: 5XB3A63Y52)
Polysorbate 20(UNII: 7T1F30V5YH)
water(UNII: 059QF0KO0R)
QUERCETIN(UNII: 9IKM0I5T1E)
vitamin a palmitate(UNII: 1D1K0N0VVC)
Sodium Hydroxide(UNII: 55X04QC32I)
Sodium Selenite(UNII: HIW548RQ3W)
ferric oxide yellow(UNII: EX438O2MRT)
ferric oxide red(UNII: 1K09F3G675)
brown iron oxide(UNII: 1N032N7MFO)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
.alpha.-lipoic acid(UNII: 73Y7P0K73Y)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
Triethoxycaprylylsilane(UNII: LDC331P08E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60232-2578-385 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 04/30/2002

PRINCIPAL DISPLAY PANEL

Image of Tube Label