NDC Code(s) : 60232-6200-3, 60232-6200-8
Packager : Swiss-American Products

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Elta Block Zinc Oxide, Octinoxate, Octisalate LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60232-6200
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 g in 1000 g
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide70 g in 1000 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Phenoxyethanol(UNII: HIE492ZZ3T)
Petrolatum(UNII: 4T6H12BN9U)
Isopropyl Palmitate(UNII: 8CRQ2TH63M)
Octyl Stearate(UNII: 772Y4UFC8B)
Butylene Glycol(UNII: 3XUS85K0RA)
PEG-100 Stearate(UNII: YD01N1999R)
POLYISOBUTYLENE (1000 MW)(UNII: 5XB3A63Y52)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
DIMETHICONE 350(UNII: 2Y53S6ATLU)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S)(UNII: 5F4963KLHS)
2-HYDROXYETHYL ACRYLATE(UNII: 25GT92NY0C)
Triethoxycaprylylsilane(UNII: LDC331P08E)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60232-6200-385 g in 1 TUBE
2NDC:60232-6200-8240 g in 1 BOTTLE
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

Block 32 Artwork