NDC Code(s) : 60232-2282-3, 60232-2282-8
Packager : Swiss-American Products

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EltaMD UV Shield Zinc Oxide, Octinoxate LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60232-2282
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 Oxide90 g in 1000 g
Inactive Ingredients
Ingredient Name Strength
water(UNII: 059QF0KO0R)
Phenoxyethanol(UNII: HIE492ZZ3T)
Cetearyl Glucoside(UNII: 09FUA47KNA)
Isopropyl Palmitate(UNII: 8CRQ2TH63M)
Octyl Stearate(UNII: 772Y4UFC8B)
Oleth-3 Phosphate(UNII: 8Q0Z18J1VL)
Triethoxycaprylylsilane(UNII: LDC331P08E)
2-HYDROXYETHYL ACRYLATE(UNII: 25GT92NY0C)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
SODIUM ACRYLOYLDIMETHYLTAURATE(UNII: 2T9Q6EKI0G)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
COCONUT ALCOHOL(UNII: 13F4MW8Y9K)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
POLYISOBUTYLENE (1000 MW)(UNII: 5XB3A63Y52)
Iodopropynyl Butylcarbamate(UNII: 603P14DHEB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60232-2282-385 g in 1 TUBE
2NDC:60232-2282-8226 g in 1 BOTTLE, PUMP
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

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