NDC Code(s) : 71014-002-01, 71014-002-02
Packager : Eai-Jr286, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Sunscreen Face SPF 28 Octinioxate, Octocrylene, Titanium Dioxide STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71014-002
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE5 g in 100 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE5 g in 100 g
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE3 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER(UNII: WB5K9Y35Y9)
HEXYLDECYL ISOSTEARATE(UNII: 3V20TC06U5)
CERESIN(UNII: Q1LS2UJO3A)
PARAFFIN(UNII: I9O0E3H2ZE)
POLYGLYCERYL-2 TRIISOSTEARATE(UNII: 68DUY2D39A)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
SYNTHETIC WAX (1200 MW)(UNII: Q3Z4BCH099)
TOCOPHEROL(UNII: R0ZB2556P8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71014-002-021 in 1 CARTON 10/07/2016
1NDC:71014-002-019.5 g in 1 CYLINDER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 10/07/2016

PRINCIPAL DISPLAY PANEL

Vertra Elemental Resistance

Sunscreen Face Stick

UVA/UVB protection

Water resistant (80 minutes)

Color: Clear

9.5g NET WT.  .34 OZ

Box