NDC Code(s) : 71014-004-01, 71014-004-02
Packager : Eai-jr 286, Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Foundation Sunscreen Face Broad Spectrum SPF 38 Titanium Dioxide STICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71014-004
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE24.15 g in 100 g
Inactive Ingredients
Ingredient Name Strength
ALUMINUM HYDROXIDE(UNII: 5QB0T2IUN0)
BUTYLPARABEN(UNII: 3QPI1U3FV8)
HEXYLDECYL ISOSTEARATE(UNII: 3V20TC06U5)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
MICA(UNII: V8A1AW0880)
CERESIN(UNII: Q1LS2UJO3A)
PARAFFIN(UNII: I9O0E3H2ZE)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
STEARIC ACID(UNII: 4ELV7Z65AP)
STEARYL GLYCYRRHETINATE(UNII: 3YYE6VJS0P)
SYNTHETIC WAX (1200 MW)(UNII: Q3Z4BCH099)
TOCOPHEROL(UNII: R0ZB2556P8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71014-004-021 in 1 BOX 10/07/2016
1NDC:71014-004-0111 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

Foundation

Sunscreen Face Stick

Broad Spectrum SPF 38

Water Resistant (80 minutes)

Color Kona Gold

11g Net Wt. .39 oz

Box