NDC Code(s) : 71014-006-01
Packager : Eai-Jr286, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Elemental Resistance Broad Spectrum SPF 50 Octyl Methoxycinnamate, Oxybenzone, Titanium Dioxide, Zince Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71014-006
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE(UNII: 4Y5P7MUD51)
(OCTINOXATE - UNII:4Y5P7MUD51) 		OCTINOXATE6 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE5 g in 100 mL
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
(TITANIUM DIOXIDE - UNII:15FIX9V2JP) 		TITANIUM DIOXIDE6.3 g in 100 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION9.9 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
LAURYL PEG/PPG-18/18 METHICONE(UNII: ZJ5S27D9NX)
METHYL GLUCOSE DIOLEATE(UNII: FA9KFJ4Z6P)
METHYLCHLOROISOTHIAZOLINONE(UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE(UNII: 229D0E1QFA)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
WATER(UNII: 059QF0KO0R)
SILICA DIMETHYL SILYLATE(UNII: EU2PSP0G0W)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
SODIUM DODECYLBENZENESULFONATE(UNII: 554127163Y)
STEARIC ACID(UNII: 4ELV7Z65AP)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
XANTHAN GUM(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71014-006-013785 mL in 1 PAIL Type 0: Not a Combination Product27/10/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 10/27/2016

PRINCIPAL DISPLAY PANEL

Vertra

Elemental Resistance

SunProtectionCReam

Broad Spectrum SPF 50+

 UVA/UVB Protection

Water Resistant (80 minutes)

Net Wt. 2.8oz (80g)

Box