NDC Code(s) : 58414-3100-1
Packager : NeoStrata Company Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

NeoStrata Sheer Physical Protection TITANIUM DIOXIDE and ZINC OXIDE LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58414-3100
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 DIOXIDE70 mg in 1 mL
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
ISODODECANE(UNII: A8289P68Y2)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
HYDROGENATED POLYDECENE (550 MW)(UNII: U333RI6EB7)
BUTYLOCTYL SALICYLATE(UNII: 2EH13UN8D3)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
ALUMINUM OXIDE(UNII: LMI26O6933)
LACTOBIONIC ACID(UNII: 65R938S4DV)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE(UNII: TYP81E471F)
PHENETHYL BENZOATE(UNII: 0C143929GK)
NYLON-12(UNII: 446U8J075B)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
EPIGALLOCATECHIN GALLATE(UNII: BQM438CTEL)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
ISOHEXADECANE(UNII: 918X1OUF1E)
TOCOPHEROL(UNII: R0ZB2556P8)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)(UNII: 59TL3WG5CO)
DIPROPYLENE GLYCOL(UNII: E107L85C40)
DISTEARDIMONIUM HECTORITE(UNII: X687XDK09L)
MAGNESIUM SULFATE, UNSPECIFIED FORM(UNII: DE08037SAB)
METHICONE (20 CST)(UNII: 6777U11MKT)
PROPYLENE CARBONATE(UNII: 8D08K3S51E)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
SODIUM BISULFITE(UNII: TZX5469Z6I)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58414-3100-11 in 1 CARTON 02/01/2015
150 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 02/01/2015 12/29/2018

PRINCIPAL DISPLAY PANEL

NeoStrata ® TARGETED TREATMENT

Intensive
treatment for
specific concerns

Sheer
Physical
Protection

with Sunscreen
Broad Spectrum
SPF 50 PA++++

50 mL / 1.7 fl oz

Principal Display Panel - 50 mL Bottle Carton