NDC Code(s) : 58414-2048-1
Packager : NeoStrata Company Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Exuviance Multi Protective Day Octinoxate and Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58414-2048
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate60 mg in 1 g
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP) 		Titanium Dioxide40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
TRIETHYLHEXANOIN(UNII: 7K3W1BIU6K)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
PEG-100 STEARATE(UNII: YD01N1999R)
GLUCONOLACTONE(UNII: WQ29KQ9POT)
DIMETHICONE(UNII: 92RU3N3Y1O)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DIMETHICONE PEG-7 PHOSPHATE(UNII: WTP86Y84TV)
DIETHYLENE GLYCOL MONOETHYL ETHER(UNII: A1A1I8X02B)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER(UNII: W59H9296ZG)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
LACTOBIONIC ACID(UNII: 65R938S4DV)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CUCUMBER(UNII: YY7C30VXJT)
ALTHAEA OFFICINALIS FLOWER(UNII: B3911G2Q52)
CHAMOMILE(UNII: FGL3685T2X)
ROSEMARY(UNII: IJ67X351P9)
VITIS VINIFERA SEED(UNII: C34U15ICXA)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONOL (600000 CST)(UNII: RKI3S914RT)
METHICONE (20 CST)(UNII: 6777U11MKT)
ALUMINUM OXIDE(UNII: LMI26O6933)
MAGNESIUM ALUMINUM SILICATE(UNII: 6M3P64V0NC)
AMMONIA(UNII: 5138Q19F1X)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
CITRIC ACID MONOHYDRATE(UNII: 2968PHW8QP)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
XANTHAN GUM(UNII: TTV12P4NEE)
POLYSORBATE 20(UNII: 7T1F30V5YH)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
CHLORPHENESIN(UNII: I670DAL4SZ)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58414-2048-11 in 1 CARTON
150 g in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 08/15/2013

PRINCIPAL DISPLAY PANEL

DERMATOLOGIST DEVELOPED

Exuviance®

Multi-Protective
Day Creme

sensitive / dry

with Sunscreen
Broad Spectrum SPF 20

Powerful antiaging benefits without irritation

Multi Antioxidant/PHA blend helps
strengthen and retexture sensitive skin

Net Wt 50 g / 1.75 oz

Principal Display Panel - 50 g Bottle Carton