NDC Code(s) : 39765-004-01
Packager : Neutraderm, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Daily Wear Moisturizer SPF-20 Octinoxate, Octocrylene, Oxybenzone, Avobenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:39765-004
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 g
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE5 g in 100 g
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE3 g in 100 g
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE2.5 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ISOPROPYL PALMITATE(UNII: 8CRQ2TH63M)
MINERAL OIL(UNII: T5L8T28FGP)
DIMETHICONE(UNII: 92RU3N3Y1O)
CETYL ALCOHOL(UNII: 936JST6JCN)
STEARIC ACID(UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
GLYCERIN(UNII: PDC6A3C0OX)
CYCLOMETHICONE 5(UNII: 0THT5PCI0R)
DIMETHICONOL (250000 MW)(UNII: RKI3S914RT)
ETHYLHEXYL METHOXYCRYLENE(UNII: S3KFG6Q5X8)
ALOE VERA LEAF(UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER(UNII: P0M7O4Y7YD)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
APRICOT(UNII: 269CJD5GZ9)
ANIBA ROSAEODORA WOOD(UNII: NE01NKA8B2)
LIME PEEL(UNII: 544EQK5Q0W)
ORANGE PEEL(UNII: TI9T76XD44)
VANILLA(UNII: Q74T35078H)
CITRUS MAXIMA FRUIT RIND(UNII: 5NX3G75CA6)
MANGO(UNII: I629I3NR86)
TANGERINE PEEL(UNII: JU3D414057)
ALLANTOIN(UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
HYALURONATE SODIUM(UNII: YSE9PPT4TH)
METHYL GLUCETH-20(UNII: J3QD0LD11P)
ISOPROPYL MYRISTATE(UNII: 0RE8K4LNJS)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN(UNII: 147D247K3P)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
XANTHAN GUM(UNII: TTV12P4NEE)
TROLAMINE(UNII: 9O3K93S3TK)
EDETATE SODIUM(UNII: MP1J8420LU)
ACETYL OCTAPEPTIDE-3(UNII: 8K14HJF88S)
Product Characteristics
Color white (Off-White) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:39765-004-0143 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 03/01/2011

PRINCIPAL DISPLAY PANEL

Product Label