NDC Code(s) : 10812-009-01
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Neutrogena Revitalizing Lip Balm Octinoxate and Oxybenzone LIPSTICK
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-009
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Octinoxate(UNII: 4Y5P7MUD51)
(Octinoxate - UNII:4Y5P7MUD51) 		Octinoxate75 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
petrolatum(UNII: 4T6H12BN9U)
phenyl trimethicone(UNII: DR0K5NOJ4R)
lanolin alcohols(UNII: 884C3FA9HE)
myristyl myristate(UNII: 4042ZC00DY)
high density polyethylene(UNII: UG00KM4WR7)
cetyl lactate(UNII: A7EVH2RK4O)
shea butter(UNII: K49155WL9Y)
candelilla wax(UNII: WL0328HX19)
silicon dioxide(UNII: ETJ7Z6XBU4)
zinc(UNII: J41CSQ7QDS)
carnauba wax(UNII: R12CBM0EIZ)
ethylhexyl palmitate(UNII: 2865993309)
tribehenin(UNII: 8OC9U7TQZ0)
sorbitan isostearate(UNII: 01S2G2C1E4)
palmitoyl hexapeptide-12(UNII: HO4ZT5S86C)
pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)(UNII: 255PIF62MS)
isopropyl titanium triisostearate(UNII: 949E3KBJ1I)
aluminum hydroxide(UNII: 5QB0T2IUN0)
stearic acid(UNII: 4ELV7Z65AP)
copper(UNII: 789U1901C5)
mica(UNII: V8A1AW0880)
titanium dioxide(UNII: 15FIX9V2JP)
d&c red no. 7(UNII: ECW0LZ41X8)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-009-011 in 1 BLISTER PACK 12/01/2010
14.2 g in 1 TUBE 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 12/01/2010 12/01/2018

PRINCIPAL DISPLAY PANEL

Sheer
Shimmer 10
SHEER TINT

revitalizing
lip balm

with
sunscreen
SPF20
Softer, rosier & healthier-looking
lips, even after you take it off!

Dramatization

before
after

Neutrogena ®

NET WT. 0.15 OZ. (4.2g)

Principal Display Panel - 4.2g Tube Blister Pack