NDC Code(s) : 10812-010-01
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:10812-010
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)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-010-011 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

Soft
Caramel 50
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