NEUTROGENA REVITALIZING LIP BALM SPF 20 - FRESH PLUM 60- octinoxate and oxybenzone lipstick 
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Neutrogena® Revitalizing Lip Balm with Sunscreen SPF 20
Fresh Plum 60

Drug Facts

Active ingredients

Octinoxate 7.5%, Oxybenzone 5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

  • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
  • For external use only

  • Do not use on damaged or broken skin

  • When using this product keep out of eyes. Rinse with water to remove

  • Stop use and ask a doctor if rash occurs

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

For Sunscreen Use

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor

Other information

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

Hydrogenated Polyisobutene, Petrolatum, Polybutene, Phenyl Trimethicone, Hydrogenated Lanolin, Ozokerite, Myristyl Myristate, Polyethylene, Cetyl Lactate, Butyrospermum Parkii (Shea) Butter, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Euphorbia Cerifera (Candelilla) Wax, Silica, Zinc, Stearoxymethicone/Dimethicone Copolymer, Copernicia Cerifera (Carnauba) Wax, Synthetic Wax, Ethylhexyl Palmitate, Tribehenin, Sorbitan Isostearate, Palmitoyl Oligopeptide, Silica Silylate, Flavor, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Isopropyl Titanium Triisostearate, Aluminum Hydroxide, Stearic Acid, Copper Powder, Mica, Titanium Dioxide, Iron Oxides, Red 7

Questions or comments?

Call toll-free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Container

FRESH
PLUM 60
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 - 4.2 g Tube Container
NEUTROGENA REVITALIZING LIP BALM  SPF 20 - FRESH PLUM 60
octinoxate and oxybenzone lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10812-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10812-008-011 in 1 BLISTER PACK12/01/201012/01/2018
14.2 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35212/01/201012/01/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2017
Document Id: 2670618d-0e8a-4738-b15f-9351a994783b
Set id: 9fc0a05e-0929-4ce1-8c95-eb8284c8be25
Version: 3
Effective Time: 20170105
 
Johnson & Johnson Consumer Inc.