NEUTROGENA REVITALIZING LIP BALM SPF 20 - FRESH PLUM 60- octinoxate and oxybenzone lipstick NEUTROGENA REVITALIZING LIP BALM SPF 20 - SHEEER SHIMMER 10- octinoxate and oxybenzone lipstick NEUTROGENA REVITALIZING LIP BALM SPF 20 - SOFT CARAMEL 50- octinoxate and oxybenzone lipstick NEUTROGENA REVITALIZING LIP BALM SPF 20 - HEALTHY BLUSH 20- octinoxate and oxybenzone lipstick NEUTROGENA REVITALIZING LIP BALM SPF 20 - SUNNY BERRY 30- octinoxate and oxybenzone lipstick NEUTROGENA REVITALIZING LIP BALM SPF 20 - PETAL GLOW 40- octinoxate and oxybenzone lipstick

Neutrogena Revitalizing Lip Balm by

Drug Labeling and Warnings

Neutrogena Revitalizing Lip Balm by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Fresh Plum 60

FRESH
PLUM 60
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Sheer Shimmer 10

SHEER
SHIMMER 10
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Soft Caramel 50

SOFT
CARAMEL 50
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Healthy Blush 20

HEALTHY
BLUSH 20
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Sunny Berry 30

SUNNY
BERRY 30
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL - 4.2 g Tube Blister Pack - Petal Glow 40

PETAL
GLOW 40
SHEER TINT

revitalizing
lip balm
with
sunscreen
SPF 20

Softer, rosier and healthier-looking
lips, even after you take it off!
dramatization

before                  after

Neutrogena®

NET WT 0.15 OZ (4.2 g)

INGREDIENTS AND APPEARANCE

NEUTROGENA REVITALIZING LIP BALM   SPF 20 - FRESH PLUM 60
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0256
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
Petrolatum (UNII: 4T6H12BN9U)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lanolin Alcohols (UNII: 884C3FA9HE)
CERESIN (UNII: Q1LS2UJO3A)
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 TRIPEPTIDE-1 (UNII: RV743D216M)
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)
Ferric Oxide Red (UNII: 1K09F3G675)
D&C Red No. 7 (UNII: ECW0LZ41X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0256-1	1 in 1 BLISTER PACK	11/01/2010
1		4.2 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	11/01/2010

NEUTROGENA REVITALIZING LIP BALM   SPF 20 - SHEEER SHIMMER 10
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0251
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
Petrolatum (UNII: 4T6H12BN9U)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lanolin Alcohols (UNII: 884C3FA9HE)
CERESIN (UNII: Q1LS2UJO3A)
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 TRIPEPTIDE-1 (UNII: RV743D216M)
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)
Ferric Oxide Red (UNII: 1K09F3G675)
D&C Red No. 7 (UNII: ECW0LZ41X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0251-1	1 in 1 BLISTER PACK	11/01/2010
1		4.2 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	11/01/2010

NEUTROGENA REVITALIZING LIP BALM   SPF 20 - SOFT CARAMEL 50
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0252
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
Petrolatum (UNII: 4T6H12BN9U)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lanolin Alcohols (UNII: 884C3FA9HE)
CERESIN (UNII: Q1LS2UJO3A)
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 TRIPEPTIDE-1 (UNII: RV743D216M)
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)
Ferric Oxide Red (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0252-1	1 in 1 BLISTER PACK	11/01/2010
1		4.2 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	11/01/2010

NEUTROGENA REVITALIZING LIP BALM   SPF 20 - HEALTHY BLUSH 20
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0253
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
Petrolatum (UNII: 4T6H12BN9U)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lanolin Alcohols (UNII: 884C3FA9HE)
CERESIN (UNII: Q1LS2UJO3A)
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 TRIPEPTIDE-1 (UNII: RV743D216M)
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)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
Aluminum Oxide (UNII: LMI26O6933)
D&C Red No. 6 (UNII: 481744AI4O)
D&C Red No. 7 (UNII: ECW0LZ41X8)
Stannic Oxide (UNII: KM7N50LOS6)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0253-1	1 in 1 BLISTER PACK	11/01/2010
1		4.2 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	11/01/2010

NEUTROGENA REVITALIZING LIP BALM   SPF 20 - SUNNY BERRY 30
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0255
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
Petrolatum (UNII: 4T6H12BN9U)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lanolin Alcohols (UNII: 884C3FA9HE)
CERESIN (UNII: Q1LS2UJO3A)
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 TRIPEPTIDE-1 (UNII: RV743D216M)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Stearic Acid (UNII: 4ELV7Z65AP)
Isopropyl Titanium Triisostearate (UNII: 949E3KBJ1I)
Copper (UNII: 789U1901C5)
Mica (UNII: V8A1AW0880)
Titanium Dioxide (UNII: 15FIX9V2JP)
Ferric Oxide Red (UNII: 1K09F3G675)
D&C Red No. 7 (UNII: ECW0LZ41X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0255-1	1 in 1 BLISTER PACK	11/01/2010
1		4.2 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	11/01/2010

NEUTROGENA REVITALIZING LIP BALM   SPF 20 - PETAL GLOW 40
octinoxate and oxybenzone lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0254
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
Petrolatum (UNII: 4T6H12BN9U)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Lanolin Alcohols (UNII: 884C3FA9HE)
CERESIN (UNII: Q1LS2UJO3A)
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 TRIPEPTIDE-1 (UNII: RV743D216M)
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)
Ferric Oxide Red (UNII: 1K09F3G675)
FD&C Yellow No. 5 (UNII: I753WB2F1M)
Aluminum Oxide (UNII: LMI26O6933)
D&C Red No. 7 (UNII: ECW0LZ41X8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0254-1	1 in 1 BLISTER PACK	11/01/2010
1		4.2 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	11/01/2010

Labeler - Johnson & Johnson Consumer Inc. (002347102)