NEUTROGENA PROTECT PLUS TINT IVORY TO FAIR 10- homosalate, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion NEUTROGENA PROTECT PLUS TINT FAIR TO LIGHT 20- homosalate, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion NEUTROGENA PROTECT PLUS TINT LIGHT TO TAN 30- homosalate, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion NEUTROGENA PROTECT PLUS TINT TAN TO MEDIUM 40- homosalate, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion

Neutrogena PROTECT Plus TINT TAN TO MEDIUM 40 by

Drug Labeling and Warnings

Neutrogena PROTECT Plus TINT TAN TO MEDIUM 40 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

Homosalate 5%, Octinoxate 7.5%, Octisalate 5%, Oxybenzone 2%, Titanium Dioxide 2.9%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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
• reapply:
  • at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
• Sun protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. – 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses
• 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

Water, Phenyl Trimethicone, Cetyl Dimethicone, Butylene Glycol, Silica, Cetearyl Alcohol, Barium Sulfate, PEG-100 Stearate, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Squalane, Bisabolol, Caprylyl Glycol, Magnesium Aluminum Silicate, Dipotassium Glycyrrhizate, Polysorbate 20, Polymethyl Methacrylate, Cetyl Hydroxyethylcellulose, Polysorbate 60, Xanthan Gum, Tetrasodium EDTA, Sorbic Acid, PEG-12 Dimethicone, Tocopheryl Acetate, Pantothenic Acid, Retinyl Palmitate, Ascorbic Acid, Iron Oxides, Mica, Titanium Dioxide

Questions?

800-480-4812; Outside US, dial collect 215-273-8755 www.neutrogena.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Ivory To Fair 10

N
Neutrogena®
protect
+tint
IVORY TO FAIR 10
IVORY TO FAIR 10

NET WT. 1.1 FL OZ. (32mL)

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Fair To Light 20

N
Neutrogena®
protect
+tint
FAIR TO LIGHT 20
FAIR TO LIGHT 20

NET WT. 1.1 FL OZ. (32mL)

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Light To Tan 30

N
Neutrogena®
protect
+tint
LIGHT TO TAN 30
LIGHT TO TAN 30
NET WT. 1.1 FL OZ. (32mL)

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label - Tan To Medium 40

N
Neutrogena®
protect
+tint
TAN TO MEDIUM 40
TAN TO MEDIUM 40

NET WT. 1.1 FL OZ. (32mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA PROTECT PLUS TINT IVORY TO FAIR 10 
homosalate, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0491
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	50 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	20 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	29 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Butylene Glycol (UNII: 3XUS85K0RA)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Barium Sulfate (UNII: 25BB7EKE2E)
Pantothenic Acid (UNII: 19F5HK2737)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Squalane (UNII: GW89575KF9)
Levomenol (UNII: 24WE03BX2T)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Polysorbate 60 (UNII: CAL22UVI4M)
Peg-12 Dimethicone (300 Cst) (UNII: ZEL54N6W95)
Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)
Polysorbate 20 (UNII: 7T1F30V5YH)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Edetate Sodium (UNII: MP1J8420LU)
Xanthan Gum (UNII: TTV12P4NEE)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S At 1.5%) (UNII: 86FQE96TZ4)
Caprylyl Glycol (UNII: 00YIU5438U)
Sorbic Acid (UNII: X045WJ989B)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ferric Oxide Red (UNII: 1K09F3G675)
Mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0491-1	32 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2018

NEUTROGENA PROTECT PLUS TINT FAIR TO LIGHT 20 
homosalate, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0489
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	50 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	20 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	29 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Butylene Glycol (UNII: 3XUS85K0RA)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Barium Sulfate (UNII: 25BB7EKE2E)
Pantothenic Acid (UNII: 19F5HK2737)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Squalane (UNII: GW89575KF9)
Levomenol (UNII: 24WE03BX2T)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Polysorbate 60 (UNII: CAL22UVI4M)
Peg-12 Dimethicone (300 Cst) (UNII: ZEL54N6W95)
Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)
Polysorbate 20 (UNII: 7T1F30V5YH)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Edetate Sodium (UNII: MP1J8420LU)
Xanthan Gum (UNII: TTV12P4NEE)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S At 1.5%) (UNII: 86FQE96TZ4)
Caprylyl Glycol (UNII: 00YIU5438U)
Sorbic Acid (UNII: X045WJ989B)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ferric Oxide Red (UNII: 1K09F3G675)
Mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0489-1	32 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2018

NEUTROGENA PROTECT PLUS TINT LIGHT TO TAN 30 
homosalate, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0502
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	50 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	20 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	29 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Butylene Glycol (UNII: 3XUS85K0RA)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Barium Sulfate (UNII: 25BB7EKE2E)
Pantothenic Acid (UNII: 19F5HK2737)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Squalane (UNII: GW89575KF9)
Levomenol (UNII: 24WE03BX2T)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Polysorbate 60 (UNII: CAL22UVI4M)
Peg-12 Dimethicone (300 Cst) (UNII: ZEL54N6W95)
Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)
Polysorbate 20 (UNII: 7T1F30V5YH)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Edetate Sodium (UNII: MP1J8420LU)
Xanthan Gum (UNII: TTV12P4NEE)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S At 1.5%) (UNII: 86FQE96TZ4)
Caprylyl Glycol (UNII: 00YIU5438U)
Sorbic Acid (UNII: X045WJ989B)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ferric Oxide Red (UNII: 1K09F3G675)
Mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0502-1	32 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2018

NEUTROGENA PROTECT PLUS TINT TAN TO MEDIUM 40 
homosalate, octinoxate, octisalate, oxybenzone, and titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0503
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	50 mg  in 1 mL
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	20 mg  in 1 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	29 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Butylene Glycol (UNII: 3XUS85K0RA)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Peg-100 Stearate (UNII: YD01N1999R)
Barium Sulfate (UNII: 25BB7EKE2E)
Pantothenic Acid (UNII: 19F5HK2737)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Squalane (UNII: GW89575KF9)
Levomenol (UNII: 24WE03BX2T)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Polysorbate 60 (UNII: CAL22UVI4M)
Peg-12 Dimethicone (300 Cst) (UNII: ZEL54N6W95)
Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)
Polysorbate 20 (UNII: 7T1F30V5YH)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Edetate Sodium (UNII: MP1J8420LU)
Xanthan Gum (UNII: TTV12P4NEE)
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S At 1.5%) (UNII: 86FQE96TZ4)
Caprylyl Glycol (UNII: 00YIU5438U)
Sorbic Acid (UNII: X045WJ989B)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ferric Oxide Red (UNII: 1K09F3G675)
Mica (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0503-1	32 mL in 1 TUBE; Type 0: Not a Combination Product	12/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	12/01/2018

Labeler - Johnson & Johnson Consumer Inc. (002347102)