NEUTROGENA PROTECT PLUS TINT MEDIUM TO DEEP 50- homosalate, octinoxate, octisalate, and oxybenzone lotion

Neutrogena PROTECT PLUS TINT MEDIUM TO DEEP 50 by

Drug Labeling and Warnings

Neutrogena PROTECT PLUS TINT MEDIUM TO DEEP 50 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 7%, Octinoxate 7.5%, Octisalate 5%, Oxybenzone 2%

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

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 32 mL Tube Label

N
Neutrogena®
protect
+tint
MEDIUM TO DEEP 50
MEDIUM TO DEEP 50

NET WT. 1.1 FL OZ. (32mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA PROTECT PLUS TINT MEDIUM TO DEEP 50 
homosalate, octinoxate, octisalate, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0490
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	70 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

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)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
Polysorbate 20 (UNII: 7T1F30V5YH)
Caramel (UNII: T9D99G2B1R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Xanthan Gum (UNII: TTV12P4NEE)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
Sorbic Acid (UNII: X045WJ989B)
Phenoxyethanol (UNII: HIE492ZZ3T)
FERRIC OXIDE RED (UNII: 1K09F3G675)
Mica (UNII: V8A1AW0880)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0490-1	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)