Neutrogena® Sensitive Skin Sunscreen Lotion Broad Spectrum SPF 60+

Neutrogena Sensitive Skin by

Drug Labeling and Warnings

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

Drug Details [pdf]

NEUTROGENA SENSITIVE SKIN  SUNSCREEN BROAD SPECTRUM SPF60 PLUS- titanium dioxide and zinc oxide lotion 
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® Sensitive Skin Sunscreen Lotion Broad Spectrum SPF 60+

Drug Facts

Active ingredients

Titanium Dioxide 4.9% , Zinc Oxide 4.7%

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

  • Apply generously and evenly15 minutes before sun exposure
  • reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • 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, butyloctyl salicylate, beeswax, styrene/acrylates copolymer, silica, butylene glycol, PEG-8, glyceryl stearate, PEG-100 stearate, cetyl dimethicone, benzyl alcohol, dimethicone, methicone, arachidyl alcohol, polyhydroxystearic acid, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-8 laurate, xanthan gum, isohexadecane, behenyl alcohol, trisiloxane, ethylhexylglycerin, disodium EDTA, trimethylsiloxysilicate, arachidyl glucoside, bisabolol, dipotassium glycyrrhizate, triethoxycaprylylsilane, BHT, polysorbate 60, stearic acid, methylisothiazolinone, polyaminopropyl biguanide, polymethyl methacrylate, tocopheryl acetate, ascorbic acid, pantothenic acid, retinyl palmitate, alumina

Questions?

Visit www.neutrogena.com or call toll-free 800-299-4786 or 215-273-8755 (collect)

Dist. by Neutrogena Corporation
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Neutrogena®

sensitive
skin

SUNSCREEN
Broad Spectrum SPF 60+
60+

pureSCREEN®
broad spectrum uva uvb

100% naturally sourced
sunscreen ingredients
fragrance free
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

3.0 FL OZ (88mL)

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label
NEUTROGENA SENSITIVE SKIN   SUNSCREEN BROAD SPECTRUM SPF60 PLUS
titanium dioxide and zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 10812-434
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide49 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide47 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Aluminum Oxide (UNII: LMI26O6933)  
Arachidyl Alcohol (UNII: 1QR1QRA9BU)  
Arachidyl Glucoside (UNII: 6JVW35JOOJ)  
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Yellow Wax (UNII: 2ZA36H0S2V)  
Docosanol (UNII: 9G1OE216XY)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Levomenol (UNII: 24WE03BX2T)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Dimethicone (UNII: 92RU3N3Y1O)  
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Isohexadecane (UNII: 918X1OUF1E)  
Methylisothiazolinone (UNII: 229D0E1QFA)  
Pantothenic Acid (UNII: 19F5HK2737)  
PEG-100 Stearate (UNII: YD01N1999R)  
Polyethylene Glycol 400 (UNII: B697894SGQ)  
PEG-8 Laurate (UNII: 762O8IWA10)  
Polihexanide (UNII: 322U039GMF)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Stearic Acid (UNII: 4ELV7Z65AP)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Trisiloxane (UNII: 9G1ZW13R0G)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10812-434-0188 mL in 1 TUBE; Type 0: Not a Combination Product01/01/201612/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35201/01/201612/01/2019
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 3/2018
 
Johnson & Johnson Consumer Inc.