NEUTROGENA ULTRA SHEER DRY TOUCH  SUNSCREEN BROAD SPECTRUM SPF 55- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone 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 Ultra Sheer Dry-Touch Sunscreen Broad Spectrum SPF 55

Drug Facts

Active ingredients

Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 2.8%, Oxybenzone 6%

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 liberally 15 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
  • protect from freezing
  • ship with winter protection
  • may stain some fabrics

Inactive ingredients

Butyloctyl salicylate, caprylyl Methicone, Behenyl Alcohol, VP/hexadecene copolymer, BHT, Methylparaben, trimethylsiloxysilicate, Propylparaben, Diethylhexyl 2,6-Naphthalate, Dimethicone, sodium polyacrylate, Disodium EDTA, Ethylhexyl Stearate, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Silica, Ethylparaben, Iodopropynyl butylcarbamate, Trideceth-6, Water, Xanthan Gum

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 147 mL Tube Label

VALUE-SIZE
Neutrogena®

Ultra Sheer®
DRY-TOUCH
SUNSCREEN
Broad Spectrum SPF 55

55

helioplex®
broad spectrum uva-uvb

LIGHTWEIGHT
CLEAN FEEL

fast absorbing
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

5 FL OZ (147 mL)

PRINCIPAL DISPLAY PANEL - 147 mL Tube Label
NEUTROGENA ULTRA SHEER DRY TOUCH   SUNSCREEN BROAD SPECTRUM SPF 55
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0391
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate100 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene28 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone60 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Butyloctyl salicylate (UNII: 2EH13UN8D3)  
DOCOSANOL (UNII: 9G1OE216XY)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
Methylparaben (UNII: A2I8C7HI9T)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
Propylparaben (UNII: Z8IX2SC1OH)  
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)  
Dimethicone (UNII: 92RU3N3Y1O)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Ethylhexyl Stearate (UNII: EG3PA2K3K5)  
Ethylhexylglycerin (UNII: 147D247K3P)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 Stearate (UNII: YD01N1999R)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ethylparaben (UNII: 14255EXE39)  
Iodopropynyl butylcarbamate (UNII: 603P14DHEB)  
Trideceth-6 (UNII: 3T5PCR2H0C)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69968-0391-5147 mL in 1 TUBE; Type 0: Not a Combination Product10/01/201812/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/01/201812/29/2020
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2020
Document Id: 3b8d26e4-e80d-401f-80f7-36bc54364ad7
Set id: 6ef7d10d-16b2-4f77-9348-e66831c8353f
Version: 2
Effective Time: 20201002
 
Johnson & Johnson Consumer Inc.