NEUTROGENA ULTRA SHEER DRY TOUCH  SUNSCREEN BROAD SPECTRUM SPF55- 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
  • may stain some fabrics

Inactive ingredients

water, butyloctyl salicylate, styrene/acrylates copolymer, silica, diethylhexyl 2,6-naphthalate, VP/hexadecene copolymer, dimethicone, caprylyl methicone, phenoxyethanol, ethylhexylglycerin, glyceryl stearate, PEG-100 stearate, trimethylsiloxysilicate, sodium polyacrylate, methylparaben, behenyl alcohol, xanthan gum, propylparaben, ethylparaben, fragrance, disodium EDTA, BHT, iodopropynyl butylcarbamate

Questions?

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

Dist. by Neutrogena Corp., Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

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

3.0 FL OZ (88 mL)

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label
NEUTROGENA ULTRA SHEER DRY TOUCH   SUNSCREEN BROAD SPECTRUM SPF55
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10812-423
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
Docosanol (UNII: 9G1OE216XY)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)  
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)  
Dimethicone (UNII: 92RU3N3Y1O)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Ethylparaben (UNII: 14255EXE39)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
Methylparaben (UNII: A2I8C7HI9T)  
PEG-100 Stearate (UNII: YD01N1999R)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
Water (UNII: 059QF0KO0R)  
Xanthan Gum (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10812-423-0188 mL in 1 TUBE; Type 0: Not a Combination Product09/01/200503/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/200503/01/2022
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 10/2020
Document Id: 0dc8bf67-570d-43b8-8fc1-af84030f758e
Set id: 2078cfda-d079-47e7-aabc-c0397b8d5447
Version: 4
Effective Time: 20201012
 
Johnson & Johnson Consumer Inc.