Neutrogena® Ultra Sheer® SPF 55 and SPF 70 Suncare Kit

Neutrogena Ultra Sheer SPF 55 and SPF 70 Suncare Kit by

Drug Labeling and Warnings

Neutrogena Ultra Sheer SPF 55 and SPF 70 Suncare Kit by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NEUTROGENA ULTRA SHEER SPF 55 AND SPF 70 SUNCARE KIT - avobenzone, homosalate, octisalate, octocrylene, oxybenzone 
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® SPF 55 and SPF 70 Suncare Kit

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)

Neutrogena Ultra Sheer Face & Body Stick Sunscreen Broad Spectrum SPF 70

Drug Facts

Active ingredients

Avobenzone 3%
Homosalate 15%
Octisalate 5%
Octocrylene 10%
Oxybenzone 3%

Purpose

Sunscreen

Use

  • 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 and evenly 15 minutes before sun exposure
  • ensure complete coverage to the area above the lip, nose, and tops of ears.
  • reapply:
    • 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 value of SPF 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-sleeve 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

Adipic Acid/Diglycol Crosspolymer, Beeswax, BHT, C12-15 Alkyl Benzoate, Caprylyl Glycol, Diethylhexyl 2,6-Naphthalate, Fragrance, Neopentyl Glycol Diethylhexanoate, Neopentyl Glycol Diisostearate, Octyldodecyl Neopentanoate, Ozokerite, Paraffin, Polyethylene, Silica

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - Kit Carton

Neutrogena®

powerful sun protection,
unbelievably light feel

helioplex®
broad spectrum uvauvb

BEST OF BEAUTY
allure
THE BEAUTY EXPERT
2014
AWARD WINNER

INCLUDES
2014 Allure
Best of Beauty winner
ULTRA SHEER®
Face & Body Stick
Sunscreen Broad
Spectrum SPF 70
Net Wt. 1.5 OZ. (42 g)

#1 DERMATOLOGIST RECOMMENDED SUNCARE

ULTRA SHEER® SPF 55 3.0 FL. OZ. (88 mL) EACH, TOTAL 6.0 FL.OZ.(176 mL); ULTRA SHEER® SPF 70 NET WT.1.5 OZ. (42 g)

Principal Display Panel - Kit Carton
NEUTROGENA ULTRA SHEER SPF 55 AND SPF 70 SUNCARE KIT  
avobenzone, homosalate, octisalate, octocrylene, oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69968-0162
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69968-0162-91 in 1 CARTON02/02/201607/29/2018
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 88 mL
Part 21 CYLINDER 42 g
Part 1 of 2
NEUTROGENA ULTRA SHEER DRY TOUCH   SUNSCREEN BROAD SPECTRUM SPF55
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Item 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)  
Xanthan Gum (UNII: TTV12P4NEE)  
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)  
Water (UNII: 059QF0KO0R)  
Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10812-423-0188 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35209/01/2005
Part 2 of 2
NEUTROGENA ULTRA SHEER FACE AND BODY   SUNSCREEN BROAD SPECTRUM SPF70
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone stick
Product Information
Item Code (Source)NDC: 10812-419
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate150 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene100 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone30 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Yellow Wax (UNII: 2ZA36H0S2V)  
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)  
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)  
Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW)  
Octyldodecyl Neopentanoate (UNII: X8725R883T)  
Paraffin (UNII: I9O0E3H2ZE)  
High Density Polyethylene (UNII: UG00KM4WR7)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 10812-419-0242 g in 1 CYLINDER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35210/05/201310/26/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35202/02/201607/29/2018
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 12/2019