neutrogena ®

neutrogena ®
SPL v14
SPL
SPL Set ID c5a67314-e5b2-4dd6-94e9-39c2f286c346
Route
topical
Published
Effective Date 2025-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (150 mg) octisalate (50 mg) octocrylene (100 mg)
Inactive Ingredients
2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw) water butyloctyl salicylate butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer silicon dioxide dimethicone potassium cetyl phosphate benzyl alcohol yellow wax caprylyl trisiloxane aluminum starch octenylsuccinate glyceryl monostearate peg-100 stearate cetyl dimethicone 25 caprylyl glycol ethylhexylglycerin docosanol xanthan gum chlorphenesin dimethicone/peg-10/15 crosspolymer hydrolyzed jojoba esters (acid form) edetate disodium ethylhexyl stearate .alpha.-tocopherol acetate butylated hydroxytoluene jojoba oil, randomized trideceth-6

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-08-14

Description

Drug Facts


Medication Information

Warnings
  • For external use only
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
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, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Beeswax, Caprylyl Methicone, Aluminum Starch Octenylsuccinate, Glyceryl Stearate, PEG-100 Stearate, Cetyl Dimethicone, , Caprylyl Glycol, Ethylhexylglycerin, Behenyl Alcohol, Acrylates/Dimethicone Copolymer, Xanthan Gum, Chlorphenesin, Dimethicone/PEG-10/15 Crosspolymer, Sodium Polyacrylate, Hydrolyzed Jojoba Esters, Fragrance, Disodium EDTA, Ethylhexyl Stearate, Tocopheryl Acetate, BHT, Jojoba Esters, Trideceth-6

Description

Drug Facts

Questions?

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

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9
  • Stop use and ask a doctor if rash occurs
Section 50567-7
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1
  • Do not use on damaged or broken skin
Section 55105-1
Active ingredients Purpose
Avobenzone 3%) Sunscreen
Homosalate 15% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Principal Display Panel 88 Ml Tube Label

Neutrogena ®



DERMATOLOGIST RECOMMENED BRAND



Ultra Sheer ®



dry-touch



sunscreen



BROAD SPECTRUM SPF 70



70



helioplex ®



broad spectrum uva.uvb




lightweight clean feel



oxybenzone free



water resistant (80 minutes)



3.0 FL OZ (88 mL)


Structured Label Content

Warnings
  • For external use only
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
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 (Other information)
  • protect this product from excessive heat and direct sun
  • May stain some fabrics
Inactive Ingredients (Inactive ingredients)

Water, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Silica, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Beeswax, Caprylyl Methicone, Aluminum Starch Octenylsuccinate, Glyceryl Stearate, PEG-100 Stearate, Cetyl Dimethicone, , Caprylyl Glycol, Ethylhexylglycerin, Behenyl Alcohol, Acrylates/Dimethicone Copolymer, Xanthan Gum, Chlorphenesin, Dimethicone/PEG-10/15 Crosspolymer, Sodium Polyacrylate, Hydrolyzed Jojoba Esters, Fragrance, Disodium EDTA, Ethylhexyl Stearate, Tocopheryl Acetate, BHT, Jojoba Esters, Trideceth-6

Questions?

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9 (50566-9)
  • Stop use and ask a doctor if rash occurs
Section 50567-7 (50567-7)
  • When using this product keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
Section 55105-1 (55105-1)
Active ingredients Purpose
Avobenzone 3%) Sunscreen
Homosalate 15% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Principal Display Panel 88 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 88 mL Tube Label)

Neutrogena ®



DERMATOLOGIST RECOMMENED BRAND



Ultra Sheer ®



dry-touch



sunscreen



BROAD SPECTRUM SPF 70



70



helioplex ®



broad spectrum uva.uvb




lightweight clean feel



oxybenzone free



water resistant (80 minutes)



3.0 FL OZ (88 mL)


Advanced Ingredient Data


Raw Label Data

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