neutrogena ®

neutrogena ®
SPL v14
SPL
SPL Set ID 10ca67ca-c372-44a9-8933-84cce9fb9934
Route
topical
Published
Effective Date 2025-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (100 mg) octisalate (50 mg) octocrylene
Inactive Ingredients
silicon dioxide cetyl dimethicone 25 butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer alkyl (c12-15) benzoate water steareth-100 ethylhexylglycerin aluminum starch octenylsuccinate phenoxyethanol caprylyl glycol dimethicone steareth-2 polyester-7 chlorphenesin ethylhexyl stearate edetate disodium propylene glycol neopentyl glycol diheptanoate levomenol butylene glycol yeast mannan xanthan gum butylated hydroxytoluene capryloyl glycine cinnamon bark oil trideceth-6 cedrus atlantica bark sarcosine purslane 2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-10-05

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 generously and evenly 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, Silica, Cetyl Dimethicone, Styrene/Acrylates Copolymer, C12-15 Alkyl Benzoate, Steareth-100, Ethylhexylglycerin, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Caprylyl Glycol, Sodium Polyacrylate, Dimethicone, Steareth-2, Polyester-7, Chlorphenesin, Ethylhexyl Stearate, Disodium EDTA, Propylene Glycol, Neopentyl Glycol Diheptanoate, Bisabolol, Acrylates/Dimethicone Copolymer, Butylene Glycol, Mannan, Xanthan Gum, BHT, Capryloyl Glycine, Trideceth-6, Sarcosine, Cedrus Atlantica Bark Extract, Cinnamomum Zeylanicum Bark Extract, Portulaca Oleracea Extract

Description

Drug Facts

Questions?

Call toll-free 800-582-4048 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 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Principal Display Panel 88 Ml Tube Label

Neutrogena ®

DERMATOLOGIST RECOMMENED BRAND

Clear Face

BREAKOUT FREE

oil-free



sunscreen



BROAD SPECTRUM SPF 50

50

helioplex ®



broad spectrum uva.uvb

won't cause breakouts



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 generously and evenly 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, Silica, Cetyl Dimethicone, Styrene/Acrylates Copolymer, C12-15 Alkyl Benzoate, Steareth-100, Ethylhexylglycerin, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Caprylyl Glycol, Sodium Polyacrylate, Dimethicone, Steareth-2, Polyester-7, Chlorphenesin, Ethylhexyl Stearate, Disodium EDTA, Propylene Glycol, Neopentyl Glycol Diheptanoate, Bisabolol, Acrylates/Dimethicone Copolymer, Butylene Glycol, Mannan, Xanthan Gum, BHT, Capryloyl Glycine, Trideceth-6, Sarcosine, Cedrus Atlantica Bark Extract, Cinnamomum Zeylanicum Bark Extract, Portulaca Oleracea Extract

Questions?

Call toll-free 800-582-4048 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 10% 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

Clear Face

BREAKOUT FREE

oil-free



sunscreen



BROAD SPECTRUM SPF 50

50

helioplex ®



broad spectrum uva.uvb

won't cause breakouts



oxybenzone free



water resistant (80 minutes)

3.0 FL OZ (88 mL)


Advanced Ingredient Data


Raw Label Data

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