neutrogena ®

neutrogena ®
SPL v10
SPL
SPL Set ID 7f60d6bd-1735-4390-bc8a-e3876ab7ad50
Route
topical
Published
Effective Date 2025-04-24
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
hyaluronic acid polyurethane-62 glycerin alcohol butyloctyl salicylate silicon dioxide caprylyl trisiloxane aluminum starch octenylsuccinate dimethicone phenoxyethanol pentylene glycol butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer glyceryl monostearate chlorphenesin menthyl lactate, (-)- .alpha.-tocopherol acetate edetate disodium trideceth-6 sodium hydroxide fd&c blue no. 1 water 2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-10-01

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
  • protect from freezing
  • May stain some fabrics
Inactive Ingredients

Water, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Caprylyl Methicone, Aluminum Starch Octenylsuccinate, Dimethicone, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Styrene/Acrylates Copolymer, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Fragrance, Glyceryl Stearate, Chlorphenesin, Menthyl Lactate, Tocopheryl Acetate, Disodium EDTA, Trideceth-6, Hydrolyzed Hyaluronic Acid, Sodium Hydroxide, Blue 1

Description

Drug Facts

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
Questions Or Comments?

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

Principal Display Panel 88 Ml Tube Label

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND



Hydro



Boost




water gel lotion



sunscreen



BROAD SPECTRUM SPF 50



50



helioplex ®



broad spectrum uva.uvb



invisible finish



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
  • protect from freezing
  • May stain some fabrics
Inactive Ingredients (Inactive ingredients)

Water, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Caprylyl Methicone, Aluminum Starch Octenylsuccinate, Dimethicone, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Styrene/Acrylates Copolymer, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Fragrance, Glyceryl Stearate, Chlorphenesin, Menthyl Lactate, Tocopheryl Acetate, Disodium EDTA, Trideceth-6, Hydrolyzed Hyaluronic Acid, Sodium Hydroxide, Blue 1

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
Questions Or Comments? (Questions or comments?)

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

Principal Display Panel 88 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 88 mL Tube Label)

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND



Hydro



Boost




water gel lotion



sunscreen



BROAD SPECTRUM SPF 50



50



helioplex ®



broad spectrum uva.uvb



invisible finish



oxybenzone free



water resistant (80 minutes)



3.0 FL OZ (88 mL)


Advanced Ingredient Data


Raw Label Data

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