neutrogena ®

neutrogena ®
SPL v5
SPL
SPL Set ID bfb1fdbe-883f-4d1d-9131-a46da9827788
Route
topical
Published
Effective Date 2024-01-18
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
butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer silicon dioxide dimethicone potassium cetyl phosphate benzyl alcohol yellow wax caprylyl trisiloxane glyceryl monostearate peg-100 stearate caprylyl glycol ethylhexylglycerin aluminum starch octenylsuccinate docosanol xanthan gum chlorphenesin hydrolyzed jojoba esters (acid form) edetate disodium anhydrous ethylhexyl stearate .alpha.-tocopherol acetate butylated hydroxytoluene trideceth-6 jojoba oil, randomized cetyl dimethicone 25 dimethicone/peg-10/15 crosspolymer water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-10-07
How Supplied

Product: 50090-6558 NDC: 50090-6558-0 88 mL in a TUBE / 12 in a CARTON

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

How Supplied

Product: 50090-6558

NDC: 50090-6558-0 88 mL in a TUBE / 12 in a CARTON

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 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Avobenzone, Homosalate, Octisalate, and Octocrylene Lotion

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

How Supplied (HOW SUPPLIED)

Product: 50090-6558

NDC: 50090-6558-0 88 mL in a TUBE / 12 in a CARTON

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 10% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Avobenzone, Homosalate, Octisalate, and Octocrylene Lotion (avobenzone, homosalate, octisalate, and octocrylene lotion)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:43.440484 · Updated: 2026-03-14T23:02:25.522673