neutrogena ®

neutrogena ®
SPL v11
SPL
SPL Set ID e4a2e6e4-5c35-4178-b341-65644233b7b8
Route
topical
Published
Effective Date 2025-03-17
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
dimethicone/peg-10/15 crosspolymer synthetic beeswax benzyl alcohol butyloctyl salicylate butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer potassium cetyl phosphate silicon dioxide glyceryl monostearate peg-100 stearate dimethicone caprylyl glycol ethylhexylglycerin docosanol xanthan gum water chlorphenesin hydrolyzed jojoba esters (acid form) edetate disodium ethylhexyl stearate butylated hydroxytoluene jojoba oil, randomized trideceth-6

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-10-07
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 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, Potassium Cetyl Phosphate, Benzyl Alcohol, Silica, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Caprylyl Glycol, Synthetic Beeswax, Ethylhexylglycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Fragrance, Xanthan Gum, Chlorphenesin, Dimethicone/PEG-10/15 Crosspolymer, Hydrolyzed Jojoba Esters, Disodium EDTA, Sodium Polyacrylate, Ethylhexyl Stearate, BHT, Jojoba Esters, Trideceth-6

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 198 Ml Bottle Label

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND

Beach



Defense ®



water + sun



protection

sunscreen lotion



BROAD SPECTRUM SPF 50

50

helioplex ®



broad spectrum uva●uvb

oxybenzone free



water resistant (80 minutes)

6.7 FL OZ (198 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 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, Potassium Cetyl Phosphate, Benzyl Alcohol, Silica, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Caprylyl Glycol, Synthetic Beeswax, Ethylhexylglycerin, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Behenyl Alcohol, Fragrance, Xanthan Gum, Chlorphenesin, Dimethicone/PEG-10/15 Crosspolymer, Hydrolyzed Jojoba Esters, Disodium EDTA, Sodium Polyacrylate, Ethylhexyl Stearate, BHT, Jojoba Esters, Trideceth-6

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 198 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 198 mL Bottle Label)

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND

Beach



Defense ®



water + sun



protection

sunscreen lotion



BROAD SPECTRUM SPF 50

50

helioplex ®



broad spectrum uva●uvb

oxybenzone free



water resistant (80 minutes)

6.7 FL OZ (198 mL)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:06:51.630405 · Updated: 2026-03-14T23:09:53.979552