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

Description

Drug Facts

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
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
Warnings
  • For external use only
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

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

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
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
Warnings
  • For external use only
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

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

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