Neutrogena ®

Neutrogena ®
SPL v10
SPL
SPL Set ID 57f91218-2477-4495-98e8-c512d823e158
Route
TOPICAL
Published
Effective Date 2025-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (150 mg) Octisalate (50 mg) Octocrylene (100 mg) Avobenzone (30 mg)
Inactive Ingredients
Synthetic Beeswax Water Butyloctyl Salicylate Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer Potassium Cetyl Phosphate Benzyl Alcohol Silicon Dioxide Glyceryl Monostearate Peg-100 Stearate Dimethicone Caprylyl Glycol Ethylhexylglycerin Docosanol Xanthan Gum Chlorphenesin Dimethicone/peg-10/15 Crosspolymer 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 2020-10-05

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

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
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
Active Ingredients

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

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 70



70

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
Purpose

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
Active Ingredients (Active ingredients)

Avobenzone 3%, Homosalate 15%, Octisalate 5%, Octocrylene 10%

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 70



70

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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