Neutrogena ®

Neutrogena ®
SPL v7
SPL
SPL Set ID c358745d-b9c0-4a9e-9a83-caffa04ea2e5
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
Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer Potassium Cetyl Phosphate Benzyl Alcohol Silicon Dioxide Glyceryl Monostearate Peg-100 Stearate Dimethicone Caprylyl Glycol Synthetic Beeswax 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 Water Butyloctyl Salicylate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-12-06

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
Questions?

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

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

Principal Display Panel 250 Ml Bottle Label

VALUE SIZE



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)



8.5 FL OZ (250 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
Questions?

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

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

Principal Display Panel 250 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label)

VALUE SIZE



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)



8.5 FL OZ (250 mL)


Advanced Ingredient Data


Raw Label Data

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