Neutrogena ®

Neutrogena ®
SPL v12
SPL
SPL Set ID 32889c1e-d539-4b36-b012-9789c4a8d642
Route
TOPICAL
Published
Effective Date 2023-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (25 mg) Homosalate (80 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Water Silicon Dioxide Cetyl Dimethicone 25 Alkyl (c12-15) Benzoate Ethylhexylglycerin Steareth-100 Aluminum Starch Octenylsuccinate Phenoxyethanol Caprylyl Glycol Dimethicone Polyester-7 Chlorphenesin Steareth-2 Ethylhexyl Stearate Edetate Disodium Anhydrous Propylene Glycol Neopentyl Glycol Diheptanoate Levomenol Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer Butylene Glycol Butylated Hydroxytoluene Yeast Mannan Xanthan Gum Capryloyl Glycine Trideceth-6 Sarcosine Cedrus Atlantica Bark Cinnamon Bark Oil Purslane

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-10-07 Until 2026-12-14

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 2.5% Sunscreen
Homosalate 8% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 8% Sunscreen
Warnings
  • For external use only
Directions
  • apply generously and evenly 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?

Visit www.neutrogena.com or call toll‐free 800-299-4786 or 215‐273‐8755 (collect)

Other Information
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Inactive Ingredients

Water, Silica, Cetyl Dimethicone, Styrene/Acrylates Copolymer, C12-15 Alkyl Benzoate, Ethylhexylglycerin, Steareth-100, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Caprylyl, Glycol, Sodium Polyacrylate, Dimethicone, Polyester-7, Chlorphenesin, Steareth-2, Ethylhexyl Stearate, Disodium EDTA, Propylene Glycol, Neopentyl Glycol Diheptanoate, Bisabolol, Acrylates/Dimethicone Copolymer, Butylene Glycol, BHT, Mannan, Xanthan Gum, Capryloyl, Glycine, Trideceth-6, Sarcosine, Cedrus Atlantica Bark Extract, Cinnamomum Zeylanicum Bark Extract, Portulaca Oleracea Extract

Principal Display Panel 147 Ml Tube Label

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND

Clear Body



BREAKOUT FREE



oil-free



sunscreen



BROAD SPECTRUM SPF 30

30

helioplex ®



broad spectrum uva•uvb

won't cause breakouts



oxybenzone free

water resistant (80 minutes)

5.0 FL OZ (147 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 2.5% Sunscreen
Homosalate 8% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 8% Sunscreen
Warnings
  • For external use only
Directions
  • apply generously and evenly 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?

Visit www.neutrogena.com or call toll‐free 800-299-4786 or 215‐273‐8755 (collect)

Other Information (Other information)
  • protect this product from excessive heat and direct sun
  • may stain some fabrics
Inactive Ingredients (Inactive ingredients)

Water, Silica, Cetyl Dimethicone, Styrene/Acrylates Copolymer, C12-15 Alkyl Benzoate, Ethylhexylglycerin, Steareth-100, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Caprylyl, Glycol, Sodium Polyacrylate, Dimethicone, Polyester-7, Chlorphenesin, Steareth-2, Ethylhexyl Stearate, Disodium EDTA, Propylene Glycol, Neopentyl Glycol Diheptanoate, Bisabolol, Acrylates/Dimethicone Copolymer, Butylene Glycol, BHT, Mannan, Xanthan Gum, Capryloyl, Glycine, Trideceth-6, Sarcosine, Cedrus Atlantica Bark Extract, Cinnamomum Zeylanicum Bark Extract, Portulaca Oleracea Extract

Principal Display Panel 147 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 147 mL Tube Label)

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND

Clear Body



BREAKOUT FREE



oil-free



sunscreen



BROAD SPECTRUM SPF 30

30

helioplex ®



broad spectrum uva•uvb

won't cause breakouts



oxybenzone free

water resistant (80 minutes)

5.0 FL OZ (147 mL)


Advanced Ingredient Data


Raw Label Data

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