Neutrogena ®

Neutrogena ®
SPL v9
SPL
SPL Set ID 3e25a4ce-dbdd-4830-a3d8-a2dfb3bcb078
Route
TOPICAL
Published
Effective Date 2020-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (27 mg) Homosalate (40 mg) Octisalate (45 mg) Octocrylene (60 mg) Oxybenzone
Inactive Ingredients
Water Silicon Dioxide Cetyl Dimethicone 25 Alkyl (c12-15) Benzoate Steareth-100 Ethylhexylglycerin Phenoxyethanol Caprylyl Glycol Dimethicone Steareth-2 Polyester-7 Chlorphenesin Propylene Glycol Ethylhexyl Stearate Neopentyl Glycol Diheptanoate Levomenol Edetate Disodium Anhydrous Butylene Glycol Butyl Methacrylate/methyl Methacrylate/methacrylic Acid/styrene Crosspolymer Diethylhexyl 2,6-naphthalate Yeast Mannan Xanthan Gum Butylated Hydroxytoluene Capryloyl Glycine Trideceth-6 Sarcosine Cedrus Atlantica Bark Cinnamon Bark Oil Purslane

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 2.7% Sunscreen
Homosalate 4% Sunscreen
Octisalate 4.5% Sunscreen
Octocrylene 6% Sunscreen
Oxybenzone 4.5% Sunscreen
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 800-582-4048 or 215-273-8755 (collect). www.neutrogena.com

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, Steareth-100, Ethylhexylglycerin, Phenoxyethanol, Caprylyl Glycol, Sodium Polyacrylate, Dimethicone, Steareth-2, Polyester-7, Chlorphenesin, Propylene Glycol, Ethylhexyl Stearate, Neopentyl Glycol Diheptanoate, Bisabolol, Disodium EDTA, Butylene Glycol, Acrylates/Dimethicone Copolymer, Diethylhexyl 2,6-Naphthalate, Mannan, Xanthan Gum, BHT, Capryloyl Glycine, Trideceth-6, Sarcosine, Cedrus Atlantica Bark Extract, Cinnamomum Zeylanicum Bark Extract, Portulaca Oleracea Extract

Principal Display Panel 88 Ml Tube Label

Neutrogena ®

#1 DERMATOLOGIST RECOMMENDED BRAND

Clear Face

BREAKOUT FREE

oil-free

sunscreen

BROAD SPECTRUM SPF 55

55

helioplex ®

broad spectrum uva•uvb

won't cause breakouts

ultra-light

water resistant (80 minutes)

3.0 FL OZ (88 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 2.7% Sunscreen
Homosalate 4% Sunscreen
Octisalate 4.5% Sunscreen
Octocrylene 6% Sunscreen
Oxybenzone 4.5% Sunscreen
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 800-582-4048 or 215-273-8755 (collect). www.neutrogena.com

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, Steareth-100, Ethylhexylglycerin, Phenoxyethanol, Caprylyl Glycol, Sodium Polyacrylate, Dimethicone, Steareth-2, Polyester-7, Chlorphenesin, Propylene Glycol, Ethylhexyl Stearate, Neopentyl Glycol Diheptanoate, Bisabolol, Disodium EDTA, Butylene Glycol, Acrylates/Dimethicone Copolymer, Diethylhexyl 2,6-Naphthalate, Mannan, Xanthan Gum, BHT, Capryloyl Glycine, Trideceth-6, Sarcosine, Cedrus Atlantica Bark Extract, Cinnamomum Zeylanicum Bark Extract, Portulaca Oleracea Extract

Principal Display Panel 88 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 88 mL Tube Label)

Neutrogena ®

#1 DERMATOLOGIST RECOMMENDED BRAND

Clear Face

BREAKOUT FREE

oil-free

sunscreen

BROAD SPECTRUM SPF 55

55

helioplex ®

broad spectrum uva•uvb

won't cause breakouts

ultra-light

water resistant (80 minutes)

3.0 FL OZ (88 mL)


Advanced Ingredient Data


Raw Label Data

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