Neutrogena ®

Neutrogena ®
SPL v9
SPL
SPL Set ID ccc2e40b-5301-4055-8a89-47366687cfb7
Route
TOPICAL
Published
Effective Date 2020-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (15 mg) Homosalate (50 mg) Octisalate (40 mg) Octocrylene (60 mg)
Inactive Ingredients
Sodium Hydroxide Trideceth-6 Feverfew Fd&c Yellow No. 5 Fd&c Red No. 40 Polyurethane-62 Dimethicone Water Glycerin Diisopropyl Adipate Alcohol Silicon Dioxide Dicaprylyl Carbonate Caprylyl Trisiloxane Pentylene Glycol Hydroxyacetophenone 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Glyceryl Monostearate Phenoxyethanol Chlorphenesin Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) .alpha.-tocopherol Acetate Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-05

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 1.5%   Sunscreen
Homosalate 5%   Sunscreen
Octisalate 4%   Sunscreen
Octocrylene 6%   Sunscreen
Warnings

For external use only

Directions
  • apply liberally 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, Glycerin, Diisopropyl Adipate, Dimethicone, Alcohol Denat., Silica, Dicaprylyl Carbonate, Caprylyl Methicone, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Polyurethane-62, Pentylene Glycol, Hydroxyacetophenone, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Phenoxyethanol, Chlorphenesin, Dimethicone Crosspolymer, Fragrance, Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Trideceth-6, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Yellow 5, Red 40

Principal Display Panel 88 Ml Tube Label

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND



Invisible Daily



defense

lotion



sunscreen



BROAD SPECTRUM SPF 30



30



sun + environment



oxybenzone free



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 1.5%   Sunscreen
Homosalate 5%   Sunscreen
Octisalate 4%   Sunscreen
Octocrylene 6%   Sunscreen
Warnings

For external use only

Directions
  • apply liberally 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, Glycerin, Diisopropyl Adipate, Dimethicone, Alcohol Denat., Silica, Dicaprylyl Carbonate, Caprylyl Methicone, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Polyurethane-62, Pentylene Glycol, Hydroxyacetophenone, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Phenoxyethanol, Chlorphenesin, Dimethicone Crosspolymer, Fragrance, Tocopheryl Acetate, Disodium EDTA, Sodium Hydroxide, Trideceth-6, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Yellow 5, Red 40

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

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND



Invisible Daily



defense

lotion



sunscreen



BROAD SPECTRUM SPF 30



30



sun + environment



oxybenzone free



water resistant (80 minutes)



3.0 FL OZ (88 mL)


Advanced Ingredient Data


Raw Label Data

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