neutrogena ®

neutrogena ®
SPL v10
SPL
SPL Set ID b043f0f3-b263-4c49-86ca-9ecc71a22aa8
Route
topical
Published
Effective Date 2022-07-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (30 mg) homosalate (135 mg) octisalate (50 mg) octocrylene (100 mg)
Inactive Ingredients
2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw) water butyloctyl salicylate glycerin alcohol silicon dioxide dimethicone aluminum starch octenylsuccinate phenoxyethanol pentylene glycol butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer glyceryl monostearate .alpha.-tocopherol acetate chlorphenesin ginger menthyl lactate, (-)- edetate disodium anhydrous trideceth-6 feverfew sodium hydroxide fd&c yellow no. 5 fd&c red no. 40 polyurethane-62

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-10-05 Until 2026-12-26

Description

Drug Facts


Medication Information

Warnings

For external use only

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

Water, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Dimethicone, Aluminum Starch Octenylsuccinate, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Chlorphenesin, Styrene/Acrylates Copolymer, Zingiber Officinale (Ginger) Root Extract, Menthyl Lactate, Tocopheryl Acetate, Disodium EDTA, Trideceth-6, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Sodium Hydroxide, Yellow 5, Red 40

Description

Drug Facts

Questions?

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

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 13.5% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Principal Display Panel 50 Ml Bottle Carton

Neutrogena ®



DERMATOLOGIST



RECOMMENDED BRAND

Invisible Daily



defense

face serum



sunscreen

BROAD SPECTRUM



SPF 60+



60+

sun + environment



oxybenzone free

water resistant (80 minutes)



1.7 FL OZ (50 mL)


Structured Label Content

Warnings

For external use only

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

Water, Butyloctyl Salicylate, Glycerin, Alcohol Denat., Silica, Dimethicone, Aluminum Starch Octenylsuccinate, Polyurethane-62, Phenoxyethanol, Pentylene Glycol, Sodium Acryloyldimethyltaurate/VP Crosspolymer, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, Chlorphenesin, Styrene/Acrylates Copolymer, Zingiber Officinale (Ginger) Root Extract, Menthyl Lactate, Tocopheryl Acetate, Disodium EDTA, Trideceth-6, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Sodium Hydroxide, Yellow 5, Red 40

Questions?

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

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 13.5% Sunscreen
Octisalate 5% Sunscreen
Octocrylene 10% Sunscreen
Principal Display Panel 50 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton)

Neutrogena ®



DERMATOLOGIST



RECOMMENDED BRAND

Invisible Daily



defense

face serum



sunscreen

BROAD SPECTRUM



SPF 60+



60+

sun + environment



oxybenzone free

water resistant (80 minutes)



1.7 FL OZ (50 mL)


Advanced Ingredient Data


Raw Label Data

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