neutrogena ®

neutrogena ®
SPL v11
SPL
SPL Set ID 1390f863-709e-412b-9a25-b65217844e44
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
water butyloctyl salicylate glycerin alcohol silicon dioxide dimethicone aluminum starch octenylsuccinate phenoxyethanol pentylene glycol butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer glyceryl monostearate chlorphenesin menthyl lactate, (-)- .alpha.-tocopherol acetate edetate disodium trideceth-6 feverfew sodium hydroxide fd&c yellow no. 5 fd&c red no. 40 polyurethane-62 2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2020-10-05

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, fragrance, 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 88 Ml Tube Label

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND

Invisible Daily



defense



lotion

sunscreen



BROAD SPECTRUM SPF 60+



60+

sun + environment



oxybenzone free



water resistant (80 minutes)

3.0 FL OZ (88 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, fragrance, 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 88 Ml Tube Label (PRINCIPAL DISPLAY PANEL - 88 mL Tube Label)

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND

Invisible Daily



defense



lotion

sunscreen



BROAD SPECTRUM SPF 60+



60+

sun + environment



oxybenzone free



water resistant (80 minutes)

3.0 FL OZ (88 mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)