neutrogena ®

neutrogena ®
SPL v12
SPL
SPL Set ID 6a43173f-41f9-4207-a0db-53bc8db6f4a4
Route
topical
Published
Effective Date 2025-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
avobenzone (25 mg) homosalate (60 mg) octisalate (45 mg) octocrylene (80 mg)
Inactive Ingredients
dimethicone/peg-10/15 crosspolymer caprylyl glycol ethylhexylglycerin docosanol 2-ethylhexyl acrylate, methacrylate, methyl methacrylate, or butyl methacrylate/hydroxypropyl dimethicone copolymer (30000-300000 mw) xanthan gum chlorphenesin ethylhexyl stearate hydrolyzed jojoba esters (acid form) edetate disodium anhydrous .alpha.-tocopherol acetate butylated hydroxytoluene trideceth-6 jojoba oil, randomized silicon dioxide caprylyl trisiloxane diisopropyl adipate dimethicone potassium cetyl phosphate water benzyl alcohol yellow wax glyceryl monostearate peg-100 stearate cetyl dimethicone 25

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2019-10-07

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, Silica, Caprylyl Methicone, Diisopropyl Adipate, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Beeswax, Glyceryl Stearate, PEG-100 Stearate, Cetyl Dimethicone, Caprylyl Glycol, Ethylhexylglycerin, Behenyl Alcohol, Sodium Polyacrylate, Acrylates/Dimethicone Crosspolymer, Xanthan Gum, Chlorphenesin, Dimethicone/PEG-10/15 Crosspolymer, Ethylhexyl Stearate, Hydrolyzed Jojoba Esters, Fragrance, Disodium EDTA, Tocopheryl Acetate, BHT, Trideceth-6, Jojoba Esters

Description

Drug Facts

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 6% Sunscreen
Octisalate 4.5% Sunscreen
Octocrylene 8% Sunscreen
Questions Or Comments?

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

Principal Display Panel 88 Ml Tube Label

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

Ultra Sheer ®

dry-Touch

sunscreen

BROAD SPECTRUM SPF 30

30

helioplex ®

broad spectrum uva.uvb

lightweight clean feel

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, Silica, Caprylyl Methicone, Diisopropyl Adipate, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Beeswax, Glyceryl Stearate, PEG-100 Stearate, Cetyl Dimethicone, Caprylyl Glycol, Ethylhexylglycerin, Behenyl Alcohol, Sodium Polyacrylate, Acrylates/Dimethicone Crosspolymer, Xanthan Gum, Chlorphenesin, Dimethicone/PEG-10/15 Crosspolymer, Ethylhexyl Stearate, Hydrolyzed Jojoba Esters, Fragrance, Disodium EDTA, Tocopheryl Acetate, BHT, Trideceth-6, Jojoba Esters

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 6% Sunscreen
Octisalate 4.5% Sunscreen
Octocrylene 8% Sunscreen
Questions Or Comments? (Questions or Comments?)

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

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

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

Ultra Sheer ®

dry-Touch

sunscreen

BROAD SPECTRUM SPF 30

30

helioplex ®

broad spectrum uva.uvb

lightweight clean feel

oxybenzone free

water resistant (80 minutes)

3.0 FL OZ (88 mL)


Advanced Ingredient Data


Raw Label Data

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