neutrogena ®

neutrogena ®
SPL v11
SPL
SPL Set ID 525f7bae-44b8-44e4-93ea-32995eca2566
Route
topical
Published
Effective Date 2025-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (216 mg)
Inactive Ingredients
cetyl dimethicone 25 triethoxycaprylylsilane phenoxyethanol glyceryl dibehenate sodium chloride chlorphenesin phenylethyl alcohol caprylyl glycol cetyl dimethicone/bis-vinyldimethicone crosspolymer feverfew water alkyl (c12-15) benzoate butyl methacrylate/methyl methacrylate/methacrylic acid/styrene crosspolymer octyldodecyl citrate crosspolymer phenyl trimethicone cetyl peg/ppg-10/1 dimethicone (hlb 5) dimethicone glycerin polyhydroxystearic acid (2300 mw) ethyl methicone (8 mpa.s) silicon dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2020-01-31 Until 2022-11-01

Purpose

Sunscreen

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
Purpose

Sunscreen

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, C12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Octyldodecyl Citrate Crosspolymer, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Glycerin, Polyhydroxystearic Acid, Ethyl Methicone, Silica, Cetyl Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Glyceryl Behenate, Sodium Chloride, Acrylates/Dimethicone Copolymer, Chlorphenesin, Phenethyl Alcohol, Caprylyl Glycol, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice

Description

Drug Facts

Questions?

Call toll-free 800-299-4786 or 215-273-8755 (collect). 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
Active Ingredient

Zinc Oxide (21.6%)

Principal Display Panel 88 Ml Tube Label

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND



Sheer Zinc



mineral

sunscreen



BROAD SPECTRUM SPF 50



50

100% mineral active



hypoallergenic



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
Purpose

Sunscreen

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, C12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Octyldodecyl Citrate Crosspolymer, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Glycerin, Polyhydroxystearic Acid, Ethyl Methicone, Silica, Cetyl Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Glyceryl Behenate, Sodium Chloride, Acrylates/Dimethicone Copolymer, Chlorphenesin, Phenethyl Alcohol, Caprylyl Glycol, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice

Questions?

Call toll-free 800-299-4786 or 215-273-8755 (collect). 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
Active Ingredient (Active ingredient)

Zinc Oxide (21.6%)

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

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND



Sheer Zinc



mineral

sunscreen



BROAD SPECTRUM SPF 50



50

100% mineral active



hypoallergenic



water resistant (80 minutes)

3.0 FL OZ (88 mL)


Advanced Ingredient Data


Raw Label Data

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