Neutrogena ®

Neutrogena ®
SPL v8
SPL
SPL Set ID c914c4cd-99a2-4d9f-8f04-8af2ace3c345
Route
TOPICAL
Published
Effective Date 2025-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (216 mg)
Inactive Ingredients
2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw) Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Dimethicone Glycerin Polyhydroxystearic Acid (2300 Mw) Ethyl Methicone (8 Mpa.s) Silicon Dioxide 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-01

Description

Drug Facts

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

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

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). www.neutrogena.com

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

Zinc Oxide 21.6%

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

Principal Display Panel 88 Ml Tube Label

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND




Sheer Zinc

kids



mineral



sunscreen

BROAD SPECTRUM SPF 50+

50+



TEAR FREE



free of fragrance,



parabens, and dyes



water resistant (80minutes)

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

Purpose

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). www.neutrogena.com

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

Zinc Oxide 21.6%

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

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

Neutrogena ®



DERMATOLOGIST RECOMMENDED BRAND




Sheer Zinc

kids



mineral



sunscreen

BROAD SPECTRUM SPF 50+

50+



TEAR FREE



free of fragrance,



parabens, and dyes



water resistant (80minutes)

3.0 FL OZ. (88 mL)


Advanced Ingredient Data


Raw Label Data

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