Neutrogena ®

Neutrogena ®
SPL v8
SPL
SPL Set ID 2d2c58e2-0d15-4383-adae-12fc17b8ea50
Route
TOPICAL
Published
Effective Date 2025-03-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (216 mg)
Inactive Ingredients
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 Ethyl Methicone (8 Mpa.s) Ethylhexylglycerin Glycerin Polyhydroxystearic Acid (2300 Mw) Caprylyl Glycol Cetyl Dimethicone/bis-vinyldimethicone Crosspolymer Phenylethyl Alcohol Phenoxyethanol Silicon Dioxide Cetyl Dimethicone 25 Triethoxycaprylylsilane Glyceryl Monobehenate Sodium Chloride Chlorphenesin Feverfew 2-ethylhexyl Acrylate, Methacrylate, Methyl Methacrylate, Or Butyl Methacrylate/hydroxypropyl Dimethicone Copolymer (30000-300000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-10-01

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 value of SPF 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
Active Ingredient

Zinc Oxide 21.6%

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

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 ®



pure & free ®



baby



SUNSCREEN



Broad Spectrum SPF 50



50



pureSCREEN ®



100% zinc oxide active uva.uvb



ACCEPTED



e



NATIONALECZEMA.ORG



NATIONAL



ECZEMA



ASSOCIATION

TEAR FREE



fragrance free



water resistant



(80 minutes)

#1 DERMATOLOGIST



RECOMMENDED SUNCARE

3.0 FL OZ (88mL)


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 value of SPF 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
Active Ingredient (Active ingredient)

Zinc Oxide 21.6%

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 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 ®



pure & free ®



baby



SUNSCREEN



Broad Spectrum SPF 50



50



pureSCREEN ®



100% zinc oxide active uva.uvb



ACCEPTED



e



NATIONALECZEMA.ORG



NATIONAL



ECZEMA



ASSOCIATION

TEAR FREE



fragrance free



water resistant



(80 minutes)

#1 DERMATOLOGIST



RECOMMENDED SUNCARE

3.0 FL OZ (88mL)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)