FDA.reportPublic FDA data

Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 50

Manufacturer
Kenvue Brands LLC
Effective date
2025-03-10
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:57:03

Label at a glance#

ProductNeutrogena Pure And Free Sunscreen Broad Spectrum SPF 50
Active ingredientZINC OXIDE
Label structure11 sections

Indications and 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

Dosage and administration

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...

Storage and handling

protect this product from excessive heat and direct sun may stain some fabrics package contains small parts, which could cause a choking hazard

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 21.6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • may stain some fabrics
  • package contains small parts, which could cause a choking hazard

Inactive ingredients

INACTIVE INGREDIENT SECTION

Octyldodecyl Neopentanoate, C12-15 Alkyl Benzoate, Synthetic Wax, Paraffin, Silica, Neopentyl Glycol Diethylhexanoate, Ozokerite, Isopropyl Myristate, Adipic Acid/Diglycol Crosspolymer, Triethoxycaprylylsilane, Neopentyl Glycol Diisostearate, Caprylyl Glycol, Avena Sativa (Oat) Kernel Oil

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC

Summit, NJ 0790

PRINCIPAL DISPLAY PANEL - 13 g Stick Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Neutrogena ®

Pure & Free ®

baby

zinc oxide
sunscreen stick

BROAD SPECTRUM
SPF 50

pureSCREEN ®

broad spectrum uva.uvb

ideal for delicate skin

water resistant
(80 minutes)

Neutrogena_1Neutrogena_1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0677-1Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 5013 g in 1 CANISTERSTICK139
69968-0677-1Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 501 in 1 BLISTER PACKSTICK19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0677NEUTROGENA PURE AND FREE SUNSCREEN BROAD SPECTRUM SPF 50 (ZINC OXIDE) STICK [KENVUE BRANDS LLC]9Current NDC, Legacy NDC, 2 package rows20250315_41ff1a98-69ff-4d7a-bc89-d986a803cee3.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-067769968-0677-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PARAFFINI9O0E3H2ZEIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
CERESINQ1LS2UJO3AIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S)R9TPS68K19IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
NEOPENTYL GLYCOL DIISOSTEARATE4M6OQ34JWWIACT
CAPRYLYL GLYCOL00YIU5438UIACT
OAT KERNEL OIL3UVP41R77RIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Pure And Free Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC41ff1a98-69ff-4d7a-bc89-d986a803cee32025-03-10WarningsExact identifier
ndc (package): 69968-0677-1
ndc (product): 69968-0677
ndc11 (package): 69968067701
spl id: 2ffd10e4-2c6b-4d04-e063-6394a90a023b
spl set id: 41ff1a98-69ff-4d7a-bc89-d986a803cee3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.