FDA.reportPublic FDA data

Neutrogena pure and free baby

Manufacturer
Kenvue Brands LLC
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:57:35

Label at a glance#

ProductNeutrogena pure and free baby 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 value of SPF 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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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 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

Other information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:

Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Neutrogena_1Neutrogena_1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0275-3Neutrogena pure and free babySUNSCREEN Broad Spectrum SPF 5088 mL in 1 TUBELOTION888

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0275NEUTROGENA PURE AND FREE BABY SUNSCREEN BROAD SPECTRUM SPF 50 (ZINC OXIDE) LOTION [KENVUE BRANDS LLC]8Current NDC, Legacy NDC, 1 package rows20250323_2d2c58e2-0d15-4383-adae-12fc17b8ea50.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-027569968-0275-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
OCTYLDODECYL CITRATE CROSSPOLYMERX323T6QO4MIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
DIMETHICONE92RU3N3Y1OIACT
ETHYL METHICONE (8 MPA.S)3YWG8XYT8HIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMERAE7QA6TW0QIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
GLYCERYL MONOBEHENATEA626UU0W2AIACT
SODIUM CHLORIDE451W47IQ8XIACT
CHLORPHENESINI670DAL4SZIACT
FEVERFEWZ64FK7P217IACT
ZINC OXIDESOI2LOH54ZACTIB
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW)S7ZA3CCJ4MIACT

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 baby SUNSCREEN Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC2d2c58e2-0d15-4383-adae-12fc17b8ea502025-03-20WarningsExact identifier
ndc (package): 69968-0275-3
ndc (product): 69968-0275
ndc11 (package): 69968027503
spl id: 30c46608-e9a1-a313-e063-6394a90a8a86
spl set id: 2d2c58e2-0d15-4383-adae-12fc17b8ea50

Reported adverse events (FAERS/openFDA)#

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