FDA.reportPublic FDA data

Aveeno Baby continuous protection sensitive skin

Manufacturer
Kenvue Brands LLC
Effective date
2025-03-04
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 00:56:45

Label at a glance#

ProductAveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50
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, C 12-15 Alkyl Benzoate, Styrene/Acrylates Copolymer, Octyldodecyl Citrate Crosspolymer, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Polyhydroxystearic Acid, Glycerin, Ethyl Methicone, Silica, Cetyl Dimethicone, Triethoxycaprylylsilane, Phenoxyethanol, Glyceryl Behenate, Sodium Chloride, Acrylates/Dimethicone Copolymer, Chlorphenesin, Phenethyl Alcohol, Avena Sativa (Oat) Kernel Flour, Caprylyl Glycol, Cetyl Dimethicone/Bis-Vinyldimethicone Crosspolymer, Chrysanthemum Parthenium (Feverfew)Flower/Leaf/Stem Juice

Questions

OTC - QUESTIONS SECTION

866-428-3366; Outside US , dial collect 215-273-8755 www.aveeno.com

SPL UNCLASSIFIED SECTION

Distributed by:
Kenvue Brands LLC
Summit, NJ 07901

PRINCIPAL DISPLAY PANEL - 207 mL Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PEDIATRICIAN

RECOMMENDED BRAND

Aveeno

Baby ®

CONTINUOUS

PROTECTION ®

sensitive skin

zinc oxide

sunscreen

BROAD SPECTRUM SPF 50

naturally-sourced 100%

mineral active ingredient

sweat + water resistant

(80 min)

SPF

50

3.0 fl oz (88 mL)

Aveeno_1Aveeno_1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0304-1Aveeno Baby continuous protection sensitive skinSunscreen Broad Spectrum SPF5014 mL in 1 TUBELOTION1410
69968-0304-3Aveeno Baby continuous protection sensitive skinSunscreen Broad Spectrum SPF5088 mL in 1 TUBELOTION8810
69968-0304-6Aveeno Baby continuous protection sensitive skinSunscreen Broad Spectrum SPF502 in 1 TRAYLOTION210
69968-0304-7Aveeno Baby continuous protection sensitive skinSunscreen Broad Spectrum SPF50207 mL in 1 TUBELOTION20710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0304AVEENO BABY CONTINUOUS PROTECTION SENSITIVE SKIN SUNSCREEN BROAD SPECTRUM SPF50 (ZINC OXIDE) LOTION [KENVUE BRANDS LLC]10Current NDC, Legacy NDC, 4 package rows20250308_bbd6710f-a665-437e-b86b-437f732984d1.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-030469968-0304-1, 69968-0304-3, 69968-0304-6, 69968-0304-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
DIMETHICONE92RU3N3Y1OIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
GLYCERINPDC6A3C0OXIACT
ETHYL METHICONE (8 MPA.S)3YWG8XYT8HIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CETYL DIMETHICONE 25U4AS1BW4ZBIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
OATMEAL8PI54V663YIACT
CAPRYLYL GLYCOL00YIU5438UIACT
GLYCERYL DIBEHENATER8WTH25YS2IACT
SODIUM CHLORIDE451W47IQ8XIACT
CHLORPHENESINI670DAL4SZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
FEVERFEWZ64FK7P217IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
OCTYLDODECYL CITRATE CROSSPOLYMERX323T6QO4MIACT
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMERAE7QA6TW0QIACT
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
Aveeno Baby continuous protection sensitive skin Sunscreen Broad Spectrum SPF50ZINC OXIDEKenvue Brands LLCbbd6710f-a665-437e-b86b-437f732984d12025-03-04WarningsExact identifier
ndc (package): 69968-0304-1
ndc (package): 69968-0304-7
ndc (package): 69968-0304-6
ndc (package): 69968-0304-3
ndc (product): 69968-0304
ndc11 (package): 69968030401
ndc11 (package): 69968030407
ndc11 (package): 69968030406
ndc11 (package): 69968030403
spl id: 2f7f8556-263b-e99c-e063-6394a90af8ca
spl set id: bbd6710f-a665-437e-b86b-437f732984d1

Reported adverse events (FAERS/openFDA)#

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