FDA.reportPublic FDA data

Aveeno Baby Daily Care Set

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:34:29

Label at a glance#

ProductAveeno Baby Daily Care Set
Active ingredientDIMETHICONE
Label structure11 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped or cracked skin

Dosage and administration

Apply as needed.

Storage and handling

Remove quality seal. Do not use if quality seal is broken. Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1.2%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent and temporarily protects chafed, chapped or cracked skin

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • Symptoms last more than 7 days or clear up and occur again within a few days

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

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 as needed.

Other information

STORAGE AND HANDLING SECTION

  • Remove quality seal. Do not use if quality seal is broken.
  • Store at room temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Distearyldimonium Chloride, Petrolatum, Isopropyl Palmitate, Cetyl Alcohol, Avena Sativa (Oat) Kernel Flour, Benzyl Alcohol, Sodium Chloride, Allantoin

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

PRINCIPAL DISPLAY PANEL - Kit Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno
Baby ®

daily care set

trusted daily nourishment
for baby's skin

Cleanse Gently
12 FL. OZ. (354 mL)

Soothe and Moisturize
12 FL. OZ. (354 mL)

PRINCIPAL DISPLAY PANEL - Kit Container
PRINCIPAL DISPLAY PANEL - Kit Container

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876980dimethicone 1.2 % Topical LotionPSN7
876980dimethicone 12 MG/ML Topical LotionSCD7
876980dimethicone 1.2 % Topical LotionSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69968-0592-12024-01-30C16284748780-11030e365-6579-111a-e063-dadaa90a10e262025bfa-245e-4369-9949-d31ea455ad31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0441-2Aveeno Baby Daily Care Set354 mL in 1 BOTTLE, PUMPLOTION354 mL12 mg in 1mL7
69968-0592-1Aveeno Baby Daily Care Set1 in 1 CONTAINERKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0441AVEENO BABY DAILY CARE SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]7Current NDC, Legacy NDC20241107_62025bfa-245e-4369-9949-d31ea455ad31.zip
69968-0592AVEENO BABY DAILY CARE SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]7Current NDC, Legacy NDC, 2 package rows20241107_62025bfa-245e-4369-9949-d31ea455ad31.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
69968-059269968-0592-1
69968-044169968-0441-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
OATMEAL8PI54V663YIACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM CHLORIDE451W47IQ8XIACT
ALLANTOIN344S277G0ZIACT
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
SODIUM LAUROAMPHOACETATESLK428451LINGR
GLYCERINPDC6A3C0OXINGR
COCO GLUCOSIDEICS790225BINGR
SODIUM CHLORIDE451W47IQ8XINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
SODIUM BENZOATEOJ245FE5EUINGR
GLYCERYL OLEATE4PC054V79PINGR
SODIUM HYDROXIDE55X04QC32IINGR
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AINGR
BUTYLENE GLYCOL3XUS85K0RAINGR
OATZ6J799EAJKINGR

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Baby Daily Care SetDIMETHICONEKenvue Brands LLC62025bfa-245e-4369-9949-d31ea455ad312024-11-05WarningsExact identifier
ndc (package): 69968-0592-1
ndc (package): 69968-0441-2
ndc (product): 69968-0592
ndc11 (package): 69968044102
ndc11 (package): 69968059201
spl id: 21a6ab83-7d2c-be7e-e063-6394a90ac060
spl set id: 62025bfa-245e-4369-9949-d31ea455ad31
Aveeno Baby Daily Care SetDIMETHICONEKenvue Brands LLC3d3da49e-dba6-4c6b-9278-5c8692e29f142024-11-05WarningsExact identifier
ndc (package): 69968-0441-2
ndc11 (package): 69968044102
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLCb34c8e71-7fad-484c-b387-3c424f50b7432024-09-19WarningsExact identifier
ndc (package): 69968-0441-2
ndc (product): 69968-0441
ndc11 (package): 69968044102

Reported adverse events (FAERS/openFDA)#

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