FDA.reportPublic FDA data

Aveeno Baby Welcome Little One Gift Basket

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:35:08

Label at a glance#

ProductAveeno Baby Welcome Little One Gift Basket
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

To open, twist off cap and remove quality seal. Do not use if quality seal is broken. Store at room temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Aveeno ® baby daily moisture lotion

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

  • To open, twist off cap and 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 Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RECOMMENDED BY

PEDIATRICIANS

& DERMATOLOGISTS

Aveeno®

baby

NEW

Includes

1oz travel size

welcome little one

gift basket

Everyday gentle essentials to calm, cleanse, and moisturize baby

Aveeno®

baby

Gift basket

Includes :

Daily Moisture Wash &

Shampoo (8 fl oz & 1 fl oz)

Gently cleanses and

nourishes baby’s hair

and sensitive skin

CALMING COMFORT® Bath

(8 fl oz)

Gently cleanses baby’s

delicate skin and helps

calm baby before bedtime

Daily Moisture Lotion

(8 fl oz)

Protects and moisturizes

baby’s sensitive skin for

24hrs

Sensitive All Over Wipes

(64 ct)

Wipes away dirt and germs

and contains oat extract and

aloe

Aveeno_001Aveeno_001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876980dimethicone 1.2 % Topical LotionPSN4
876980dimethicone 12 MG/ML Topical LotionSCD4
876980dimethicone 1.2 % Topical LotionSY4

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
69968-0766-92024-01-30C16284748780-11030e365-2497-111a-e063-dadaa90a10e2Aveeno ® Baby Welcome Little One Gift Basket

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0679-8Aveeno Baby Welcome Little One Gift Basket227 g in 1 TUBELOTION227 g12 mg in 1g4
69968-0766-9Aveeno Baby Welcome Little One Gift Basket1 in 1 PACKAGEKIT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0679AVEENO BABY WELCOME LITTLE ONE GIFT BASKET (DIMETHICONE) KIT [KENVUE BRANDS LLC]4Current NDC, Legacy NDC20241108_e05e3c63-1691-7a86-e053-2a95a90a6bcb.zip
69968-0766AVEENO BABY WELCOME LITTLE ONE GIFT BASKET (DIMETHICONE) KIT [KENVUE BRANDS LLC]4Current NDC, Legacy NDC, 2 package rows20241108_e05e3c63-1691-7a86-e053-2a95a90a6bcb.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-076669968-0766-9
69968-067969968-0679-8

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 63 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UIACT
OATZ6J799EAJKIACT
BENZYL ALCOHOLLKG8494WBHIACT
ALLANTOIN344S277G0ZIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
CETYL ALCOHOL936JST6JCNIACT
SODIUM CHLORIDE451W47IQ8XIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
SODIUM LAUROAMPHOACETATESLK428451LINGR
GLYCERINPDC6A3C0OXINGR
COCO GLUCOSIDEICS790225BINGR
SODIUM CHLORIDE451W47IQ8XINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
SODIUM BENZOATEOJ245FE5EUINGR
GLYCERYL MONOOLEATEC4YAD5F5G6INGR
SODIUM HYDROXIDE55X04QC32IINGR
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AINGR
OATZ6J799EAJKINGR
WATER059QF0KO0RINGR
COCAMIDOPROPYL BETAINE5OCF3O11KXINGR
SODIUM LAUROAMPHOACETATESLK428451LINGR
GLYCERINPDC6A3C0OXINGR
COCO GLUCOSIDEICS790225BINGR
SODIUM CHLORIDE451W47IQ8XINGR
CITRIC ACID MONOHYDRATE2968PHW8QPINGR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COINGR
SODIUM BENZOATEOJ245FE5EUINGR
GLYCERYL MONOOLEATEC4YAD5F5G6INGR
SODIUM HYDROXIDE55X04QC32IINGR
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AINGR
OATZ6J799EAJKINGR
SODIUM LAUROAMPHOACETATESLK428451LINGR
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YINGR
WATER059QF0KO0RINGR

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Baby Welcome Little One Gift BasketDIMETHICONEKenvue Brands LLCe05e3c63-1691-7a86-e053-2a95a90a6bcb2024-11-06WarningsExact identifier
ndc (package): 69968-0679-8
ndc (package): 69968-0766-9
ndc (product): 69968-0766
ndc11 (package): 69968076609
ndc11 (package): 69968067908
spl id: 224bf403-f91f-a128-e063-6294a90a75fa
spl set id: e05e3c63-1691-7a86-e053-2a95a90a6bcb
Aveeno Baby Daily MoistureDIMETHICONEKenvue Brands LLC3879110f-ba83-446b-b580-f8eaa859789d2024-11-05WarningsExact identifier
ndc (package): 69968-0679-8
ndc (product): 69968-0679
ndc11 (package): 69968067908

Reported adverse events (FAERS/openFDA)#

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