FDA.reportPublic FDA data

Aveeno Baby Calming Comfort Bath Plus Set

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:34:54

Label at a glance#

ProductAveeno Baby Calming Comfort Bath Plus Set
Active ingredientDIMETHICONE
Label structure11 sections

Indications and uses

Temporarily protects and helps relieve chafed, chapped, or cracked skin Helps prevent and protect from the drying effects of wind and cold weather.

Dosage and administration

Apply as needed.

Storage and handling

To open, twist off cap and remove quality seal. Do not use if 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

  • Temporarily protects and helps relieve chafed, chapped, or cracked skin
  • Helps prevent and protect from the drying effects of wind and cold weather.

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 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, Fragrance, Sodium Chloride

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 Packet

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno ®
baby
calming comfort ®
bath + lotion set

18 FL OZ (532 mL)

NET WT. 8 OZ (227 g)

PRINCIPAL DISPLAY PANEL - Kit Packet
PRINCIPAL DISPLAY PANEL - Kit Packet

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
876980dimethicone 1.2 % Topical LotionPSN6
876980dimethicone 12 MG/ML Topical LotionSCD6
876980dimethicone 1.2 % Topical LotionSY6

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69968-0631-92024-01-30C16284748780-11030e365-559d-111a-e063-dadaa90a10e2Aveeno ® baby calming comfort ® bath plus lotion set Aveeno baby calming comfort ® lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0631-9Aveeno Baby Calming Comfort Bath Plus Set1 in 1 PACKETKIT16
69968-0656-8Aveeno Baby Calming Comfort Bath Plus Set227 g in 1 TUBELOTION227 g12 mg in 1g6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0631AVEENO BABY CALMING COMFORT BATH PLUS SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]6Current NDC, Legacy NDC, 2 package rows20241108_2c44fbc7-588f-41e2-953c-eebf24eecbf9.zip
69968-0656AVEENO BABY CALMING COMFORT BATH PLUS SET (DIMETHICONE) KIT [KENVUE BRANDS LLC]6Current NDC, Legacy NDC20241108_2c44fbc7-588f-41e2-953c-eebf24eecbf9.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-063169968-0631-9
69968-065669968-0656-8

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
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM CHLORIDE451W47IQ8XIACT
DIMETHICONE92RU3N3Y1OACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
OATMEAL8PI54V663YIACT
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
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YINGR
SODIUM HYDROXIDE55X04QC32IINGR
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aveeno Baby Calming Comfort Bath Plus SetDIMETHICONEKenvue Brands LLC2c44fbc7-588f-41e2-953c-eebf24eecbf92024-11-06WarningsExact identifier
ndc (package): 69968-0631-9
ndc (package): 69968-0656-8
ndc (product): 69968-0631
ndc11 (package): 69968065608
ndc11 (package): 69968063109
spl id: 21eb65dd-5180-a1df-e063-6294a90ae27f
spl set id: 2c44fbc7-588f-41e2-953c-eebf24eecbf9
Aveeno Baby Calming ComfortDIMETHICONEKenvue Brands LLC029fbae2-06ad-4fe9-b542-834686c5cb972024-11-05WarningsExact identifier
ndc (package): 69968-0656-8
ndc (product): 69968-0656
ndc11 (package): 69968065608

Reported adverse events (FAERS/openFDA)#

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