FDA.reportPublic FDA data

Aveeno Baby Soothing Hydration Creamy Oil

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2023-03-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:35:22

Label at a glance#

ProductAveeno Baby Soothing Hydration Creamy Oil
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

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

OTC - WHEN USING SECTION

When using this product

  • Do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - DO NOT USE SECTION

Do not use on

  • 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, Avena Sativa (Oat) Kernel Oil, Steareth-20, Tocopheryl Acetate, Sodium Chloride, Butyrospermum Parkii (Shea) Butter, Avena Sativa (Oat) Kernel Extract

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 - 227 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RECOMMENDED BY
PEDIATRICIANS
& DERMATOLOGISTS
Aveeno ®
baby
soothing hydration
New Look
Now with
Vitamin E
creamy
oil
dimethicone skin protectant
with 100% pure oat oil
+ vitamin E
helps heal dry skin
restores essential
moisture to baby's
sensitive skin
fragrance-free
hypoallergenic
NET WT. 8 OZ (227 g)

Principal Display Panel - 227 g Tube Label
Principal Display Panel - 227 g Tube Label

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-063069968-0630-5, 69968-0630-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
OATZ6J799EAJKIACT
BENZYL ALCOHOLLKG8494WBHIACT
OAT KERNEL OIL3UVP41R77RIACT
STEARETH-20L0Q8IK9E08IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM CHLORIDE451W47IQ8XIACT
SHEA BUTTERK49155WL9YIACT
DIMETHICONE92RU3N3Y1OACTIB

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
f5d0c5bf-f214-7932-e053-2995a90a02c6003fb7de-3c39-4840-ad3c-b2e83e1e22782023-03-01WarningsExact identifier
spl id: f5d0c5bf-f214-7932-e053-2995a90a02c6
spl set id: 003fb7de-3c39-4840-ad3c-b2e83e1e2278

Reported adverse events (FAERS/openFDA)#

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