FDA.reportPublic FDA data

Aveeno Baby ® Soothing Relief Moisturizing Cream

Manufacturer
Johnson & Johnson Consumer Inc.
Effective date
2019-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:50:57

Label at a glance#

ProductAveeno Baby Soothing Relief Moisturizing
Active ingredientDimethicone
Label structure11 sections

Indications and uses

Helps prevent and temporarily protects chafed, chapped or cracked skin

Dosage and administration

Twist off cap, remove quality seal. Apply liberally or as needed. Do not use if quality seal is broken

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

  • Twist off cap, remove quality seal. Apply liberally or as needed. Do not use if quality seal is broken

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

Questions?

OTC - QUESTIONS SECTION

Call toll-free 866-4AVEENO or 215-273-8755 (collect).www.aveeno.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 226 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aveeno
Baby®

PEDIATRICIAN
Aveeno®
RECOMMENDED®

FRAGRANCE-FREE.PARABEN-FREE
PHTHALATE-FREE

Soothing Relief
Moisturizing Cream

Dimethicone Skin Protectant
Natural Triple Oat Complex

Clinically Shown to
Soothe & Relieve Dry Sensitive Skin

Moisturizes for 24 Hours

NET WT. 8 OZ. (226 g)

Principal Display Panel - 226 g Tube Label
Principal Display Panel - 226 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
69968-019869968-0198-8, 69968-0198-5

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
Dimethicone92RU3N3Y1OACTIB
Water059QF0KO0RIACT
GlycerinPDC6A3C0OXIACT
Distearyldimonium ChlorideOM9573ZX3XIACT
Petrolatum4T6H12BN9UIACT
Isopropyl Palmitate8CRQ2TH63MIACT
Cetyl Alcohol936JST6JCNIACT
Oatmeal8PI54V663YIACT
OatZ6J799EAJKIACT
Oat Kernel Oil3UVP41R77RIACT
Shea ButterK49155WL9YIACT
Steareth-20L0Q8IK9E08IACT
Sodium Chloride451W47IQ8XIACT
Benzyl AlcoholLKG8494WBHIACT

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
cb8fe0fa-79b3-7cac-e053-2a95a90a79edc2a7d5bb-a904-4cde-990d-b096574f6afc2021-09-09WarningsExact identifier
spl set id: c2a7d5bb-a904-4cde-990d-b096574f6afc

Reported adverse events (FAERS/openFDA)#

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