FDA.reportPublic FDA data

Aveeno SKIN RELIEF OVERNIGHT cream

Manufacturer
Kenvue Brands LLC
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:34:35

Label at a glance#

ProductAveeno Skin Relief Overnight
Active ingredientDIMETHICONE
Label structure11 sections

Indications and uses

Helps prevent and temporarily protects 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

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
  • 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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Other information

STORAGE AND HANDLING SECTION

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, methylparaben, sodium chloride, butyrospermum parkii (shea) butter, propylene glycol, chamomilla recutita (matricaria) flower extract, avena sativa (oat) kernel extract

Questions?

OTC - QUESTIONS SECTION

Call toll-free 866-428-3366 or 215-273-8755 (collect) or visit www.aveeno.com

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 207 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW LOOK
SAME GREAT FORMULA
Aveeno ®
SKIN RELIEF
OVERNIGHT
cream
INTENSE MOISTURE
Dimethicone skin protectant
Soothes Itchy,
Very Dry Skin
Works throughout
the night
DERMATOLOGIST
THERAPEUTIC
RECOMMENDED BRAND

fragrance
free

with
TRIPLE OAT COMPLEX
& NATURAL SHEA BUTTER
net wt. 7.3 oz (207 g)

PRINCIPAL DISPLAY PANEL - 207 g Tube Label
PRINCIPAL DISPLAY PANEL - 207 g Tube Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1310125dimethicone 1.2 % Topical CreamPSN5
1310125dimethicone 12 MG/ML Topical CreamSCD5
1310125dimethicone 1.2 % Topical CreamSY5

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69968-0488-7Aveeno Skin Relief Overnight207 g in 1 TUBECREAM2075

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0488AVEENO SKIN RELIEF OVERNIGHT (DIMETHICONE) CREAM [KENVUE BRANDS LLC]5Current NDC, Legacy NDC, 1 package rows20241107_e7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69968-048869968-0488-7

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
PETROLATUM4T6H12BN9UIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CETYL ALCOHOL936JST6JCNIACT
OATMEAL8PI54V663YIACT
BENZYL ALCOHOLLKG8494WBHIACT
OAT KERNEL OIL3UVP41R77RIACT
STEARETH-20L0Q8IK9E08IACT
METHYLPARABENA2I8C7HI9TIACT
OATZ6J799EAJKIACT
SODIUM CHLORIDE451W47IQ8XIACT
SHEA BUTTERK49155WL9YIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
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
Aveeno Skin Relief OvernightDIMETHICONEKenvue Brands LLCe7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c2024-11-05WarningsExact identifier
ndc (package): 69968-0488-7
ndc (product): 69968-0488
ndc11 (package): 69968048807
spl id: 22782da1-8a43-5fb7-e063-6394a90a680b
spl set id: e7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c

Reported adverse events (FAERS/openFDA)#

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