FDA.reportPublic FDA data

ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER

Manufacturer
REVLON
Effective date
2024-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:10

Label at a glance#

ProductEIGHT HOUR NIGHT
Active ingredientDIMETHICONE
Label structure9 sections

Indications and uses

Uses - Treats symptoms of chapped or cracked skin. - Helps prevent and protect from drying effects of wind and cold weather. Directions - Apply liberally as often as necessary

Dosage and administration

Uses - Treats symptoms of chapped or cracked skin. - Helps prevent and protect from drying effects of wind and cold weather. Directions - Apply liberally as often as necessary

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose
Dimethicone 2.0%...................................... Skin Protectant

Inactive Ingredients

INACTIVE INGREDIENT SECTION

PETROLATUM, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, LANOLIN, ISONONYL ISONONANOATE, HYDROGENATED POLYISOBUTENE, ISOPROPYL MYRISTATE, ISOPROPYL PALMITATE, BUTYROSPERMUM PARKII (SHEA) BUTTER, POLYBUTENE, TRIISOSTEARIN, OLEYL ERUCATE, POLYPROPYLENE, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, SYNTHETIC WAX, CYCLOPENTASILOXANE, RICINUS COMMUNIS (CASTOR) SEED OIL, GLYCERYL BEHENATE/EICOSADIOATE, HYDROGENATED LECITHIN, DIMETHICONOL, GLYCERYL CITRATE/LACTATE/LINOLEATE/OLEATE, PARFUM/FRAGRANCE, SALICYLIC ACID, TOCOPHEROL, TOCOPHERYL ACETATE, VEGETABLE OIL/OLUS/HUILE VEGETALE, ALPHA-ISOMETHYL IONONE, BENZYL SALICYLATE, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, YELLOW 6 LAKE (CI 15985).

Uses and Directions

INSTRUCTIONS FOR USE SECTION

Uses
- Treats symptoms of chapped or cracked skin.
- Helps prevent and protect from drying effects of wind and cold weather.

Directions

- Apply liberally as often as necessary

Warnings

WARNINGS SECTION

Warnings
For external use only
When using this product
- Avoid contact with eyes

- Do not apply over puncture wounds, infections or lacerations

Stop using and ask a doctor if
- Symptoms persist more than 7 days

DOSAGE & ADMINISTRATION SECTION

As Needed

INDICATIONS & USAGE SECTION

  • Treats symptoms of chapped or cracked skin
  • Helps prevent and protect from drying effects of wind and cold weather

OTC - PURPOSE SECTION

Skin Protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

carton art

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

eight hr nighteight hr night

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
10967-675-162022-02-09C16284748780-1d6a99b39-64e5-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER
10967-675-162022-01-28C16284748780-1d6a99b39-64e5-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT NIGHTTIME MIRACLE MOISTURIZER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-675-16EIGHT HOUR NIGHT45 g in 1 JAREMULSION453

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-675EIGHT HOUR NIGHT (DIMETHICONE) EMULSION [REVLON]3Current NDC, Legacy NDC, 1 package rows20240113_b3b277f9-565a-636c-e053-2995a90a94d2.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-67510967-675-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
SALICYLIC ACIDO414PZ4LPZIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
GLYCERYL BEHENATE/EICOSADIOATE73CJJ317SRIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
CYCLOMETHICONE 50THT5PCI0RIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
HYDROGENATED POLYBUTENE (1300 MW)7D1YQ9Y5EZIACT
SHEA BUTTERK49155WL9YIACT
OLEYL ERUCATE753W099NQ6IACT
PETROLATUM4T6H12BN9UIACT
MINERAL OILT5L8T28FGPIACT
TOCOPHEROLR0ZB2556P8IACT
CORN OIL8470G57WFMIACT
ISOMETHYL-.ALPHA.-IONONE9XP4LC555BIACT
DIMETHICONE92RU3N3Y1OACTIB
MICROCRYSTALLINE WAXXOF597Q3KYIACT
LANOLIN7EV65EAW6HIACT
DIMETHICONOL (100000 CST)OSA9UP217SIACT
GERANIOLL837108USYIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
POLYPROPYLENE (30000 MW)T71QXI2O62IACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT

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
EIGHT HOUR NIGHTDIMETHICONEREVLONb3b277f9-565a-636c-e053-2995a90a94d22024-01-12WarningsExact identifier
ndc (package): 10967-675-16
ndc (product): 10967-675
ndc11 (package): 10967067516
spl id: 0ec6d442-3cb3-709b-e063-6394a90a795d
spl set id: b3b277f9-565a-636c-e053-2995a90a94d2

Reported adverse events (FAERS/openFDA)#

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