FDA.reportPublic FDA data

ELIZABETH ARDEN EIGHT HOUR LIP PROTECTANT

Manufacturer
ELIZABETH ARDEN, INC
Effective date
2017-08-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:52:22

Label at a glance#

ProductELIZABETH ARDEN EIGHT HOUR LIP PROTECTANT
Active ingredientPETROLATUM
Label structure7 sections

Indications and uses

Temporarily protects and helps relieve chapping peeling or flaking due to minor sunburn windburn cracked lips

Dosage and administration

Apply liberally as often as necessary

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 85%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps relieve
  • chapping
  • peeling or flaking due to minor sunburn
  • windburn
  • cracked lips

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally as often as necessary

Inactive Ingredients

INACTIVE INGREDIENT SECTION

LANOLIN, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, BIS-DIGLYCERYL POLYACYLADIPATE-2, LANOLIN OIL, PARFUM/FRAGRANCE, CITRAL, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, IRON OXIDES (CI 77499), TITANIUM DIOXIDE (CI 77891), YELLOW 5 LAKE (CI 19140), YELLOW 6 LAKE (CI 15985).

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800 326-7337

Principal Display Panel - Eight Hour Lip Protectant Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ElizabethArden

NEW YORK

AROUND
WITH 8 HOUR
THE WORLD

Take Off
and Touch Down

Lip Duo

Lip Scrub

Lip Protectant

NET WT. .45 OZ. 13g EACH

Principal Display Panel - Eight Hour Lip Protectant Carton Label
Principal Display Panel - Eight Hour Lip Protectant Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67938-3052-12021-01-29C16284748780-1ba0f9c33-4101-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67938-3052-1ELIZABETH ARDEN EIGHT HOUR LIP PROTECTANT1 in 1 CARTONGEL11
67938-3052-1ELIZABETH ARDEN EIGHT HOUR LIP PROTECTANT13 g in 1 CANISTERGEL131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67938-3052ELIZABETH ARDEN EIGHT HOUR LIP PROTECTANT (PETROLATUM) GEL [ELIZABETH ARDEN, INC]1Legacy NDC, 2 package rows20170830_9565632a-32a4-45be-beb8-27957e9a4c00.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67938-305267938-3052-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
LANOLIN7EV65EAW6HIACT
CARNAUBA WAXR12CBM0EIZIACT
LANOLIN OILOVV5IIJ58FIACT
CITRALT7EU0O9VPPIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
GERANIOLL837108USYIACT
LINALOOL, (+/-)-D81QY6I88EIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C YELLOW NO. 6H77VEI93A8IACT

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
f2becf1b-e62b-4825-918d-b0719a16f6f09565632a-32a4-45be-beb8-27957e9a4c002017-08-01Exact identifier
spl id: f2becf1b-e62b-4825-918d-b0719a16f6f0
spl set id: 9565632a-32a4-45be-beb8-27957e9a4c00

Reported adverse events (FAERS/openFDA)#

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