FDA.reportPublic FDA data

ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT

Manufacturer
REVLON | BEAUTYGE S.L.
Effective date
2025-08-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:09:11

Label at a glance#

ProductEA EIGHT HOUR SKIN PROTECTANT
Active ingredientPETROLATUM
Label structure11 sections

Indications and uses

Treats symptoms of: ■ chapping ■ peeling or flaking due to minor burns ■ sunburn ■ windburn ■ scrapes ■ abrasions ■ cracked lips

Dosage and administration

■ Apply liberally as often as necessary

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 56.8%................... Skin Protectant

OTHER INGREDIENTS

INACTIVE INGREDIENT SECTION

LANOLIN, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINERALE, CAPRYLYL GLYCOL, GLYCINE SOJA (SOYBEAN) OIL, PARFUM/FRAGRANCE, RICINUS COMMUNIS (CASTOR) SEED OIL, SALICYLIC ACID, TOCOPHEROL, ZEA MAYS (CORN) OIL, BHT, CITRAL, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492).

USES

INSTRUCTIONS FOR USE SECTION

Treats symptoms of:
■ chapping

■ peeling or flaking due to minor burns

■ sunburn
■ windburn

■ scrapes

■ abrasions
■ cracked lips

WARNINGS

SAFE HANDLING WARNING 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

DIRECTIONS

OTC - WHEN USING SECTION

■ Apply liberally as often as necessary

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally as often as necessary

WARNINGS SECTION

  • For external use only

INDICATIONS & USAGE SECTION

Uses

Treats symptoms of:

  • chapping
  • peeling or flaking due to minor burns
  • suncrun
  • windburn
  • scrapes
  • abrasions
  • cracked lips

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

NA

OTC - PURPOSE SECTION

Skin Protectant

CARTON ART

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 HR SKIN PROTECT8 HR SKIN PROTECT

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10967-672-172025-08-01C16284748780-1d6a99b39-663b-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT
10967-672-172023-07-28C16284748780-1d6a99b39-663b-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT
10967-672-172022-02-09C16284748780-1d6a99b39-663b-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT
10967-672-172022-01-28C16284748780-1d6a99b39-663b-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-672-17EA EIGHT HOUR SKIN PROTECTANT50 g in 1 TUBEEMULSION503

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-67210967-672-17

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
LANOLIN7EV65EAW6HIACT
MINERAL OILT5L8T28FGPIACT
SOYBEAN OIL241ATL177AIACT
PETROLATUM4T6H12BN9UACTIB
FERRIC OXIDE RED1K09F3G675IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
GERANIOLL837108USYIACT
CORN OIL8470G57WFMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CASTOR OILD5340Y2I9GIACT
CITRALT7EU0O9VPPIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SALICYLIC ACIDO414PZ4LPZIACT
TOCOPHEROLR0ZB2556P8IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT

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
EA EIGHT HOUR SKIN PROTECTANTPETROLATUMREVLONb590991c-8ec8-67c2-e053-2a95a90a3acf2025-08-01WarningsExact identifier
ndc (package): 10967-672-17
ndc (product): 10967-672
ndc11 (package): 10967067217
spl id: 3b516086-ba84-c160-e063-6294a90a78af
spl set id: b590991c-8ec8-67c2-e053-2a95a90a3acf

Reported adverse events (FAERS/openFDA)#

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