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EA EIGHT HOUR SKIN PROTECTANT

ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT

Approved
Approval ID

b590991c-8ec8-67c2-e053-2a95a90a3acf

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 1, 2025

Manufacturers
FDA

REVLON

DUNS: 788820165

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

PETROLATUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code10967-672
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
PETROLATUM
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 1, 2025
FDA Product Classification

INGREDIENTS (18)

LIMONENE, (+)-Inactive
Code: GFD7C86Q1W
Classification: IACT
LINALOOL, (+/-)-Inactive
Code: D81QY6I88E
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
PETROLATUMActive
Quantity: 56.8 mg in 1 g
Code: 4T6H12BN9U
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
GERANIOLInactive
Code: L837108USY
Classification: IACT
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
CITRALInactive
Code: T7EU0O9VPP
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
SALICYLIC ACIDInactive
Code: O414PZ4LPZ
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
.BETA.-CITRONELLOL, (R)-Inactive
Code: P01OUT964K
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/16/2016

CARTON ART

8 HR SKIN PROTECT

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/1/2025

Uses

Treats symptoms of:

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/16/2016

ACTIVE INGREDIENTS

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/16/2020

OTHER INGREDIENTS

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).

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 2/16/2016

USES

Treats symptoms of:
■ chapping

■ peeling or flaking due to minor burns

■ sunburn
■ windburn

■ scrapes

■ abrasions
■ cracked lips

SAFE HANDLING WARNING SECTION

LOINC: 50741-8Updated: 2/16/2016

WARNINGS

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

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 2/16/2016

DIRECTIONS

■ Apply liberally as often as necessary

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/1/2025
  • Apply liberally as often as necessary

WARNINGS SECTION

LOINC: 34071-1Updated: 1/1/2025
  • For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/1/2025

NA

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/1/2025

Skin Protectant

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EA EIGHT HOUR SKIN PROTECTANT - FDA Drug Approval Details