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EIGHT HOUR SKIN FRAGRANCE FREE

ELIZABETH ARDEN EIGHT HOUR CREAM SKIN PROTECTANT FRAGRANCE FREE

Approved
Approval ID

b61d6e2e-18dd-37d2-e053-2a95a90af57b

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 Code10967-673
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 (15)

ACACIA DECURRENS WHOLEInactive
Code: 8KZ75S2VSK
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
SALICYLIC ACIDInactive
Code: O414PZ4LPZ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
PETROLATUMActive
Quantity: 56.8 mg in 1 g
Code: 4T6H12BN9U
Classification: ACTIB
CORN OILInactive
Code: 8470G57WFM
Classification: IACT
DIPTERYX ODORATA SEEDInactive
Code: D43A5L1U6L
Classification: IACT
VANILLINInactive
Code: CHI530446X
Classification: IACT
CASTOR OILInactive
Code: D5340Y2I9G
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
LANOLINInactive
Code: 7EV65EAW6H
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 4/15/2013

CARTON ART

8HR FF

INDICATIONS & USAGE SECTION

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

USES

Treats symptoms of:

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 4/15/2013

ACTIVE INGREDIENT

PETROLATUM 56.8%

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 4/15/2013

INACTIVE INGREDIENTS

LANOLIN, MINERAL OIL/PARAFFINUM LIQUIDUM/HUILE MINÉRALE, ACACIA DECURRENS EXTRACT, DIPTERYX ODORATA BEAN EXTRACT, VANILLIN, TOCOPHEROL, TOCOPHERYL ACETATE, BHT, SALICYLIC ACID, RICINUS COMMUNIS (CASTOR) SEED OIL, VEGETABLE OIL/OLUS/HUILE VÉGÉTALE, ZEA MAYS (CORN) OIL, BENZYL ALCOHOL, IRON OXIDES

INSTRUCTIONS FOR USE SECTION

LOINC: 59845-8Updated: 4/15/2013

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: 4/15/2013

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: 4/15/2013

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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EIGHT HOUR SKIN FRAGRANCE FREE - FDA Drug Approval Details