FDA.reportPublic FDA data

ELIZABETH ARDEN EIGHT HOUR CREAM LIP PROTECTANT STICK SUNSCREEN SPF 15- CLEAR

Manufacturer
REVLON CONSUMER PRODUCTS CORP | REVLON, INC
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:50:18

Label at a glance#

ProductELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR
Active ingredientPETROLATUM, OCTINOXATE, OXYBENZONE, AVOBENZONE
Label structure12 sections

Indications and uses

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

Dosage and administration

Directions Apply liberally as often as necessary For Sunscreen Use: Apply liberally 15 minutes before sun exposure reapply: atleast every 2 hours children under 6 months: Ask a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT PURPOSE

PETROLATUM 31.0% SKIN PROTECTANT

AVOBENZONE 2.0% SUNSCREEN

OCTINOXATE 7.5% SUNSCREEN

OXYBENZONE 3.0% SUNSCREEN

USES

INSTRUCTIONS FOR USE SECTION

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

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

  • For external use only
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs or if condition lasts more than 7 days.
  • Keep out of reach of children.If product is swallowed get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

Directions

  • Apply liberally as often as necessary

For Sunscreen Use:

  • Apply liberally 15 minutes before sun exposure
  • reapply:
  • atleast every 2 hours
  • children under 6 months: Ask a doctor.

Other Information

OTHER SAFETY INFORMATION

Other information

  • Protect this product from excessive heat and direct sun

Inactive ingedients

INACTIVE INGREDIENT SECTION

Polybutene, Bis-Diglyceryl Polyacyladipate-2, Polyethylene, Diisostearyl Malate, Ozokerite, Lanolin, Octyldodecyl Neopentanoate, Synthetic Fluorphlogopite, Hydrogenated Polyisobutene, Cetyl PEG/PPG-10/1 Dimethicone, Mica, Polyglyceryl-4 Isostearate, Hexyl Laurate, Synthetic Wax, BHT, Butyrospermum Parkii (Shea) Butter, Cera Alba/Beeswax/Cire D’abeille, Cocos Nucifera (Coconut) Oil, Tocopheryl Acetate, Parfum (Fragrance), Citral, Citronellol, Geraniol, Limonene, Linalool, Benzoic Acid. MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-): [Iron Oxides (CI 77491), Iron Oxides (CI 77499), Red 33 Lake (CI 17200), Red 6 Lake (CI 15850), Red 7 Lake (CI 15850), Titanium Dioxide (CI 77891), Yellow 5 Lake (CI 19140).]

Questions or Comments?

OTC - QUESTIONS SECTION

  • Call toll free 1-800-326-7337
  • Monday to Friday, 10:00AM to 7:00PM EST

Skin protectant Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally as often as necessary

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If product is swallowed, get medical help or contact poison control center right away.

Uses

OTC - PURPOSE SECTION

  • Helps prevent sunburn
  • Temporarily protects and helps relieve
  • Chapping
  • Peeling or flaking due to minor sunburn
  • Windburn
  • Cracked lips

Directions and Usage

INDICATIONS & USAGE SECTION

  • Apply liberally as often as necessary
  • For sunscreen use: apply liberally 15 minutes before sun exposure
  • Reapply: atleast every 2 hours
  • Children under 6 months: ask a doctor

Packaging Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton PackagingCarton PackagingOnsertOnsert

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-676-64ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR3.7 g in 1 TUBELIPSTICK3.72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-676ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR (LIP PROTECTANT) LIPSTICK [REVLON CONSUMER PRODUCTS CORP]2Current NDC, 1 package rows20250101_f3a6fe29-7af7-bfb1-e053-2a95a90a0101.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
10967-67610967-676-64

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICAV8A1AW0880IACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
CERESINQ1LS2UJO3AIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
PETROLATUM4T6H12BN9UACTIB
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
COCONUT OILQ9L0O73W7LIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
FRAGRANCE 135765EM498GW35IACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
LANOLIN7EV65EAW6HIACT
AVOBENZONEG63QQF2NOXACTIB
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
BENZOIC ACID8SKN0B0MIMIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
HEXYL LAURATE4CG9F9W01QIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
POLYISOBUTYLENE (1000 MW)5XB3A63Y52IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
ELIZABETH ARDEN EIGHT HR PROTECTANT CLEARLIP PROTECTANTREVLON CONSUMER PRODUCTS CORPf3a6fe29-7af7-bfb1-e053-2a95a90a01012024-12-30WarningsExact identifier
ndc (package): 10967-676-64
ndc (product): 10967-676
ndc11 (package): 10967067664
spl id: 2a85bd43-4196-6ed7-e063-6294a90a84d4
spl set id: f3a6fe29-7af7-bfb1-e053-2a95a90a0101

Reported adverse events (FAERS/openFDA)#

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