FDA.reportPublic FDA data

ELIZABETH ARDEN EIGHT HOUR CREAM LIP PROTECTANT STICK SPF 15

Manufacturer
REVLON
Effective date
2024-12-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:48:37

Label at a glance#

ProductEIGHT HOUR LIP PROTECTANT SPF 15
Active ingredientAVOBENZONE, OCTINOXATE, OXYBENZONE, PETROLATUM
Label structure10 sections

Indications and uses

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: - at least every 2 hours children under 6 months: Ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose
PETROLATUM 30.2% ............. Skin Protectant
PADIMATE O 8.0%....................Sunscreen
OXYBENZONE 3.0%.................Sunscreen

Inactive Ingredients

INACTIVE INGREDIENT SECTION

RICINUS COMMUNIS (CASTOR) SEED OIL, OZOKERITE, GLYCERYL ROSINATE, CETYL LACTATE, LANOLIN OIL, MYRISTYL LACTATE, CETYL ACETATE, EUPHORBIA CERIFERA (CANDELILLA) WAX/CANDELILLA CERA/CIRE DE CANDELILLA, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, MYRISTYL ALCOHOL, ACETYLATED LANOLIN ALCOHOL, BEESWAX/CERA ALBA/CIRE D'ABEILLE, CAPRYLYL GLYCOL, GLYCINE SOJA (SOYBEAN) OIL, METHYLSTYRENE/VINYLTOLUENE COPOLYMER, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PARFUM/FRAGRANCE, TOCOPHEROL, ZEA MAYS (CORN) OIL, BHT, CITRAL, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, PHENOXYETHANOL, IRON OXIDES (CI 77491, CI 77492, CI 77499), TITANIUM DIOXIDE (CI 77891).

Uses

INSTRUCTIONS FOR USE SECTION

Uses

  • helps prevent sunburn
  • Temporarily protects and helps relieve

- chapping

- peeling or flaking due to minor sunburn

- windburn

- cracked lips

Warnings

WARNINGS SECTION

Warnings
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 for Use

OTC - WHEN USING SECTION

Directions

  • Apply liberally as often as necessary

For Sunscreen Use:

  • Apply liberally 15 minutes before sun exposure
  • reapply:

- at least every 2 hours

  • children under 6 months: Ask a doctor.

DOSAGE & ADMINISTRATION SECTION

As needed

INDICATIONS & USAGE SECTION

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

OTC - PURPOSE SECTION

Sunscreen

Skin Protectant

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

carton art

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8hr lip plain8hr lip plain

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
10967-692-61EIGHT HOUR LIP PROTECTANT SPF 153.7 g in 1 CARTRIDGELIPSTICK3.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-692EIGHT HOUR LIP PROTECTANT SPF 15 (PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE) LIPSTICK [REVLON]1Current NDC, 1 package rows20241226_2a0ac6aa-0315-d79e-e063-6294a90a9c53.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
10967-69210967-692-61

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
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TIACT
HYDROGENATED POLYISOBUTENE (1300 MW)7D1YQ9Y5EZIACT
BEESWAX2ZA36H0S2VIACT
CERESINQ1LS2UJO3AIACT
BHT1P9D0Z171KIACT
ACID YELLOW 23 ALUMINUM LAKEJQ6BLH9FR7IACT
LANOLIN7EV65EAW6HIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
IRON OXIDES1K09F3G675IACT
BENZOIC ACID8SKN0B0MIMIACT
SHEA BUTTERK49155WL9YIACT
COCONUT OILQ9L0O73W7LIACT
AVOBENZONEG63QQF2NOXACTIB
POLYETHYLENEUG00KM4WR7IACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
MICAV8A1AW0880IACT
HEXYL LAURATE4CG9F9W01QIACT
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
DIISOSTEARYL MALATEQBS8A3XZGQIACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
OCTINOXATE4Y5P7MUD51ACTIB
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
OXYBENZONE95OOS7VE0YACTIB
PETROLATUM4T6H12BN9UACTIB

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
EIGHT HOUR LIP PROTECTANT SPF 15PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONEREVLON2a0ac6aa-0315-d79e-e063-6294a90a9c532024-12-24WarningsExact identifier
ndc (package): 10967-692-61
ndc (product): 10967-692
ndc11 (package): 10967069261
spl id: 2a0ac71c-e567-5ff9-e063-6394a90a4807
spl set id: 2a0ac6aa-0315-d79e-e063-6294a90a9c53

Reported adverse events (FAERS/openFDA)#

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