FDA.reportPublic FDA data

ELIZABETH ARDEN EIGHT HOUR CREAM LIP PROTECTANT STICK SPF 15

Manufacturer
REVLON
Effective date
2024-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:14:38

Label at a glance#

ProductEIGHT HOUR LIP SPF 15
Active ingredientOXYBENZONE, PETROLATUM, PADIMATE O
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10967-679-612022-02-09C16284748780-1d6a99b39-9841-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM LIP PROTECTANT STICK SPF 15
10967-679-612022-01-28C16284748780-1d6a99b39-9841-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM LIP PROTECTANT STICK SPF 15

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-67910967-679-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
FERRIC OXIDE RED1K09F3G675IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TOCOPHEROLR0ZB2556P8IACT
CAPRYLYL GLYCOL00YIU5438UIACT
SOYBEAN OIL241ATL177AIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
CORN OIL8470G57WFMIACT
CITRALT7EU0O9VPPIACT
GERANIOLL837108USYIACT
LINALOOL, (+/-)-D81QY6I88EIACT
CARNAUBA WAXR12CBM0EIZIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
LANOLIN OILOVV5IIJ58FIACT
OXYBENZONE95OOS7VE0YACTIB
PETROLATUM4T6H12BN9UACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
CASTOR OILD5340Y2I9GIACT
CERESINQ1LS2UJO3AIACT
MYRISTYL LACTATE1D822OC34XIACT
CETYL ACETATE4Q43814HXSIACT
YELLOW WAX2ZA36H0S2VIACT
.BETA.-CITRONELLOL, (R)-P01OUT964KIACT
LIMONENE, (+)-GFD7C86Q1WIACT
GLYCERYL ROSINATESD112V492JIACT
CETYL LACTATEA7EVH2RK4OIACT
MYRISTYL ALCOHOLV42034O9PUIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
CANDELILLA WAXWL0328HX19IACT
ACETYLATED LANOLIN ALCOHOLSSNN716810PIACT
PADIMATE OZ11006CMUZACTIB

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
2a0a5f4d-e0da-1ddf-e063-6394a90a442ab3c2908a-bf68-99de-e053-2a95a90a6d6c2024-12-24WarningsExact identifier
spl set id: b3c2908a-bf68-99de-e053-2a95a90a6d6c

Reported adverse events (FAERS/openFDA)#

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