FDA.reportPublic FDA data

EIGHT HOUR NOURISHING LIP SPF 20

Manufacturer
REVLON | Englewood Lab. INC.
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:29:25

Label at a glance#

ProductEIGHT HOUR NOURISHING LIP SPF 20
Active ingredientOCTINOXATE, AVOBENZONE
Label structure11 sections

Indications and uses

Uses - Helps prevent sunburn - If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Directions For Sunscreen Use: - Apply liberally 15 minutes before sun exposure - Reapply: - at least every 2 hours - Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: - Limit time in the sun, especially from 10 a.m. – 2 p.m....

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose
OCTINOXATE 4.0%...................................................Sunscreen
AV0BENZONE 3.0%..................................................Sunscreen

Inactive Ingredients

INACTIVE INGREDIENT SECTION

POLYBUTENE, MICROCRYSTALLINE WAX/CERA MICROCRISTALLINA/CIRE MICROCRISTALLINE, PETROLATUM, RICINUS COMMUNIS (CASTOR) SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, NYLON-12, DIOCTYLDODECYL DODECANEDIOATE, C12-15 ALKYL BENZOATE, GLYCERETH-26, BUTYLOCTYL SALICYLATE, LANOLIN, ASTROCARYUM MURUMURU SEED BUTTER, BEESWAX/CERA ALBA/CIRE D'ABEILLE, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HONEY EXTRACT, HYDROGENATED CASTOR OIL, LINOLEIC ACID, LINOLENIC ACI, NASTURTIUM OFFICINALE FLOWER/LEAF EXTRACT, RETINYL PALMITATE, TO DCOPHEROL, TOCOPHERYL ACETATE, BHT, IRON OXIDES (CI 77491, CI 77492).

Uses

INSTRUCTIONS FOR USE SECTION

Uses
- Helps prevent sunburn

- If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

SAFE HANDLING WARNING SECTION

Warnings
- For external use only

- Do not use on damaged or broken skin

- When using this product keep out of eyes. Rinse with water to remove.
- Stop use and ask a doctor if rash occurs

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

Directions For Sunscreen Use

OTC - WHEN USING SECTION

Directions For Sunscreen Use:
- Apply liberally 15 minutes before sun exposure
- Reapply:

- at least every 2 hours
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m. – 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses

- Children under 6 months: Ask a doctor.

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin againg caused by the sun

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.

OTC - PURPOSE SECTION

Sunscreen

WARNINGS SECTION

  • For external use only.
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes. Rinse with water to remove.
  • Stop using and ask a doctor if rash occurs.

CARTON ART

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NOURISHING LIPNOURISHING LIP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130012345678905GTIN-13: 0012345678905
EAN-13: 0012345678905
GTIN-12: 012345678905
UPC-A: 012345678905
GTIN storage (14 digits): 00012345678905		EIGN00120 DRUG FACTS.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10967-671-612025-12-29C16284748780-1d6a99b39-982c-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM NOURISHING LIP BALM BROAD SPECTRUM SUNSCREEN SPF 20
10967-671-612023-07-28C16284748780-1d6a99b39-982c-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM NOURISHING LIP BALM BROAD SPECTRUM SUNSCREEN SPF 20
10967-671-612022-02-09C16284748780-1d6a99b39-982c-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM NOURISHING LIP BALM BROAD SPECTRUM SUNSCREEN SPF 20
10967-671-612022-01-28C16284748780-1d6a99b39-982c-a426-e053-dadaa90af4c2ELIZABETH ARDEN EIGHT HOUR CREAM NOURISHING LIP BALM BROAD SPECTRUM SUNSCREEN SPF 20

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-671-61EIGHT HOUR NOURISHING LIP SPF 2014.2 g in 1 TUBE, WITH APPLICATOREMULSION14.23

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-67110967-671-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
AVOBENZONEG63QQF2NOXACTIB
POLYBUTENE (1400 MW)1NA5AO9GH7IACT
CASTOR OILD5340Y2I9GIACT
NYLON-12446U8J075BIACT
SUNFLOWER OIL3W1JG795YIIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
FERRIC OXIDE RED1K09F3G675IACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ASTROCARYUM MURUMURU SEED BUTTER12V64UPU6RIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
LANOLIN7EV65EAW6HIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
SHEA BUTTERK49155WL9YIACT
GLYCERETH-26NNE56F2N14IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
LINOLEIC ACID9KJL21T0QJIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
YELLOW WAX2ZA36H0S2VIACT
HONEYY9H1V576FHIACT
LINOLENIC ACID0RBV727H71IACT
TOCOPHEROLR0ZB2556P8IACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PETROLATUM4T6H12BN9UIACT
DIOCTYLDODECYL DODECANEDIOATE7QDB5EE79YIACT

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 NOURISHING LIP SPF 20OCTINOXATE, AVOBENZONEREVLONb3c16e60-752d-6eba-e053-2995a90a2b202025-12-29WarningsExact identifier
ndc (package): 10967-671-61
ndc (product): 10967-671
ndc11 (package): 10967067161
spl id: 471d7db4-fbd2-4509-e063-6394a90a02a6
spl set id: b3c16e60-752d-6eba-e053-2995a90a2b20

Reported adverse events (FAERS/openFDA)#

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