EA EIGHT HR LIP SHEER TINTS

Manufacturer
REVLON
Effective date
2024-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:10

Label at a glance#

ProductEA EIGHT HR LIP SHEER TINTS
Active ingredientPADIMATE O, PETROLATUM, OXYBENZONE
Label structure10 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: ■ at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating ■ children under 6 months: Ask a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

OCTINOXATE 7.5%...................Sunscreen
OXYBENZONE 3.0%.................Sunscreen
AVOBENZONE 2.0%.................Sunscreen

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

POLYBUTENE, BIS-DIGLYCERYL POLYACYLADIPATE-2, DIISOSTEARYL MALATE, POLYETHYLENE, OZOKERITE, LANOLIN, OCTYLDODECYL NEOPENTANOATE, HYDROGENATED POLYISOBUTENE, SYNTHETIC FLUORPHLOGOPITE, CETYL
PEG/PPG-10/1 DIMETHICONE, HEXYL LAURATE, POLYGLYCERYL-4 ISOSTEARATE, SYNTHETIC WAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, CERA ALBA (BEESWAX (CIRE D’ABEILLE)), COCOS NUCIFERA (COCONUT) OIL, TOCOPHERYL ACETATE, PARFUM (FRAGRANCE), BENZOIC ACID, CITRONELLOL, GERANIOL, LIMONENE, LINALOOL, BHT,

MAY CONTAIN: IRON OXIDES (CI 77491, CI 77499), MICA, RED 33 LAKE (CI 17200), RED 6 LAKE (CI 15850), RED 7 LAKE (CI 15850), TITANIUM DIOXIDE (CI 77891), YELLOW 5 LAKE (CI 19140).

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

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

DIRECTIONS

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
■ use a water resistant sunscreen if swimming or sweating
■ children under 6 months: Ask a doctor.

DOSAGE & ADMINISTRATION SECTION

As needed

INDICATIONS & USAGE SECTION

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

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

Skin Protectant

CARTON ART

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8HR TINTED8HR TINTED

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10967-674-612022-02-09C16284748780-1d6a99b39-80de-a426-e053-dadaa90af4c2EA 8Hr Lip Protectant Stick Sheer Tints
10967-674-612022-01-28C16284748780-1d6a99b39-80de-a426-e053-dadaa90af4c2EA 8Hr Lip Protectant Stick Sheer Tints

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-674-61EA EIGHT HR LIP SHEER TINTS3.7 g in 1 CARTRIDGELIPSTICK3.73

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-674EA EIGHT HR LIP SHEER TINTS (OXYBENZONE, PADIMATE O, PETROLATUM) LIPSTICK [REVLON]3Current NDC, Legacy NDC, 1 package rows20240113_b671d630-2b71-66d2-e053-2a95a90a8461.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-67410967-674-61

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

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
EA EIGHT HR LIP SHEER TINTSOXYBENZONE, PADIMATE O, PETROLATUMREVLONb671d630-2b71-66d2-e053-2a95a90a84612024-01-12WarningsExact identifier
ndc (package): 10967-674-61
ndc (product): 10967-674
ndc11 (package): 10967067461
spl id: 0ec6e2a3-5c58-477b-e063-6294a90a8fd0
spl set id: b671d630-2b71-66d2-e053-2a95a90a8461

Reported adverse events (FAERS/openFDA)#

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