Home NDC 10967-674 EA EIGHT HR LIP SHEER TINTS
Product NDC 10967-674
11-digit product format 109670674
Labeler code 10967
Product ID 10967-674_0ec6e2a3-5c58-477b-e063-6294a90a8fd0
Type HUMAN OTC DRUG
Nonproprietary name OXYBENZONE, PADIMATE O, PETROLATUM
Dosage form LIPSTICK
Route TOPICAL
Labeler REVLON
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-04-17
Substance PADIMATE O; PETROLATUM; OXYBENZONE
Active strength 8; 30.2; 3 mg/g; mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base EA EIGHT HR LIP SHEER TINTS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PADIMATE O 8 mg/g PETROLATUM 30.2 mg/g OXYBENZONE 3 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z11006CMUZ Internal UNII lookup 4T6H12BN9U Internal UNII lookup 95OOS7VE0Y Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10967-674-61 EA EIGHT HR LIP SHEER TINTS 3.7 g in 1 CARTRIDGE LIPSTICK 3.7 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10967-674 EA EIGHT HR LIP SHEER TINTS (OXYBENZONE, PADIMATE O, PETROLATUM) LIPSTICK [REVLON] 3 Current NDC, Legacy NDC, 1 package rows 20240113_b671d630-2b71-66d2-e053-2a95a90a8461.zip
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 81 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10967-674-61 10967067461 3.7 g in 1 CARTRIDGE (10967-674-61) 3.7 g 2019-04-17 0000-00-00 No No Current