Home NDC 10967-676 ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR
Product NDC 10967-676
11-digit product format 109670676
Labeler code 10967
Product ID 10967-676_2a85bd43-4196-6ed7-e063-6294a90a84d4
Type HUMAN OTC DRUG
Nonproprietary name LIP PROTECTANT
Dosage form LIPSTICK
Route TOPICAL
Labeler REVLON CONSUMER PRODUCTS CORP
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-02-01
Substance PETROLATUM; OCTINOXATE; OXYBENZONE; AVOBENZONE
Active strength 1.147; .2775; .111; .074 g/3.7g; g/3.7g; g/3.7g; g/3.7g
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 ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 1.147 g/3.7g OCTINOXATE .2775 g/3.7g OXYBENZONE .111 g/3.7g AVOBENZONE .074 g/3.7g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10967-676-64 ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR 3.7 g in 1 TUBE LIPSTICK 3.7 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10967-676 ELIZABETH ARDEN EIGHT HR PROTECTANT CLEAR (LIP PROTECTANT) LIPSTICK [REVLON CONSUMER PRODUCTS CORP] 2 Current NDC, 1 package rows 20250101_f3a6fe29-7af7-bfb1-e053-2a95a90a0101.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 28 of 68 · 1,357 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10967-676-64 10967067664 3.7 g in 1 TUBE (10967-676-64) 3.7 g 2023-02-01 No No Current