Home NDC 10967-692 EIGHT HOUR LIP PROTECTANT SPF 15
Product NDC 10967-692
11-digit product format 109670692
Labeler code 10967
Product ID 10967-692_2a0ac71c-e567-5ff9-e063-6394a90a4807
Type HUMAN OTC DRUG
Nonproprietary name PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE
Dosage form LIPSTICK
Route TOPICAL
Labeler REVLON
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-11-01
Substance AVOBENZONE; OCTINOXATE; OXYBENZONE; PETROLATUM
Active strength 2; 7.49475; 3; 30.99938 mg/g; 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 EIGHT HOUR LIP PROTECTANT SPF 15
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 2 mg/g OCTINOXATE 7.49475 mg/g OXYBENZONE 3 mg/g PETROLATUM 30.99938 mg/g
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 10967-692-61 EIGHT HOUR LIP PROTECTANT SPF 15 3.7 g in 1 CARTRIDGE LIPSTICK 3.7 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10967-692 EIGHT HOUR LIP PROTECTANT SPF 15 (PETROLATUM, OXYBENZONE, OCTINOXATE, AVOBENZONE) LIPSTICK [REVLON] 1 Current NDC, 1 package rows 20241226_2a0ac6aa-0315-d79e-e063-6294a90a9c53.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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 10967-692-61 10967069261 3.7 g in 1 CARTRIDGE (10967-692-61) 3.7 g 2021-11-01 No No Current