Home NDC 85625-212 Mineral Lip Sunscreen
Product NDC 85625-212
11-digit product format 856250212
Labeler code 85625
Product ID 85625-212_458bb39e-2e88-b4b4-e063-6394a90ae867
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-12
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 40; 55 mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Mineral Lip Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 40 mg/g ZINC OXIDE 55 mg/g
Harmonized Identifiers# Field, Values table Field Values Unii 15FIX9V2JP, SOI2LOH54Z
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 85625-212-45 Mineral Lip Sunscreen 4.5 g in 1 CYLINDER STICK 4.5 2 85625-212-45 Mineral Lip Sunscreen 1 in 1 CARTON STICK 1 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85625-212-45 85625021245 1 CYLINDER in 1 CARTON (85625-212-45) / 4.5 g in 1 CYLINDER 1 cylinder 2025-03-12 No No Current