Home NDC 85403-212 Deluxe Lip Protection
Product NDC 85403-212
11-digit product format 854030212
Labeler code 85403
Product ID 85403-212_46036c73-6783-31af-e063-6394a90a150a
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler BIOHEALTH PLUS LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-06-10
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 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 Deluxe Lip Protection
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 40 mg/g ZINC OXIDE 55 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 15FIX9V2JP Internal UNII lookup SOI2LOH54Z Internal UNII lookup
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 85403-212-45 Deluxe Lip Protection 4.5 g in 1 CYLINDER STICK 4.5 2 85403-212-45 Deluxe Lip Protection 1 in 1 CARTON STICK 1 2
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 85403-212-45 85403021245 1 CYLINDER in 1 CARTON (85403-212-45) / 4.5 g in 1 CYLINDER 1 cylinder 2022-06-10 No No Current