Home NDC 85413-212 Mineral Lip Sunscreen
Product NDC 85413-212
11-digit product format 854130212
Labeler code 85413
Product ID 85413-212_45b3b0ef-0939-2a47-e063-6294a90aea60
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler HALEM DERMATOLOGY PLLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-11
Substance ZINC OXIDE; TITANIUM DIOXIDE
Active strength 55; 40 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 Mineral Lip Sunscreen
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 55 mg/g TITANIUM DIOXIDE 40 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup 15FIX9V2JP 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 85413-212-45 Mineral Lip Sunscreen 1 in 1 CYLINDER STICK 1 2 85413-212-45 Mineral Lip Sunscreen 4.5 g in 1 CYLINDER STICK 4.5 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 85413-212 MINERAL LIP SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) STICK [HALEM DERMATOLOGY PLLC] 1 Current NDC, 2 package rows 20250524_35bce44e-d9f4-9279-e063-6394a90a6453.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 354 · 7,077 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 85413-212-45 85413021245 1 CYLINDER in 1 CYLINDER (85413-212-45) / 4.5 g in 1 CYLINDER 1 cylinder 2023-01-11 No No Current