Home NDC 85334-212 SPF Lip
Product NDC 85334-212
11-digit product format 853340212
Labeler code 85334
Product ID 85334-212_45c8cda4-6b98-5f86-e063-6294a90acfea
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler Brent Loftis, D.O., Inc., A California Medical Corporation
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-19
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 SPF Lip
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 85334-212-45 SPF Lip 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 85334-212 SPF LIP (TITANIUM DIOXIDE, ZINC OXIDE) STICK [BRENT LOFTIS, D.O., INC., A CALIFORNIA MEDICAL CORPORATION] 1 Current NDC, 1 package rows 20250522_359297cd-10e2-6ddd-e063-6394a90a4aa0.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 85334-212-45 85334021245 4.5 g in 1 CYLINDER (85334-212-45) 4.5 g 2024-04-19 No No Current