Home NDC 85362-212 Tinted Lip Balm
Product NDC 85362-212
11-digit product format 853620212
Labeler code 85362
Product ID 85362-212_4603db8e-2444-c231-e063-6294a90a31bf
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form STICK
Route TOPICAL
Labeler Goldberg, Howard S MD Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-07
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 Tinted Lip Balm
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 85362-212-45 Tinted Lip Balm 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 85362-212 TINTED LIP BALM (TITANIUM DIOXIDE, ZINC OXIDE) STICK [GOLDBERG, HOWARD S MD INC] 1 Current NDC, 1 package rows 20250523_3598205d-2e87-9292-e063-6294a90a1f2a.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 85362-212-45 85362021245 4.5 g in 1 CYLINDER (85362-212-45) 4.5 g 2025-01-07 No No Current