Home NDC 53634-129 spf 30 Lip Balm
Product NDC 53634-129
11-digit product format 536340129
Labeler code 53634
Product ID 53634-129_5d348531-6f3f-22fc-e063-6294a90a0986
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide
Dosage form STICK
Route TOPICAL
Labeler Malin and Goetz Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-05-01
Substance TITANIUM DIOXIDE
Active strength 3.3 g/100mL
NDC exclude flag No
Listing certified through 2027-12-31
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 30 Lip Balm
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 3.3 g/100mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53634-129-01 spf 30 Lip Balm 10 mL in 1 TUBE STICK 10 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53634-129 SPF 30 LIP BALM (TITANIUM DIOXIDE) STICK [MALIN AND GOETZ INC] 2 Current NDC, 1 package rows 20241004_fe1b3122-b6e2-46fa-e053-6394a90afd59.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 53634-129-01 53634012901 10 mL in 1 TUBE (53634-129-01) 10 ml 2023-05-01 No No Current