Home NDC 53634-128 spf 30 mineral Sunscreen
Product NDC 53634-128
11-digit product format 536340128
Labeler code 53634
Product ID 53634-128_5d3489bc-d49b-289c-e063-6294a90a49fc
Type HUMAN OTC DRUG
Nonproprietary name Titanium Dioxide, Zinc Oxide
Dosage form CREAM
Route TOPICAL
Labeler Malin and Goetz Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-12-15
Substance TITANIUM DIOXIDE; ZINC OXIDE
Active strength 3.71; 2.71 g/100mL; 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 mineral Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TITANIUM DIOXIDE 3.71 g/100mL ZINC OXIDE 2.71 g/100mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53634-128-01 spf 30 mineral Sunscreen 50 mL in 1 TUBE CREAM 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53634-128 SPF 30 MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MALIN AND GOETZ INC] 2 Current NDC, 1 package rows 20241004_f3d39df9-1618-7014-e053-2995a90af7bb.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 53634-128-01 53634012801 50 mL in 1 TUBE (53634-128-01) 50 ml 2022-12-15 No No Current