Home NDC 58411-480 SHISEIDO ULTIMATE SUN PROTECTOR
Product NDC 58411-480
11-digit product format 584110480
Labeler code 58411
Product ID 58411-480_47a95b3e-c698-9007-e063-6394a90afe66
Type HUMAN OTC DRUG
Nonproprietary name OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, and ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler SHISEIDO AMERICAS CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-01-01
Substance OCTISALATE; TITANIUM DIOXIDE; OCTOCRYLENE; ZINC OXIDE
Active strength 3.105; 2.359; 4.347; 12.047 g/50mL; g/50mL; g/50mL; g/50mL
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 SHISEIDO ULTIMATE SUN PROTECTOR
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTISALATE 3.105 g/50mL TITANIUM DIOXIDE 2.359 g/50mL OCTOCRYLENE 4.347 g/50mL ZINC OXIDE 12.047 g/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58411-480-60 SHISEIDO ULTIMATE SUN PROTECTOR 1 in 1 CARTON CREAM 1 3 58411-480-60 SHISEIDO ULTIMATE SUN PROTECTOR 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 58411-480 SHISEIDO ULTIMATE SUN PROTECTOR (OCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDE) CREAM [SHISEIDO AMERICAS CORPORATION] 2 Current NDC, Legacy NDC, 2 package rows 20241225_c656792a-e1ed-478d-b501-9bdc92d16eca.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 Marketing end Sample Exclude flag Status 58411-480-60 58411048060 1 TUBE in 1 CARTON (58411-480-60) / 50 mL in 1 TUBE 1 tube 2020-01-01 0000-00-00 No No Current