Home NDC 58411-971 SHISEIDO ULTIMATE SUN PROTECTOR
Product NDC 58411-971
11-digit product format 584110971
Labeler code 58411
Product ID 58411-971_4a041a52-40c7-099d-e063-6394a90a766e
Type HUMAN OTC DRUG
Nonproprietary name OCTISALATE, OCTOCRYLENE, ZINC OXIDE
Dosage form CREAM
Route TOPICAL
Labeler Shiseido Americas Corporation
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-01
Substance OCTOCRYLENE; OCTISALATE; ZINC OXIDE
Active strength 1.8105; 1.8105; 11.7079 g/50mL; g/50mL; g/50mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 OCTOCRYLENE 1.8105 g/50mL OCTISALATE 1.8105 g/50mL ZINC OXIDE 11.7079 g/50mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5A68WGF6WM Internal UNII lookup 4X49Y0596W 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 58411-971-60 SHISEIDO ULTIMATE SUN PROTECTOR 1 in 1 BOX CREAM 1 2 58411-971-60 SHISEIDO ULTIMATE SUN PROTECTOR 50 mL in 1 TUBE CREAM 50 2
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 45 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 58411-971-60 58411097160 1 TUBE in 1 BOX (58411-971-60) / 50 mL in 1 TUBE 1 tube 2025-03-01 No No Current