Home NDC 58411-956 cle de peau BEAUTE UV PROTECTIVE FOR BODY N
Product NDC 58411-956
11-digit product format 584110956
Labeler code 58411
Product ID 58411-956_4617e90c-d282-21f4-e063-6294a90a5c41
Type HUMAN OTC DRUG
Nonproprietary name Ensulizole, Octisalate, Octocrylene, Zinc Oxide
Dosage form EMULSION
Route TOPICAL
Labeler Shiseido Americas Corporation
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-16
Substance ENSULIZOLE; OCTISALATE; OCTOCRYLENE; ZINC OXIDE
Active strength 2.384; 5.96; 5.96; 23.1248 g/100mL; g/100mL; g/100mL; g/100mL
Pharmacologic classes Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 cle de peau BEAUTE UV PROTECTIVE FOR BODY N
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ENSULIZOLE 2.384 g/100mL OCTISALATE 5.96 g/100mL OCTOCRYLENE 5.96 g/100mL ZINC OXIDE 23.1248 g/100mL
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58411-956-40 cle de peau BEAUTE UV PROTECTIVE FOR BODY N 1 in 1 BOX EMULSION 1 3 58411-956-40 cle de peau BEAUTE UV PROTECTIVE FOR BODY N 100 mL in 1 CONTAINER EMULSION 100 3
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 81 of 353 · 7,049 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 58411-956-40 58411095640 1 CONTAINER in 1 BOX (58411-956-40) / 100 mL in 1 CONTAINER 1 container 2025-12-16 No No Current