Home NDC 58411-905 cle de peau BEAUTE UV PROTECTIVE N
Product NDC 58411-905
11-digit product format 584110905
Labeler code 58411
Product ID 58411-905_34907910-b27e-0fee-e063-6294a90aecb7
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene
Dosage form CREAM
Route TOPICAL
Labeler Shiseido Americas Corporation
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-01
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 1201; 5225; 2612; 2612 mg/50mL; mg/50mL; mg/50mL; mg/50mL
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 N
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 1201 mg/50mL HOMOSALATE 5225 mg/50mL OCTISALATE 2612 mg/50mL OCTOCRYLENE 2612 mg/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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58411-905-60 cle de peau BEAUTE UV PROTECTIVE N 50 mL in 1 TUBE CREAM 50 2 58411-905-60 cle de peau BEAUTE UV PROTECTIVE N 1 in 1 BOX CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-905 CLE DE PEAU BEAUTE UV PROTECTIVE N (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [SHISEIDO AMERICAS CORPORATION] 2 Current NDC, 2 package rows 20250509_fe19a057-a3c6-4c53-92f9-a4a960cd5b08.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 58411-905-60 58411090560 1 TUBE in 1 BOX (58411-905-60) / 50 mL in 1 TUBE 1 tube 2025-04-01 No No Current