Home NDC 58411-005 cle de peau BEAUTE THE FOUNDATION N M
Product NDC 58411-005
11-digit product format 584110005
Labeler code 58411
Product ID 58411-005_4b9306fc-0dca-4458-e063-6394a90acf85
Type HUMAN OTC DRUG
Nonproprietary name OCTINOXATE and TITANIUM DIOXIDE
Dosage form PASTE
Route TOPICAL
Labeler Shiseido Americas Corporation
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-02
Substance OCTINOXATE; TITANIUM DIOXIDE
Active strength 1.165; .986 g/28mL; g/28mL
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 cle de peau BEAUTE THE FOUNDATION N M
Brand name suffix O80
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 1.165 g/28mL TITANIUM DIOXIDE .986 g/28mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4Y5P7MUD51 Internal UNII lookup 15FIX9V2JP 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 58411-005-10 cle de peau BEAUTE THE FOUNDATION N MO80 1 in 1 BOX PASTE 1 2 58411-005-10 cle de peau BEAUTE THE FOUNDATION N MO80 28 mL in 1 JAR PASTE 28 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 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 58411-005-10 58411000510 1 JAR in 1 BOX (58411-005-10) / 28 mL in 1 JAR 1 jar 2024-12-02 No No Current