Home NDC 58411-454 CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n
Product NDC 58411-454
11-digit product format 584110454
Labeler code 58411
Product ID 58411-454_47aa45d8-6669-112b-e063-6294a90a76fb
Type HUMAN OTC DRUG
Nonproprietary name avobenzone, octinoxate, octocrylene, and oxybenzone
Dosage form EMULSION
Route TOPICAL
Labeler SHISEIDO AMERICAS CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-02-01
Substance AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE
Active strength 3200; 9472; 2560; 1280 mg/125mL; mg/125mL; mg/125mL; mg/125mL
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 PROTECTIVE FORTIFYING n
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3200 mg/125mL OCTINOXATE 9472 mg/125mL OCTOCRYLENE 2560 mg/125mL OXYBENZONE 1280 mg/125mL
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 58411-454-10 CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n 125 mL in 1 CONTAINER EMULSION 125 3 58411-454-10 CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n 1 in 1 CARTON EMULSION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-454 CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING N (AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE) EMULSION [SHISEIDO AMERICAS CORPORATION] 2 Current NDC, Legacy NDC, 2 package rows 20241225_207e2035-5f31-4745-a801-b386b040b738.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 354 · 7,077 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 58411-454-10 58411045410 1 CONTAINER in 1 CARTON (58411-454-10) / 125 mL in 1 CONTAINER 1 container 2019-02-01 0000-00-00 No No Current