Home NDC 58411-562 CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n
Product NDC 58411-562
11-digit product format 584110562
Labeler code 58411
Product ID 58411-562_47ba0253-c615-f775-e063-6294a90ae59d
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 2020-03-01
Substance AVOBENZONE; OCTINOXATE; OCTOCRYLENE; OXYBENZONE
Active strength .2472; .60564; .618; .2472 g/12mL; g/12mL; g/12mL; g/12mL
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 .2472 g/12mL OCTINOXATE .60564 g/12mL OCTOCRYLENE .618 g/12mL OXYBENZONE .2472 g/12mL
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 58411-562-10 CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n 1 in 1 CARTON EMULSION 1 4 58411-562-10 CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n 12 mL in 1 BOTTLE EMULSION 12 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-562 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_23bb4225-bfb5-47e2-80fe-733761ba4069.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 81 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 58411-562-10 58411056210 1 BOTTLE in 1 CARTON (58411-562-10) / 12 mL in 1 BOTTLE 1 bottle 2020-03-01 0000-00-00 No No Current