Home NDC 58411-953 cle de peau BEAUTE Protective Day
Product NDC 58411-953
11-digit product format 584110953
Labeler code 58411
Product ID 58411-953_4ba70b99-a469-5452-e063-6294a90ae3bd
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Octinoxate, Octocrylene
Dosage form EMULSION
Route TOPICAL
Labeler Shiseido Americas Corporation
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-02
Substance AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength 3.25; 6.38; 6.51 g/125mL; g/125mL; g/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 Day
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 3.25 g/125mL OCTINOXATE 6.38 g/125mL OCTOCRYLENE 6.51 g/125mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G63QQF2NOX Internal UNII lookup 4Y5P7MUD51 Internal UNII lookup 5A68WGF6WM Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58411-953-10 cle de peau BEAUTE Protective Day 125 mL in 1 BOTTLE, GLASS EMULSION 125 4 58411-953-10 cle de peau BEAUTE Protective Day 1 in 1 BOX EMULSION 1 4 58411-953-11 cle de peau BEAUTE Protective Day 12 mL in 1 BOTTLE, PLASTIC EMULSION 12 4 58411-953-11 cle de peau BEAUTE Protective Day 1 in 1 BOX EMULSION 1 4 58411-953-12 cle de peau BEAUTE Protective Day 1 in 1 BOX EMULSION 1 4 58411-953-12 cle de peau BEAUTE Protective Day 5 mL in 1 BOTTLE, PLASTIC EMULSION 5 4
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 Marketing start Sample Exclude flag Status 58411-953-10 58411095310 1 BOTTLE, GLASS in 1 BOX (58411-953-10) / 125 mL in 1 BOTTLE, GLASS 2025-12-11 No No Current 58411-953-11 58411095311 1 BOTTLE, PLASTIC in 1 BOX (58411-953-11) / 12 mL in 1 BOTTLE, PLASTIC 2025-02-02 No No Current 58411-953-12 58411095312 1 BOTTLE, PLASTIC in 1 BOX (58411-953-12) / 5 mL in 1 BOTTLE, PLASTIC 2025-02-02 No No Current