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 167 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Well People Bio Tint SPF 30 Sunscreen 12w ZINC OXIDE e.l.f. Cosmetics, Inc c8a99278-21e0-c517-e053-2a95a90ade37 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 1C ZINC OXIDE e.l.f. Cosmetics, Inc c8a82c8b-e308-15e9-e053-2995a90afa2a 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 14w ZINC OXIDE e.l.f. Cosmetics, Inc c8aa4629-1573-48a7-e053-2995a90aa86c 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 2w ZINC OXIDE e.l.f. Cosmetics, Inc. c8a82f54-839d-1de0-e053-2a95a90a2a97 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 4W ZINC OXIDE e.l.f. Cosmetics, Inc c8a83921-3181-396e-e053-2a95a90a02ee 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 3N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce3e-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 5N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce42-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 6w ZINC OXIDE e.l.f. Cosmetics, Inc c8a8ef6f-4426-a981-e053-2a95a90a9451 2025-11-07 Warnings Exact identifier application number: M020 Well People Lip Butter SPF 15 Sunscreen PEACH ZINC OXIDE e.l.f. Cosmetics, Inc c8aa931b-a3b4-6804-e053-2995a90a3eab 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 7N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa6047-ce45-59f7-e053-2a95a90a678e 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 8N ZINC OXIDE e.l.f. Cosmetics, Inc c8aa662c-0f06-712b-e053-2995a90aae0b 2025-11-07 Warnings Exact identifier application number: M020 Well People Lip Butter SPF 15 Sunscreen AFTERGLOW ZINC OXIDE e.l.f. Cosmetics, Inc c8aa9325-4fad-ddf9-e053-2a95a90a6639 2025-11-07 Warnings Exact identifier application number: M020 Well People Bio Tint SPF 30 Sunscreen 9w ZINC OXIDE e.l.f. Cosmetics, Inc c8a92c58-d981-0948-e053-2a95a90a16f8 2025-11-07 Warnings Exact identifier application number: M020 Well People Lip Butter SPF 15 Sunscreen WINE ZINC OXIDE e.l.f. Cosmetics, Inc c8aa873e-8271-8cf0-e053-2995a90a3cec 2025-11-07 Warnings Exact identifier application number: M020 Well People Lip Butter SPF 15 Sunscreen NATURAL ZINC OXIDE e.l.f. Cosmetics, Inc c8aa7ae9-7d03-db7d-e053-2995a90ae72b 2025-11-07 Warnings Exact identifier application number: M020 Neutrogena Clear Face Serum Fragrance Free SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Kenvue Brands LLC eb705402-f8cb-5079-e053-2a95a90a405c 2025-11-06 Warnings Exact identifier application number: M020 Neutrogena Cool Dry Sport Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 5c1a0437-c269-4cd3-b91a-e2de799b853e 2025-11-06 Warnings Exact identifier application number: M020 Neutrogena Clear Face Breakout Free oil Free Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 10ca67ca-c372-44a9-8933-84cce9fb9934 2025-11-06 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0464448b-342b-4e54-a20e-6ec6bd622889 2025-11-06 Warnings Exact identifier application number: M020 Neutrogena Hydro Boost Water Gel Sunscreen Broad Spectrum SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 7f60d6bd-1735-4390-bc8a-e3876ab7ad50 2025-11-06 Warnings Exact identifier application number: M020
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