Home NDC 58411-856 cle de peau BEAUTE PROTECTIVE LIP TREATMENT
Product NDC 58411-856
11-digit product format 584110856
Labeler code 58411
Product ID 58411-856_47a7a718-ae9f-4001-e063-6294a90a8857
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, OCTINOXATE, and OCTOCRYLENE
Dosage form EMULSION
Route TOPICAL
Labeler SHISEIDO AMERICAS CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-08-01
Substance AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength 100; 196; 120 mg/4g; mg/4g; mg/4g
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 LIP TREATMENT
Brand name suffix SPF 25
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 100 mg/4g OCTINOXATE 196 mg/4g OCTOCRYLENE 120 mg/4g
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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58411-856-10 cle de peau BEAUTE PROTECTIVE LIP TREATMENTSPF 25 4 g in 1 BOTTLE, GLASS EMULSION 4 3 58411-856-20 cle de peau BEAUTE PROTECTIVE LIP TREATMENTSPF 25 1 in 1 BOX EMULSION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-856 CLE DE PEAU BEAUTE PROTECTIVE LIP TREATMENT SPF 25 (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) EMULSION [SHISEIDO AMERICAS CORPORATION] 2 Current NDC, 2 package rows 20241225_addd9885-362c-4ce0-9a6e-759e71d8756c.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 124 of 354 · 7,077 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Matte Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE EDIT EUROSPA, LLC 3751544d-e093-3d19-e063-6394a90aefc3 2025-12-15 Exact identifier application number: M020 Lip Crack TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37edc05c-82c3-90fe-e063-6294a90aa601 2025-12-15 Exact identifier application number: M020 Restore And Replenish ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37ed8525-6ae4-4e86-e063-6294a90afeb8 2025-12-15 Exact identifier application number: M020 Sunshade Daily Sun Defense TITANIUM DIOXIDE, ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37ee77dc-a96a-5efa-e063-6394a90affda 2025-12-15 Exact identifier application number: M020 Sunshade Mineral Sunscreen ZINC OXIDE BELLAGENA SKINCARE STUDIO & SPA 37df21f1-f36f-df43-e063-6294a90aea6f 2025-12-15 Exact identifier application number: M020 Tinted Moisturizing Mineral Sunscreen ZINC OXIDE EDIT EUROSPA, LLC 3751861d-3f3b-2ebd-e063-6294a90af898 2025-12-15 Exact identifier application number: M020 Non Tinted Moisturizing Mineral Sunscreen ZINC OXIDE EDIT EUROSPA, LLC 3751e278-b8b2-7bf4-e063-6394a90a4290 2025-12-15 Exact identifier application number: M020 Tinted Mineral Sunscreen Stick TITANIUM DIOXIDE, ZINC OXIDE EDIT EUROSPA, LLC 37521c60-2fee-861e-e063-6294a90ad69a 2025-12-15 Exact identifier application number: M020 MATTE Non Tinted Mineral Sunscreen ZINC OXIDE Allure Esthetics 3725d947-b1fa-3b50-e063-6394a90adf10 2025-12-15 Exact identifier application number: M020 GLOW Tinted Mineral Sunscreen ZINC OXIDE Allure Esthetics 37257bb2-d91d-6ff8-e063-6294a90a01b6 2025-12-15 Exact identifier application number: M020 Daily Restore ZINC OXIDE TYRLIN ENTERPRISES, INC. 35ce7133-badb-1bc4-e063-6294a90a7478 2025-12-15 Exact identifier application number: M020 20Percent Zinc Oxide Sunscreen ZINC OXIDE Minder Day Spa, Inc. 35bee5f9-68d6-6302-e063-6394a90ada88 2025-12-15 Exact identifier application number: M020 20Percent Zinc Oxide Sunscreen ZINC OXIDE Minder Day Spa, Inc. 35bfd54a-d7b7-f1a7-e063-6294a90a039b 2025-12-15 Exact identifier application number: M020 AM RESTORE ZINC OXIDE Minder Day Spa, Inc. 35c03804-04e9-3d54-e063-6294a90a3407 2025-12-15 Exact identifier application number: M020 Deflectin Tinted Mineral Sunscreen ZINC OXIDE AEON AESTHETICS LLC 35d14660-8900-2cb0-e063-6394a90a317d 2025-12-15 Exact identifier application number: M020 Mineral Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf36c1-50c9-e848-e063-6294a90a6658 2025-12-15 Exact identifier application number: M020 Flash Invisible Stick TITANIUM DIOXIDE, ZINC OXIDE AEON AESTHETICS LLC 35d2489e-4978-4fc3-e063-6294a90adfcc 2025-12-15 Exact identifier application number: M020 AM RESTORE ZINC OXIDE Minder Day Spa, Inc. 35c010ad-e25d-f197-e063-6294a90a0efb 2025-12-15 Exact identifier application number: M020 Flash Tinted Stick TITANIUM DIOXIDE, ZINC OXIDE AEON AESTHETICS LLC 35d28590-e746-7996-e063-6294a90ac7d8 2025-12-15 Exact identifier application number: M020 Mineral Tinted Sunscreen TITANIUM DIOXIDE, ZINC OXIDE JADEIA LIMITED INC 35cf03f4-200a-5643-e063-6394a90a9e02 2025-12-15 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 58411-856-10 58411085610 4 g in 1 BOTTLE, GLASS 4 g Historical 58411-856-20 58411085620 1 BOTTLE, GLASS in 1 BOX (58411-856-20) / 4 g in 1 BOTTLE, GLASS (58411-856-10) 2022-08-01 No No Current