Home NDC 58411-653 cle de peau BEAUTE RADIANT FOUNDATION N
Product NDC 58411-653
11-digit product format 584110653
Labeler code 58411
Product ID 58411-653_47a78ab3-8ca0-3fcd-e063-6294a90a2c1f
Type HUMAN OTC DRUG
Nonproprietary name octinoxate and titanium dioxide
Dosage form EMULSION
Route TOPICAL
Labeler SHISEIDO AMERICAS CORPORATION
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-01
Substance OCTINOXATE; TITANIUM DIOXIDE
Active strength 1.07; .3 g/21mL; g/21mL
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 RADIANT FOUNDATION N
Brand name suffix BF50
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OCTINOXATE 1.07 g/21mL TITANIUM DIOXIDE .3 g/21mL
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 58411-653-60 cle de peau BEAUTE RADIANT FOUNDATION NBF50 1 in 1 CARTON EMULSION 1 3 58411-653-60 cle de peau BEAUTE RADIANT FOUNDATION NBF50 21 mL in 1 TUBE EMULSION 21 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58411-653 CLE DE PEAU BEAUTE RADIANT FOUNDATION N I10 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FOUNDATION N O10 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FOUNDATION N O40 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FOUNDATION N B40 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSI .......E DE PEAU BEAUTE RADIANT FOUNDATION N BF10 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF50 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FOUNDATION N BF60 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FOUNDATION N O20 (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION [SHISEIDO AMERICAS CORPORATION] 2 Current NDC, Legacy NDC, 2 package rows 20241225_05ffb157-5e28-4e94-866d-9e3371480d84.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 330 of 352 · 7,030 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Coral Safe SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 4925a507-863f-1088-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M020 CoralSafe Broad Spectrum SPF30 TITANIUM DIOXIDE, ZINC OXIDE Elements Brands e6e00896-b7e5-41c6-a72b-08e600758cf5 2023-11-10 Warnings Exact identifier application number: M020 Coral Safe SPF-30 Broad Spectrum Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Elements Brands, Inc. 4925a3ad-6379-108a-e054-00144ff8d46c 2023-11-10 Warnings Exact identifier application number: M020 BELASOL Sun Cream Non-Tinted Moisturizing SPF 50 TITANIUM DIOXIDE, ZINC OXIDE EK Clothing LLC dba Belasol fb677ad0-2791-44ec-9720-951471ec009a 2023-11-09 Warnings Exact identifier application number: M020 Banana Boat Deep Tanning Sunscreen SPF 4 AVOBENZONE,OCTISALATE Edgewell Personal Care Brands LLC ab8623e2-0539-3f8f-e053-2a95a90a39d5 2023-11-09 Warnings Exact identifier application number: M020 Shaklee Youth Age Defense Mineral Moisturizer SPF 30 TITANIUM DIOXIDE Shaklee Corporation f4888fdc-09f9-43de-8c81-5a0f5e767d4e 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Eco 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC bcce6d5b-d641-4484-a4dd-06b81170f863 2023-11-09 Warnings Exact identifier application number: M020 Spit and Polish Mineral Face SPF 30 ZINC OXIDE Naturally Uncommon, LLC af86fca8-571c-0cac-e053-2a95a90ae402 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Tint 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC 801a616a-5007-4951-8bc5-b8ffe9f0bb19 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Baby Kids Broad Spectrum SPF30 ZINC OXIDE Raw Elements LLC fda8fce8-a164-45b5-b6ca-b1efce474089 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Lip Rescue 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC 74b8eac3-4bc6-430b-b4b9-eabe3280d7af 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Baby Kids Broad Spectrum SPF30 Sunscreen ZINC OXIDE Raw Elements LLC a6e5f808-65c7-4810-a15c-413111216dae 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Eco Formula 30 Broad Spectrum SPF 30 ZINC OXIDE Raw Elements LLC 1d130543-9e12-42f4-80b4-915dbe0f85d4 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Facial Moisturizer Tint Formula 30 SPF 30 Broad Spectrum ZINC OXIDE Raw Elements LLC 8aff5517-8b3d-490e-b821-973baea2d079 2023-11-09 Warnings Exact identifier application number: M020 Raw Elements Daily Moisturizer Broad Spectrum SPF30 ZINC OXIDE Raw Elements LLC 92c5f11b-5585-4479-8ee3-315c7e72574f 2023-11-09 Warnings Exact identifier application number: M020 Big Mood SPF 30 Milky Lip Balm ZINC OXIDE Everyday Group Limited c83098af-3cf9-78f6-e053-2995a90a0d01 2023-11-09 Warnings Exact identifier application number: M020 Spit and Polish Sun Smart Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Naturally Uncommon, LLC af879a05-1483-5c11-e053-2995a90af45d 2023-11-09 Warnings Exact identifier application number: M020 Spit and Polish Mineral Lip Balm Broad Spectrum Lip Protectant SPF 30 ZINC OXIDE Naturally Uncommon, LLC af882b7e-c64f-0de6-e053-2995a90a7ca0 2023-11-09 Warnings Exact identifier application number: M020 EltaMD UV AOX Mist ZINC OXIDE SUNSCREEN CP Skin Health Group, Inc 1062efb1-a638-4323-88f8-f2f98a5b996e 2023-11-09 Warnings Exact identifier application number: M020 EltaMD UV Active ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN CP Skin Health Group, Inc. 2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd2 2023-11-09 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58411-653-60 58411065360 1 TUBE in 1 CARTON (58411-653-60) / 21 mL in 1 TUBE 1 tube 2021-05-01 0000-00-00 No No Current