FDA.reportPublic FDA data

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
IngredientStrength
OCTINOXATE1.07 g/21mL
TITANIUM DIOXIDE.3 g/21mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
15FIX9V2JPInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
05ffb157-5e28-4e94-866d-9e3371480d84Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-653-60cle de peau BEAUTE RADIANT FOUNDATION NBF501 in 1 CARTONEMULSION13
58411-653-60cle de peau BEAUTE RADIANT FOUNDATION NBF5021 mL in 1 TUBEEMULSION213

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-653CLE 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]2Current NDC, Legacy NDC, 2 package rows20241225_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 333 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PROJECT REEF SPF-50ZINC OXIDE, TITANIUM DIOXIDEProject Reef LLC6bcd470c-6994-4d28-8370-4cc9d68e1e782023-11-06WarningsExact identifier
application number: M020
BB OSKIN Broad Spectrum SPF-30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NYd84cca38-b673-484e-aa25-df58d904d4d32023-11-06WarningsExact identifier
application number: M020
MIAMI MD SUN SHIELD Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBRAND BOLT LLC3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd2023-11-06WarningsExact identifier
application number: M020
JOY SPRING Kids Mineral Sunscreen SPF-30ZINC OXIDEJOYSPRING HOLDINGS LLC76613a3d-f4a8-4961-b36a-d84b4e10dea02023-11-06WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE HOMOSALATE OCTOCRYLENEEdgewell Personal Care Brands, LLC0fda2f46-4322-1284-e054-00144ff8d46c2023-11-06WarningsExact identifier
application number: M020
Aruba Aloe Sport Line Lip Balm Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAruba Aloe Balm NV80461b6d-b1b7-4220-894d-8bd4259094742023-11-06WarningsExact identifier
application number: M020
Sport Broad Spectrum SPF50 Water Resistant 80 minutes Mineral Sunscreen UVA UVB Protection StickZINC OXIDEAruba Aloe Balm NV3201cc8b-5fee-4f3b-a826-e349786d1b322023-11-06WarningsExact identifier
application number: M020
Broad Spectrum SPF50 Water Resistant (80 minutes) Mineral Sunscreen UVA UVB Protection Stick for KidsZINC OXIDEAruba Aloe Balm NV25f060eb-628c-4a11-b1d7-06922ee86b242023-11-06WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.44321dff-1a61-452f-8324-6de2a196db512023-11-06WarningsExact identifier
application number: M020
SPF30 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCITSALATEZhejiang Ayan Biotech Co., Ltd.cac6f5e5-91c2-4978-bffd-5ca2a75906372023-11-06WarningsExact identifier
application number: M020
SPF15 SunscreenAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.68035415-47c3-4eed-93f4-bb6b26c9149a2023-11-06WarningsExact identifier
application number: M020
SPF30 Sunscreen and Antibacterial Hand SanitizerALCOHOL, AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co., Ltd.b5e2458f-8e84-4e57-b6f7-e428a94c97a42023-11-06WarningsExact identifier
application number: M020
SPF30 Sunscreen and SPF15AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATEZhejiang Ayan Biotech Co.,Ltd.6c40259b-565a-46d0-90d0-ccc1867645522023-11-06WarningsExact identifier
application number: M020
Image Skincare Prevention Plus Daily Ultimate ProtectionHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLC3473f94c-5faf-4415-9605-f58ec93cd2682023-11-06WarningsExact identifier
application number: M020
Image MD Restoring Lip Enhancer SPF15SUNSCREENSwiss-American CDMO, LLCe296579e-ba30-4a29-afe0-bb51f863369c2023-11-06WarningsExact identifier
application number: M020
Image Prevention Refiner Primer SPF50ZINC OXIDE, TITANIUM DIOXIDE SUNSCREENSwiss-American CDMO, LLC0e490f11-666c-420c-8c12-b45cd238ce472023-11-06WarningsExact identifier
application number: M020
Image Prevention Plus Professional Ultimate Protection Moisturizer SPF50HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE SUNSCREENSwiss-American CDMO, LLCd807f94a-f933-47d9-938f-b91f663af0782023-11-06WarningsExact identifier
application number: M020
Farmasi BB Beauty Balm Cream SPF 15- 01 LightTITANIUM DIOXIDEFarmasi US LLC97c1da03-b79c-46a3-a9f0-7aeb94ed66da2023-11-05WarningsExact identifier
application number: M020
Dr. C. Tuna Resurface Essential Day CreamHOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONEFarmasi US LLCb92ff1e9-9dc4-46cb-a99d-98ff15bffc792023-11-05WarningsExact identifier
application number: M020
Dr C Tuna Sun protector lip balm SPF 15HOMOSALATE, OCTINOXATEFarmasi US LLCddcd82b5-9ad2-2340-e053-2a95a90a4fc02023-11-05WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-653-60584110653601 TUBE in 1 CARTON (58411-653-60) / 21 mL in 1 TUBE1 tube2021-05-010000-00-00NoNoCurrent