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 290 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pure Protect Mineral Sunscreen Stick SPF50ZINC OXIDEKoco Life LLC22cd5999-9b9a-91a3-e063-6394a90a0da52024-09-23WarningsExact identifier
application number: M020
ABSOLUTELY natural Lip Balm Broad Spectrum SPF 15 SunscreenZINC OXIDEAbsolutely Naturaleb914dd8-9b11-44dd-8c4f-4d4c0c3bf1ea2024-09-23WarningsExact identifier
application number: M020
SUNSCREEN 01AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATECosmuses Cosmetics (Ningbo) Co., Ltd.229dabbc-9043-3c9d-e063-6394a90a56922024-09-21WarningsExact identifier
application number: M020
GLC OG Natural Tinted SPF 30 SunscreenZINC OXIDEGUD LIFE CO. LLC25e1e8ec-e19d-45f7-b339-5d12c2b511d62024-09-18WarningsExact identifier
application number: M020
Target Up and Up Sunscreen SPF 30 SPORT Broad SpectrumAVOBENZONE, HOMOSALATE,OCTISALATE,OCTOCRYLENETARGET CORPORATIONbad7d56e-662e-0776-e053-2a95a90a0af02024-09-18WarningsExact identifier
application number: M020
Target Up and Up Kids SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATIONb82b6d0d-616d-f041-e053-2995a90ae6a32024-09-18WarningsExact identifier
application number: M020
Note BB Advanced Skin Corrector SPF 15, 01OCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIef4ec3ae-809a-4608-96ca-4d8ad96380d82024-09-16WarningsExact identifier
application number: M020
Note BB Advanced Skin Corrector SPF 15, 02OCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI1e0ea43a-0c43-4994-a927-56ea6d721ccc2024-09-16WarningsExact identifier
application number: M020
Note BB 200 Soft IvoryOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI0a53f010-5cb4-43e3-88e8-0d9641bd131f2024-09-16WarningsExact identifier
application number: M020
Note BB 300 Light BeigeOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI92c7212a-1f85-4076-99c8-4db2a77ef69d2024-09-16WarningsExact identifier
application number: M020
Note BB 500OCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI0a02afa5-da58-4813-aab3-6d541e4fec202024-09-16WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 03 Medium BeigeOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIfeac1cc2-eb4c-43da-89fc-6c950202b00d2024-09-16WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 08 SunnyOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIa7cff735-ca8a-4a82-b4a7-41184cb423e62024-09-16WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 110 SmokeOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI0a9a30e7-4fcc-4518-bd83-a0126a459c9d2024-09-16WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 114 LatteOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI4d56721c-ffd0-4f27-81f3-e4e87f8a4d182024-09-16WarningsExact identifier
application number: M020
Note BB Concealer 01OCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI7ea1a3f4-4f99-4cb4-bbd5-1124289037312024-09-16WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 116 Golden BeigeOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIa5d26db8-257d-45b8-adda-498d81a1b7a22024-09-16WarningsExact identifier
application number: M020
Note Mattifying Extreme Wear Foundation 130 Cool RoseOCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIc52d92d9-e228-4840-aacc-ed97a61734432024-09-16WarningsExact identifier
application number: M020
Note BB Concealer 02OCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETId6d6d8d6-08a6-46fa-b808-cfaa29bfbe092024-09-16WarningsExact identifier
application number: M020
Note BB Concealer 03OCTINOXATEALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETIa6f71b08-d737-439e-9e79-e93975d457ca2024-09-16WarningsExact 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