FDA.reportPublic FDA data

cle de peau BEAUTE RADIANT FLUID FOUNDATION

Product NDC
58411-554
11-digit product format
584110554
Labeler code
58411
Product ID
58411-554_47abf53a-ec68-9625-e063-6394a90a797e
Type
HUMAN OTC DRUG
Nonproprietary name
TITANIUM DIOXIDE
Dosage form
EMULSION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-07-01
Substance
TITANIUM DIOXIDE
Active strength
2.72118 g/35mL
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 FLUID FOUNDATION
Brand name suffix
B60
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TITANIUM DIOXIDE2.72118 g/35mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
b2b55a7a-1f68-429d-ba70-5bb6c7e0d8d3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58411-554-102024-02-06C16284748780-11030e365-440a-111a-e063-dadaa90a10e2clé de peau BEAUTÉ RADIANT FLUID FOUNDATION
58411-554-102024-01-30C16284748780-11030e365-440a-111a-e063-dadaa90a10e2clé de peau BEAUTÉ RADIANT FLUID FOUNDATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-554-10cle de peau BEAUTE RADIANT FLUID FOUNDATION B601 in 1 CARTONEMULSION16
58411-554-10cle de peau BEAUTE RADIANT FLUID FOUNDATION B6035 mL in 1 BOTTLEEMULSION356

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-554CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF10 (TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION I10 (TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O10 (TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION O20 (TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE .......OXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B100 (TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF50 (TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION BF60 (TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE RADIANT FLUID FOUNDATION B90 (TITANIUM DIOXIDE) EMULSION [SHISEIDO AMERICAS CORPORATION]4Current NDC, Legacy NDC, 2 package rows20240207_b2b55a7a-1f68-429d-ba70-5bb6c7e0d8d3.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 57 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bath and Body Works SPF At The BeachAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.1c315bdb-dc33-1737-e063-6294a90a31a42026-03-02WarningsExact identifier
application number: M020
Bath and Body Works SPF Tahiti IsleAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEBath & Body Works, Inc.38d02c8d-cdc8-b8d6-e063-6294a90ad9e42026-03-02WarningsExact identifier
application number: M020
SportAVOBENZONE, HOMOSALATE, OCTISALATE, OCTISALATEOld East Main Co.a460e512-f268-4941-beb6-29df10fdbb3a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Tanning Sunscreen SPF 15AVOBENZONE HOMOSALATE OCTISALATEOld East Main Co.42258ebe-e3cc-4d70-e063-6294a90a96512026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALAT, OCTOCRYLENEOld East Main Co.db876d34-1af9-4e0a-9e9a-32a8b00e94052026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE,OTISALATE, OCTOCRYLENEOld East Main Co.2ea288fe-815d-4568-9592-55ea428448fa2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.cea1c223-c9d4-42ac-8c5b-c0ca647d57a12026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
sunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOld East Main Co.00ee1dc6-b4f3-4ae3-890c-8e37f6d3fe3a2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.8f4a6a31-2fae-42fe-924f-10237c59e7912026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ef48288b-533f-4924-ba12-fc8cb83643d42026-03-02WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.e6976bf4-ad77-4953-858f-4a0ec7f4300c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.b3d2da09-d9c9-4c27-82fe-a434ece2f0992026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ba9331ef-3744-4072-80a2-af95c6f7ee052026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf2026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.1a53d8d5-e650-4825-8a3b-7cf42c36e3e52026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.086dfda5-9fe7-46b4-9964-4977b86cfdd52026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATEOld East Main Co.ce9a2139-c5c2-43e2-bd51-1f14ace594d92026-03-02Warnings, Adverse reactionsExact identifier
application number: M020
Bask SPF 40 Broad SpectrumAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESurfside Skincare, Inc. dba Bask Suncare49a30877-e39f-46a3-e063-6394a90a8dd22026-03-02WarningsExact identifier
application number: M020
Sunscreen SPF30AVOBENZONE 3% HOMOSALATE 10% OCTOCRYLENE 5%Worthy Promotional Productsf6014a97-12d3-4f42-86de-866a206c6c062026-03-02WarningsExact identifier
application number: M020
2000DL-CL30VSPF30 BS VANILLAEpic Laboratories, LLC02488aad-28be-4ffb-e063-6294a90ad01e2026-03-02WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-554-10584110554101 BOTTLE in 1 CARTON (58411-554-10) / 35 mL in 1 BOTTLE1 bottle2020-07-010000-00-00NoNoCurrent