FDA.reportPublic FDA data

cle de peau BEAUTE RADIANT FLUID FOUNDATION

Product NDC
58411-548
11-digit product format
584110548
Labeler code
58411
Product ID
58411-548_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
O100
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
58411-548-102024-02-06C16284748780-11030e365-440a-111a-e063-dadaa90a10e2clé de peau BEAUTÉ RADIANT FLUID FOUNDATION
58411-548-102024-01-30C16284748780-11030e365-440a-111a-e063-dadaa90a10e2clé de peau BEAUTÉ RADIANT FLUID FOUNDATION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-548-10cle de peau BEAUTE RADIANT FLUID FOUNDATION O1001 in 1 CARTONEMULSION16
58411-548-10cle de peau BEAUTE RADIANT FLUID FOUNDATION O10035 mL in 1 BOTTLEEMULSION356

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-548CLE 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 213 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS351251f5-e656-98b6-e063-6394a90ad8052025-05-14WarningsExact identifier
application number: M020
No7 Future Renew Damage Reversal Day Cream Sunscreen Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENEBCM Cosmetique SAS35129e6f-c6bd-a9f7-e063-6394a90ab0e42025-05-14WarningsExact identifier
application number: M020
Noevir Raysela UV Shield PrimerZINC OXIDE, OCTINOXATENippon Shikizai, Inc.45030b2f-21cf-4285-af12-87ea8f0b8df72025-05-14WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEONESKIN INC.351d55f6-fcd9-1d47-e063-6294a90a2cf02025-05-14WarningsExact identifier
application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350cd329-8fe2-314f-e063-6394a90ac9542025-05-13WarningsExact identifier
application number: M020
Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30ZINC OXIDELancer Skincare LLC522a9158-2fd1-4634-adef-2ba84c86bcd72025-05-13WarningsExact identifier
application number: M020
BANANA BOATAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENENavajo Manufacturing Company Inc.33f13aa4-9279-c251-e063-6294a90a2d672025-05-12WarningsExact identifier
application number: M020
OS-01 FACE SPF BS SPF 30 TINTED DEEPZINC OXIDEAllure Labs34f51ff4-541d-2b2e-e063-6394a90a39da2025-05-12WarningsExact identifier
application number: M020
Bright Guard Natural SPF 30ZINC OXIDERenu Laboratories, LLCe7035fcd-6894-3360-e053-2a95a90a6f1d2025-05-12WarningsExact identifier
application number: M020
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEAllure Labs34f674c1-5d59-915a-e063-6394a90a6c2f2025-05-12WarningsExact identifier
application number: M020
Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONEMeaningful Beauty, LLCf59fe019-569b-49ba-accf-fa4d356ce96b2025-05-12WarningsExact identifier
application number: M020
Cicatricure Gold Lift SPF 30 SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEGenomma Lab USA34cc5b3c-af36-e202-e063-6294a90a13a72025-05-10WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
application number: M020
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
application number: M020
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
application number: M020
cle de peau BEAUTE UV PROTECTIVE NAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEShiseido Americas Corporationfe19a057-a3c6-4c53-92f9-a4a960cd5b082025-05-07WarningsExact identifier
application number: M020
Winter Survival KitOCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONEDuke Cannon Supply Co.2487ab56-7856-66b0-e063-6394a90a9d872025-05-07WarningsExact identifier
application number: M020
OS-01 Lip SPF BS SPF15ZINC OXIDEAllure Labs3490ed60-60b9-dfcd-e063-6394a90ab17a2025-05-07WarningsExact identifier
application number: M020
Lip Love Moisture Balm SPF30 - Nude BeigeZINC OXIDEKoco Life LLC3491084b-348a-f2bf-e063-6394a90abd252025-05-07WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-548-10584110548101 BOTTLE in 1 CARTON (58411-548-10) / 35 mL in 1 BOTTLE1 bottle2020-07-010000-00-00NoNoCurrent