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 224 of 353 · 7,049 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Obagi Skintrinsiq Firming ProtocolTITANIUM DIOXIDE AND ZINC OXIDEObagi Cosmeceuticals LLC67ba9f32-bbf4-4c14-9e97-08f1cb7d39962025-03-21WarningsExact identifier
application number: M020
Obagi Skintrinsiq Brightening ProtocolHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLC2f75ebf7-d6b6-45c6-ad5b-61739d260ff72025-03-21WarningsExact identifier
application number: M020
Hello Kitty Fun Broad Spectrum SPF 40ZINC OXIDEThe Creme Shop Inc30d37581-122c-ec92-e063-6294a90ab4252025-03-21WarningsExact identifier
application number: M020
Hello Kitty Sunny Days Broad Spectrum SPF 40ZINC OXIDEThe Creme Shop Inc30d3ed8c-f424-8d95-e063-6394a90a0cbc2025-03-21WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.c7142781-fa57-43e5-9436-cb29dd03a6692025-03-21WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTORAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION00ec7d9c-8550-45ce-8d0a-ef2caf84f98d2025-03-21WarningsExact identifier
application number: M020
Obagi Skintrinsiq Clarifiying ProtocolSALICYLIC ACID, TITANIUM DIOXIDE, AND ZINC OXIDEObagi Cosmeceuticals LLC08ba9ea8-73fd-472b-9cc4-67df167352ec2025-03-21WarningsExact identifier
application number: M020
Aveeno Kids Continuous Protection Sensitive Skin Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC3e51da46-6a81-4b74-b16e-3fc298a4ba592025-03-20WarningsExact identifier
application number: M020
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC2d2c58e2-0d15-4383-adae-12fc17b8ea502025-03-20WarningsExact identifier
application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50ZINC OXIDEKenvue Brands LLC1907126c-fd95-86e8-e063-6394a90a23ca2025-03-20WarningsExact identifier
application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 PlusZINC OXIDEKenvue Brands LLC4504a10d-6130-4ec5-823a-ab970709e6d72025-03-20WarningsExact identifier
application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50ZINC OXIDEEai-jr 286, Inc30caf1dd-142d-85d3-e063-6394a90a0c882025-03-20WarningsExact identifier
application number: M020
Sun Shades Lip Balm Cranberry TangerineAVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%Melaleuca Inc.f39606be-19c8-58d1-e053-2a95a90a908f2025-03-20WarningsExact identifier
application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCaa937596-2378-469f-a0e1-9700044e83b32025-03-20WarningsExact identifier
application number: M020
Obagi Medical Way to Glow KitHOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCf6f6e219-4ef6-be3b-e053-6294a90a660d2025-03-20WarningsExact identifier
application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)HOMOSALATE, OCTISALATE, AND ZINC OXIDEObagi Cosmeceuticals LLCe8d19915-8996-42df-a47b-2ce00d2bbe682025-03-20WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATION21bde283-a554-45c8-8733-2a8adeff41b12025-03-20WarningsExact identifier
application number: M020
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONESHISEIDO AMERICAS CORPORATION7a98171f-bf21-40d4-bc78-883aa0b0c4382025-03-20WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.5e2d7c94-d70a-47e4-9a4b-5953fe38ede22025-03-19WarningsExact identifier
application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15OCTINOXATE, OXYBENZONECarma Laboratories, Inc.50206f9e-2dd5-494f-9eed-f7d7ea6efda92025-03-18WarningsExact 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