FDA.reportPublic FDA data

cle de peau BEAUTE RADIANT FOUNDATION N

Product NDC
58411-643
11-digit product format
584110643
Labeler code
58411
Product ID
58411-643_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
O60
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
58411-643-60cle de peau BEAUTE RADIANT FOUNDATION NO6021 mL in 1 TUBEEMULSION213
58411-643-60cle de peau BEAUTE RADIANT FOUNDATION NO601 in 1 CARTONEMULSION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-643CLE 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 295 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lancome Paris Renergie HPN 300 Peptide Broad Spectrum SPF 25 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIE01c9c677-9da1-47d9-8b7e-b21f8450c5c32024-06-26WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Lifting Firming Dark Spot Correcting Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc5ab9c228-28e2-43fc-8e0b-7f8e118cb3882024-06-26WarningsExact identifier
application number: M020
SEAWEED BATH CO SPF 40 SPORTAVOBENZONE, OCTISALATE, OCTOCRYLENEThe Seaweed Bath Co.d64d4a52-0bea-4bbc-8d34-e16c1b4efe8c2024-06-26WarningsExact identifier
application number: M020
SEAWEED BATH CO Everyday Mineral SPF 40ZINC OXIDEThe Seaweed Bath Co.8380bb3f-47d0-4675-b326-620ffb74dbdf2024-06-26WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Incbe2a83fb-e4f8-4313-b5bd-150f351fb3452024-06-26WarningsExact identifier
application number: M020
Lancome Paris Renergie HPN 300 Peptide Broad Spectrum SPF 25 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc60689efb-2dd4-4322-a621-54eb2c3c3dc22024-06-26WarningsExact identifier
application number: M020
Lancome Paris Renergie Lift MultiAction Ultra Lifting Firming Dark Spot Correcting Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE AND OCTOCRYLENESICOS ET CIEd8449209-65d0-43c6-8750-0f460a9501572024-06-26WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Reno Broad Spectrum SPF 25 SunscreenOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE066a0951-2e7e-40c0-8035-4d708a32f16c2024-06-26WarningsExact identifier
application number: M020
GUIDANCE TO GLOW TRU SPF 35ZINC OXIDEGUIDANCE TO GLOW SKIN CARE21b4747b-b173-43c9-b0d4-1dbba5775ff82024-06-25WarningsExact identifier
application number: M020
Proceuticals Private Label by TiZO non-tinted mineral sunscreen 20% zinc oxideZINC OXIDEFallien Cosmeceuticals, Ltd1bbd14ec-4240-f0c2-e063-6394a90a2c072024-06-25WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin EAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENEL'Oreal USA Products Inc0200a00f-2b57-454d-933d-a7d48644be6e2024-06-25WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Care and Glow Skincare Foundation Broad Spectrum SPF 27 SunscreenENSULIZOLEL'Oreal USA Products Inc8e48e675-0b4f-4b91-85de-c4e29be651472024-06-25WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENESICOS ET CIE427a21cc-a668-4af8-94cb-b981d5c1919f2024-06-25WarningsExact identifier
application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer with Antioxidant Vitamin EAVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENESICOS ET CIE451e50a2-2dd7-4c90-88c9-b9f9056d7ee32024-06-25WarningsExact identifier
application number: M020
Lancome Paris Teint Idole Ultra Care and Glow Skincare Foundation Broad Spectrum SPF 27 SunscreenENSULIZOLESICOS ET CIE979db22b-97eb-4818-aa01-1288b56e38b52024-06-25WarningsExact identifier
application number: M020
Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water ResistantZINC OXIDESQWEEN LLCb5bf1c4c-7c48-423c-b4fc-52ae57f339fd2024-06-24WarningsExact identifier
application number: M020
BANANA BOATZINC OXIDEEdgewell Personal Care Brands LLC1ba50f16-4b76-825f-e063-6294a90a2a4d2024-06-24WarningsExact identifier
application number: M020
BANANA BOATZINC OXIDEEdgewell Personal Care Brands LLC1ba57692-c36d-ef4a-e063-6394a90a12362024-06-24WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE66a91768-6012-485a-b569-a293ea6d48802024-06-24WarningsExact identifier
application number: M020
Yves Saint Laurent All Hours Foundation Broad Spectrum SPF 30 Sunscreen Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc43539766-2e70-4b42-b64b-1d30367b2eb92024-06-24WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-643-60584110643601 TUBE in 1 CARTON (58411-643-60) / 21 mL in 1 TUBE1 tube2021-05-010000-00-00NoNoCurrent