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 318 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 16N fair-light neutralTITANIUM DIOXIDETarte, Inc.62fffef6-29ae-4137-b0b9-fb93d61679332023-12-21WarningsExact identifier
application number: M020
double duty beauty shape tape cloud coverage Broad Spectrum SPF 15 Sunscreen 12N fair neutralTITANIUM DIOXIDETarte, Inc.889860fc-7fce-47e9-af28-a3b2aec04a0e2023-12-21WarningsExact identifier
application number: M020
JLo Beauty That Big Screen Broad Spectrum SPF 30 MoisturizerHOMOSALATE, OCTISALATE, AND ZINC OXIDEAscendant Beauty LLCcba4e886-c4c6-4377-8f4c-250aef4b95fb2023-12-21WarningsExact identifier
application number: M020
COOLA Full Spectrum 360 Refreshing Water Cream SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLCd12e30bd-88ee-4e34-ae63-c34766aed3a82023-12-20WarningsExact identifier
application number: M020
COOLA Liplux Hydrating Oil SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC2d2ad94c-ea13-43c0-ab7f-acecf4d2309f2023-12-20WarningsExact identifier
application number: M020
Coola Bare Republic Mineral Face-Lotion SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%COOLA LLCa334a61d-5c5a-4f45-b202-6dd7bb3d250b2023-12-20WarningsExact identifier
application number: M020
Bare Republic Big Adventure Stick SPF 70TITANIUM DIOXIDE 3.5% ZINC OXIDE 16.9%COOLAe800f72f-8c8b-4a12-843f-1ee404055cf02023-12-20WarningsExact identifier
application number: M020
Coola Bare Republic Mineral Body Gel-Lotion SPF 30ZINC OXIDE 18.2%COOLA LLCd745d12e-8741-4bf2-89ec-c6f72a8d548b2023-12-20WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen SPF 70 - Peach BlossomAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECOOLA LLC6efa0d9f-0ff3-4b2f-9587-9630261bcbd12023-12-20WarningsExact identifier
application number: M020
sugar rush skin treat poreless tinted moisturizer Broad Spectrum SPF 20 Sunscreen lightTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.b49d5dc5-8d9b-49e4-8d07-d0d6af3fbbdc2023-12-20WarningsExact identifier
application number: M020
Coola Bare Republic Mineral Face Gel-Lotion SPF 30ZINC OXIDE 18.2%COOLA LLCad1614d4-5421-473d-a1e8-0ff18491df772023-12-20WarningsExact identifier
application number: M020
COOLA CLASSIC FACE SUNSCREEN White Tea Broad Spectrum SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC4e0e426d-f037-428f-98f2-2d3e945bd0402023-12-19WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Fragrance-Free SPF 50AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLC57f2fdeb-2abc-4ad3-bb89-5faee883c0e52023-12-19WarningsExact identifier
application number: M020
Baby Bare Republic Mineral Sunscreen SoftStick SPF 50ZINC OXIDECOOLA LLC1a603f62-86ec-4e66-a73f-718c5d0126762023-12-19WarningsExact identifier
application number: M020
COOLA Classic Body Sunscreen Pina Colada SPF 30AVOBENZONE HOMOSALATE OCTISALATE OCTOCRYLENEBentley Laboratories, LLCd508cef6-977f-4231-8c19-491569e999212023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint - HotZINC OXIDE 15%Bentley Laboratories, LLCa9e7a203-52f0-4a67-b3ea-65ff0968ec182023-12-19WarningsExact identifier
application number: M020
COOLA Refreshing Water Mist SPF 18AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBentley Laboratories, LLC658bf3fe-2246-40b6-8cb1-969bfdaffd1b2023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint Free - CoolZINC OXIDE 15%Bentley Laboratories, LLCcd80661f-348c-4bfd-a85c-041db1a1d0f42023-12-19WarningsExact identifier
application number: M020
Nudestix Daily Mineral Veil SPF 30 Tint - WarmZINC OXIDE 15%Bentley Laboratories, LLCd5fd3fea-5dcf-42ef-927a-3b4a3e1ccff82023-12-19WarningsExact identifier
application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutralTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.f5d54e9d-4963-419a-a091-bdbd1decd2b82023-12-19WarningsExact 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