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 288 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Open Nature Zinc Oxide Sunscreen Mineral Sunscreen SPF 30ZINC OXIDESafeway, Inc.dbeff8e8-250d-8274-e053-2995a90a984e2024-10-14WarningsExact identifier
application number: M020
Positive Light Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen 10NHOMOSALATE, ZINC OXIDERare Beauty, LLC2460281d-d433-0216-e063-6394a90a9d482024-10-13WarningsExact identifier
application number: M020
Walgreens 50 Coconut Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2436987c-2afe-06b5-e063-6394a90aceba2024-10-11WarningsExact identifier
application number: M020
Walgreens 50 Banana Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2436bd19-2299-6e89-e063-6394a90acd992024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 50 Clear Complexion Face SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf07238df-4970-7759-e053-2a95a90a39f92024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 70 Sport ContinuousAVOBENZONE, HOMOSALATE, OCTISALATE, OCTCRYLENEWALGREEN COMPANYe7165b39-54f9-4af6-e053-2a95a90af6642024-10-11WarningsExact identifier
application number: M020
WALGREENS SPF 100 SHEER BODY SUNSCREEN MISTAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf14bb3b4-1dce-06b9-e053-2995a90a8bc82024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 30 SportAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf12c9767-7cb7-12c8-e053-2995a90a17be2024-10-11WarningsExact identifier
application number: M020
Sulwhasoo UV Daily CreamAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE CREAMAmorepacific Corporatione00451d5-8433-c4e8-e053-2a95a90a62442024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 50 Sport Continuous SunscreenAVOBENZONE, HOMOSALAT, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf13ec3da-2dc2-04f7-e053-2995a90a198d2024-10-11WarningsExact identifier
application number: M020
Walgreens SPF 30 HydratingAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf4155692-16a7-11e8-e053-2995a90abd342024-10-11WarningsExact identifier
application number: M020
Walgreens Daily Facial Moisturizer with Broad Spectrum SPF 30 SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYf906792b-083e-13e2-e053-6294a90ab4cf2024-10-11WarningsExact identifier
application number: M020
Walgreens Daytime Facial Moisturizer with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEWALGREEN COMPANYf9c81d88-8e28-fa53-e053-6394a90ac5c42024-10-11WarningsExact identifier
application number: M020
WALGREENS 100 SHEER BROAD SPECTRUM SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYfa18067a-310b-bdc3-e053-6394a90aee792024-10-11WarningsExact identifier
application number: M020
Walgreens 50 Mineral Zinc Oxide SunscreenZINC OXIDEWALGREEN COMPANY24223fbf-8ce9-ec5e-e063-6294a90a29da2024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Mineral Zinc Oxide SunscreenZINC OXIDEWALGREEN COMPANY2422b327-ea83-f4c3-e063-6394a90a5c6e2024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Watermelon Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24256e54-ae34-91b2-e063-6394a90a33c02024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Premium Face Moisturizing SunscreenAVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24265a48-fd07-c78a-e063-6394a90ab67e2024-10-10WarningsExact identifier
application number: M020
Walgreens Broad Spectrum SPF 50 Body Oil SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2410df0a-db52-0769-e063-6394a90a52f32024-10-09WarningsExact identifier
application number: M020
Walgreens Broad Spectrum SPF 40 Radiant Facial SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24114416-33b9-c6ba-e063-6394a90a6f3b2024-10-09WarningsExact 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