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 320 of 352 · 7,030 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30TITANIUM DIOXIDERodan & Fields1a936053-2be0-4c52-a073-ba846b87f8112023-12-12WarningsExact identifier
application number: M020
Beet the sun lightweight sunscreen broad spectrum spf 40 paAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKrave Beauty, LLCff93d086-ec80-6bd5-e053-6294a90af0192023-12-12WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Up The AntiTITANIUM DIOXIDE, ZINC OXIDEBiopelle, Inc.37506766-370e-4ae4-8dbe-915a763e7c552023-12-12WarningsExact identifier
application number: M020
INTELLIGENT BEAUTY LABS Age Defying Day Broad Spectrum SPF 20AVOBENZONE, OCTINOXATE, OCTISALATEDermStore, LLC19640e0c-c6b3-43b8-91e9-d8d9fff2e44e2023-12-12WarningsExact identifier
application number: M020
Dr. Perrys Day Thyme SPF 20 Broad Spectrum SunscreenZINC OXIDEEnglewood Lab, Inc.273d8e30-a6bc-4b26-919c-9332fd5197fa2023-12-12WarningsExact identifier
application number: M020
Youth Activating BB SPF30 Shade 3ZINC OXIDE, TITANIUM DIOXIDEEnglewood Lab, Inc.c84207c4-a779-4c00-a486-86eaf8ece1692023-12-12WarningsExact identifier
application number: M020
Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fieldsc7526b69-d059-499a-9134-3a1f5d0471b32023-12-12WarningsExact identifier
application number: M020
SERIOUS SKINCARE SERIOUS C3 PLASMA BIO TECHNOLOGY C VITAMIN C ESTER PROTECTIVE DAYTIME BROAD SPECTRUM MOISTURIZER SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited4d11cc46-3942-1561-e054-00144ff8d46c2023-12-12WarningsExact identifier
application number: M020
ACTIVE ARGAN 365 SPF 30 BROAD SPECTRUM ACTIVATED ARGAN COMPLEXZINC OXIDESIBORG LLC9c4897f8-8fcb-4a0f-b42e-f582e2934f022023-12-12WarningsExact identifier
application number: M020
Byoma Moisturizing Gel Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATEENGLEWOOD LAB, INC.f63fe60f-9863-1dfb-e053-2a95a90a90a52023-12-12WarningsExact identifier
application number: M020
MD Mineral BB Creme Broad Spectrum SPF 50 Water Resistant 80 MinTITANIUM DIOXIDE, ZINC OXIDEENGLEWOOD LAB, INC.5742da4b-6713-4de9-8ab8-b2bf2983371a2023-12-12WarningsExact identifier
application number: M020
restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea ComplexZINC OXIDERESTORSEA INC80ed7b28-16e0-4c9a-8e36-9d32ca3ddb9a2023-12-12WarningsExact identifier
application number: M020
ReVive Fermitif Neck Renewal SPF 15AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONEGurwitch Products, LLCde54d4ff-f9b4-4a12-95ea-fc2b61bee1c32023-12-12Exact identifier
application number: M020
Laura Mercier Flawless Skin Daily Face Shield SPF 40OCTINOXATE, TITANIUM DIOXIDEGurwitch Products, LLCf86729cd-682f-47b2-9bfa-1113721bfec02023-12-12WarningsExact identifier
application number: M020
Boscia BB SPF 27 PATITANIUM DIOXIDEBoscia LLC5dc86c0b-c340-4643-a174-a6b4c0826ca92023-12-12WarningsExact identifier
application number: M020
Dr.Denese SPF 30 Defense DayZINC OXIDE, OCTINOXATESkinScience Labs, Inc511dd97b-0f83-4ce9-8bfd-fa385f0dc8aa2023-12-12WarningsExact identifier
application number: M020
Boscia Daily Hydration SPF 15 Broad Spectrum For Normal To Oily SkinAVOBENZONE, OCTINOXATEBoscia LLC0c987cb9-7049-44b9-9935-647b0411a7342023-12-12WarningsExact identifier
application number: M020
Boscia BB Broad Spectrum SPF 27 PA Self Adjusting ShadeTITANIUM DIOXIDE, ZINC OXIDEBoscia LLC82a23aab-404f-46bb-afaa-8ba9b9bdbefd2023-12-12WarningsExact identifier
application number: M020
Boscia Restorative Day Moisture Broad Spectrum SPF 15 For Dry SkinAVOBENZONE, OCTINOXATEBoscia LLC657b04c6-d15b-470b-92e6-e59ed7e8b1162023-12-12WarningsExact identifier
application number: M020
Cellular Laboratories De-Aging Sunscreen Broad Spectrum SPF 50 PlusHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENEMarket Americac1898e00-05f1-4e28-9fa8-8cda1b1785952023-12-12WarningsExact 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