FDA.reportPublic FDA data

cle de peau BEAUTE RADIANT FOUNDATION N M

Product NDC
58411-976
11-digit product format
584110976
Labeler code
58411
Product ID
58411-976_4ba8f2ec-8b92-1b13-e063-6394a90a9e57
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE and TITANIUM DIOXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
Shiseido Americas Corporation
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-02
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
1.06; .29 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 M
Brand name suffix
O30
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE1.06 g/21mL
TITANIUM DIOXIDE.29 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
3be1fe06-bd3b-4078-bee9-d3caf8d068ffAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-976-60cle de peau BEAUTE RADIANT FOUNDATION N MO301 in 1 BOXCREAM12
58411-976-60cle de peau BEAUTE RADIANT FOUNDATION N MO3021 mL in 1 TUBECREAM212

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 268 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Banana Boat simply protect sensitive MINERAL ENRICHED SUNSCREEN UVA/UVB BROAD SPECTRUM SPF 50HOMOSALATE,OCTISALATE,OCTOCRYLENE,ZINC OXIDEEdgewell Personal Care Brands, LLC92fdea59-c19d-627a-e053-2995a90aabdc2024-11-25WarningsExact identifier
application number: M020
VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15VITAMIN ENRICHED SKIN TINT BROAD SPECTRUM SPF 15Bobbi Brown Professional Cosmetics Inc.eecb05ab-2048-6e8d-e053-2995a90a82802024-11-22WarningsExact identifier
application number: M020
Covergirl Outlast Extreme Wear 3-in-1 Foundation 24 HR Full Coverage SPF 18 Octinoxate Sunscreen Liquid FoundationOCTINOXATENoxell Corporation258e8f05-295e-8e32-e063-6294a90a75482024-11-21WarningsExact identifier
application number: M020
MILKY MINERAL SUN SERUMTITANIUM DIOXIDE AND ZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity53834c89-b3b4-4e21-b9f6-19f95e78ba832024-11-21WarningsExact identifier
application number: M020
NATURAL MOISTURIZING FACE SUNSCREEN and PRIMERZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity5996f9b2-18c1-4c8f-a0ab-eca180db61ad2024-11-21WarningsExact identifier
application number: M020
NATURAL MINERAL BODY SUNSCREENZINC OXIDESynchronicity Spa, Inc. DBA Suntegritydc5116d4-3a42-44d4-b41a-e88b5b16d1112024-11-21WarningsExact identifier
application number: M020
IMPECCABLE SKIN - IVORYZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity98a7896e-4b03-4184-ac2e-6b49e47c0bc42024-11-21WarningsExact identifier
application number: M020
1177, 1178 Sunscreen1177, 1178 SUNSCREENDynarexc3142ddb-74ea-a7d1-e053-2a95a90a26f32024-11-20WarningsExact identifier
application number: M020
Covergirl Aquasmooth Broadspectrum SPF 20 All shadesTITANIUM DIOXIDENoxell Corporation952ea869-581e-4503-9f21-a77d061a417d2024-11-20WarningsExact identifier
application number: M020
Covergirl TruBlend Base Business Everyday Defense Primer SPF 20ENSULIZOLENOXELL CORPORATION8528aa01-fd4b-58a6-e053-2991aa0a3d6a2024-11-20WarningsExact identifier
application number: M020
Facial Skin Shield Broad Spectrum SPF50 PlusAVOBENZONE, ENSULIZOLE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEAHAVA - Dead Sea Laboratories Ltdbb62c700-be07-4fe3-b007-425a5f760b302024-11-20WarningsExact identifier
application number: M020
FOUNDATION LIGHT SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273ea785-241b-3e10-e063-6294a90a9fff2024-11-19WarningsExact identifier
application number: M020
FOUNDATION MEDIUM SPECTRUMOCTYL METHOXYCINNAMATE, ZINC OXIDE, TITANIUM DIOXIDEGuangzhou Bo win Trade Co., Ltd.273f4d65-b245-c27a-e063-6394a90ade072024-11-19WarningsExact identifier
application number: M020
Pool Bar London Not Just a Pretty Face Sunscreen SPF 50ZINC OXIDEPOOLBARc081acef-9e1d-4aa6-b49c-c92fe28af2c72024-11-19WarningsExact identifier
application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 30 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR3a481521-e209-4c86-895f-2e7392b7c5652024-11-19WarningsExact identifier
application number: M020
Pool Bar London I Scream For Sunscreen Hydrating Mineral Body Cream SPF 50 Coconut and Vanilla ScentedZINC OXIDEPOOLBAR1721023c-3321-4f0b-a053-6d0c657fa1b02024-11-19WarningsExact identifier
application number: M020
Theraderm Platinum Protection Facial Sunscreen SPF 40OCTOCRYLENE, OCTISALATE, ZINC OXIDETherapon Inc1fea6ad8-4d33-4f7c-800c-1bee644bd97f2024-11-19WarningsExact identifier
application number: M020
Fresh Monster Mineral SunscreenZINC OXIDEBlue Zebra Brands, Inc.230cc36d-5163-f423-e063-6394a90a81242024-11-19WarningsExact identifier
application number: M020
Covergirl Advanced Radiance Age Defying Makeup plus Sunscreen SPF 10 (All shades)OCTINOXATE AND TITANIUM DIOXIDENoxell356af30e-82c7-4e28-94bb-b536e74d01e12024-11-19WarningsExact identifier
application number: M020
Covergirl plus Olay Simply Ageless Foundation plus Titanium Dioxide Sunscreen Broad Spectrum SPF 28 (All shades)TITANIUM DIOXIDENoxell Corporationfab59bd6-4ef6-4626-9f75-edcd4088e6432024-11-19WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58411-976-60584110976601 TUBE in 1 BOX (58411-976-60) / 21 mL in 1 TUBE1 tube2024-12-02NoNoCurrent