FDA.reportPublic FDA data

cle de peau BEAUTE THE FOUNDATION N

Product NDC
58411-841
11-digit product format
584110841
Labeler code
58411
Product ID
58411-841_47a7a294-559d-8d19-e063-6394a90a5440
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
2022-04-01
Substance
OCTINOXATE; TITANIUM DIOXIDE
Active strength
1092; 924 mg/28mL; mg/28mL
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 THE FOUNDATION N
Brand name suffix
O10 LIGHT OCHER
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE1092 mg/28mL
TITANIUM DIOXIDE924 mg/28mL

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
beefe840-6f32-483b-8a37-2696adb8eea1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-841-50cle de peau BEAUTE THE FOUNDATION NO10 LIGHT OCHER1 in 1 BOXEMULSION13
58411-841-50cle de peau BEAUTE THE FOUNDATION NO10 LIGHT OCHER28 mL in 1 BOTTLE, GLASSEMULSION283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-841CLE DE PEAU BEAUTE THE FOUNDATION N O50 TAN OCHER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE THE FOUNDATION N I10 VERY LIGHT IVORY (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE THE FOUNDATION N O10 LIGHT OCHER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE THE FOUNDATION N O20 LIGHT MEDIUM OCHER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE THE FOUNDATION N O30 MEDIUM OCHER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE THE FOUNDATION N O40 LIGHT TAN OCHER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE THE FOUNDATION N O60 DEEP TAN OCHER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE THE FOUNDATION N O80 DEEP OCHER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE THE FOUNDATION N O100 RICH DEEP OCHER (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE THE FOUNDATION N B10 LIGHT BEIGE (OCTINOXATE AND TITANIUM DIOXIDE) EMULSION CLE DE PEAU BEAUTE THE FOUNDATION N B20 LIGHT MEDIUM2Current NDC, Legacy NDC, 2 package rows20241225_beefe840-6f32-483b-8a37-2696adb8eea1.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 99 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DR.JART EVERY SUN DAY MINERAL SUN SCREENTITANIUM DIOXIDE, ZINC OXIDEHave & Be Co., Ltd.f06c31b4-da5f-6495-e053-2995a90ae67c2025-12-31WarningsExact identifier
application number: M020
ALMOST powder MAKEUP BROAD SPECTRUM SPF 18OCTINOXATE AND TITANIUM DIOXIDECLINIQUE LABORATORIES LLC402add6d-a81e-4c9e-aee1-4abeb480894f2025-12-31WarningsExact identifier
application number: M020
RED GECKO BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEFormula 7venz L.L.C.e8e350e7-9225-4802-89a6-66e45ebc442d2025-12-31WarningsExact identifier
application number: M020
Kinfield Daily Dew Sea Kelp Moisturizer Sunscreen Broad Spectrum SPF 35KINFIELD DAILY DEW SEA KELP MOISTURIZER SUNSCREEN LOTION BROAD SPECTRUM SPF 35Kinfield, Inc.0710db9f-fe91-4b98-a337-5fde33d98a9d2025-12-30WarningsExact identifier
application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.1030c5a4-3067-48e6-a21c-0d327ef434d02025-12-30WarningsExact identifier
application number: M020
Kinfield Cloud Cover Mineral Body Sunscreen Broad Spectrum SPF 35KINFIELD CLOUD COVER MINERAL BODY SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.612c5730-c3b4-486e-8ce9-8a861f676fa82025-12-30WarningsExact identifier
application number: M020
Kinfield Liplock SPF 15 Lip Balm Broad Spectrum SunscreenKINFIELD LIPLOCK SUNSCREENKinfield, Inc.477aa1a2-c893-4750-84da-e5afe7ccd45b2025-12-30WarningsExact identifier
application number: M020
Kinfield Sunglow Luminizing Facial Sunscreen Broad Spectrum SPF 35KINFIELD SUNGLOW LUMINIZING FACIAL SUNSCREEN BROAD SPECTRUM SPF 35Kinfield, Inc.cbdfd0ae-514b-4b53-98ad-4270163bd0df2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - FairOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC472f4f34-99bc-2ff6-e063-6294a90a33c92025-12-30WarningsExact identifier
application number: M020
EVEN BETTER CLINICAL VITAMIN MAKEUP BROAD SPECTRUM SPF 45ENSULIZOLE, OCTINOXATE, OCTISALATE, AND ZINC OXIDECLINIQUE LABORATORIES LLC2397aca5-bf0a-619d-e063-6394a90a7ab92025-12-30WarningsExact identifier
application number: M020
Resource Essentials Sun Protection Mineral SPF 3014% ZINC OXIDESkinresource.md, L.L.C.45b486cf-28ee-6392-e063-6394a90affb02025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47313277-8884-70b5-e063-6394a90a5fca2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - MediumOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47320858-0aea-6ee9-e063-6294a90a9fa92025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Light WarmOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47325530-b097-db9a-e063-6294a90a335d2025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - TanOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47328eb4-8ad7-28b5-e063-6294a90a20b12025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - Tan DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4732bbec-d9f9-1639-e063-6394a90aff822025-12-30WarningsExact identifier
application number: M020
Perfect Glow BB Cream Sunscreen SPF 30 - DeepOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4732ecd0-5261-7f11-e063-6394a90a26f32025-12-30WarningsExact identifier
application number: M020
ScalpProtectionSpraySCALP PROTECTION SPRAYNaturich Labsc227ff3a-bbbb-5cc5-e053-2a95a90a8e322025-12-30WarningsExact identifier
application number: M020
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC0918fdd3-cffb-78e9-e063-6394a90ad5c72025-12-30WarningsExact identifier
application number: M020
SLMDAVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONESkin PS Brands1aa36c01-21b5-f06e-e063-6294a90a608f2025-12-30WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58411-841-50584110841501 BOTTLE, GLASS in 1 BOX (58411-841-50) / 28 mL in 1 BOTTLE, GLASS2022-04-010000-00-00NoNoCurrent