FDA.reportPublic FDA data

cle de peau BEAUTE THE FOUNDATION N

Product NDC
58411-842
11-digit product format
584110842
Labeler code
58411
Product ID
58411-842_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

Additional Listing Data#

Finished product
Yes
Brand name base
cle de peau BEAUTE THE FOUNDATION N
Brand name suffix
O20 LIGHT MEDIUM OCHER
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii15FIX9V2JP, 4Y5P7MUD51

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
58411-842-50cle de peau BEAUTE THE FOUNDATION NO20 LIGHT MEDIUM OCHER1 in 1 BOXEMULSION13
58411-842-50cle de peau BEAUTE THE FOUNDATION NO20 LIGHT MEDIUM OCHER28 mL in 1 BOTTLE, GLASSEMULSION283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-842CLE 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58411-842-50584110842501 BOTTLE, GLASS in 1 BOX (58411-842-50) / 28 mL in 1 BOTTLE, GLASS2022-04-010000-00-00NoNoCurrent