FDA.reportPublic FDA data

Kandesn CC Cream

Product NDC
62191-213
11-digit product format
621910213
Labeler code
62191
Product ID
62191-213_c81b3fc0-6b58-44f5-ad11-b71578d156e7
Type
HUMAN OTC DRUG
Nonproprietary name
Sunscreen Broad Spectrum SPF30
Dosage form
CREAM
Route
TOPICAL
Labeler
Sunrider Manufacturing L.P.
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2016-09-01
Marketing end
0000-00-00
Substance
TITANIUM DIOXIDE; ZINC OXIDE
Active strength
114 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62191-213DDiscontinued by firm2026-10-05
excluded packagepackage62191-21362191-213-01DDiscontinued by firm2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73df98bc-429f-4587-8299-6ad8d52a4f36Product name220250304
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
64b87b8d-6ae7-cef1-8fd2-34228b0cc1bcProduct name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62191-213KANDESN CC CREAM LIGHT MEDIUM (SUNSCREEN BROAD SPECTRUM SPF30) CREAM [SUNRIDER MANUFACTURING L.P.]3Legacy NDC20241223_9ccdccfe-c3ee-4e56-996f-6f7a1a8aa257.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62191-213-01621910213011 TUBE in 1 PACKAGE (62191-213-01) > 41.75 g in 1 TUBE1 tube2021-12-200000-00-00NoNoCurrent