KLENSKIN WASH ON SUNSCREEN

Product NDC
61369-106
Requested package NDC
61369-106-18
11-digit product format
613690106
Labeler code
61369
Product ID
61369-106_d8288751-f327-1dc0-e053-2995a90a139f
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, OCTOCRYLENE
Dosage form
GEL
Route
TOPICAL
Labeler
CoLabs Intl. Corp
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-08-05
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength
3 g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage61369-10661369-106-18IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61369-106-18KLENSKIN WASH ON SUNSCREENSPF-30236 mL in 1 BOTTLEGEL2367

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61369-106KLENSKIN WASH ON SUNSCREEN SPF-30 (AVOBENZONE, OCTINOXATE, OCTOCRYLENE) GEL [COLABS INTL. CORP]7Legacy NDC, 1 package rows20240116_b3f01646-d3d8-446d-993d-526287fb8b44.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61369-106-1861369010618236 mL in 1 BOTTLE (61369-106-18) 236 ml2020-08-050000-00-00NoNoCurrent