KLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUM

Product NDC
61369-202
11-digit product format
613690202
Labeler code
61369
Product ID
61369-202_d8286f7c-e227-13a2-e053-2995a90aa82a
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, ZINC
Dosage form
GEL
Route
TOPICAL
Labeler
CoLabs Intl. Corp
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-11-24
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTISALATE; ZINC OXIDE
Active strength
10 g/100mL; g/100mL; g/100mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61369-202IInactivated by FDA2026-10-05
excluded packagepackage61369-20261369-202-13IInactivated by FDA2026-10-05

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
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61369-202-13KLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUMSPF 3088 mL in 1 TUBEGEL884

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61369-202KLENSKIN SUNSCREEN FACE AND BODY BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, ZINC) GEL [COLABS INTL. CORP]4Legacy NDC, 1 package rows20240116_0c5d339c-6e7c-4287-b261-a0f5f8fdd06d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61369-202-136136902021388 mL in 1 TUBE (61369-202-13) 88 ml2020-11-240000-00-00NoNoCurrent