KLENSKIN SPF LIP BALM BROAD SPECTRUM

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61369-301		I	Inactivated by FDA		2026-10-23
excluded package	package	61369-301	61369-301-23	I	Inactivated by FDA		2026-10-23

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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61369-301-23	KLENSKIN SPF LIP BALM BROAD SPECTRUMSPF-50 (ALL FLAVORS)	4.25 g in 1 TUBE	LIPSTICK	4.25		9

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61369-301	KLENSKIN SPF LIP BALM BROAD SPECTRUM SPF-50 (ALL FLAVORS) (AVOBENZONE, HOMOSALATE, OCTISALATE) LIPSTICK [COLABS INTL. CORP]	9	Legacy NDC, 1 package rows	20240116_118fd112-4085-4a76-bb64-46c57b3a6377.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61369-301-23	61369030123	4.25 g in 1 TUBE (61369-301-23)	4.25 g	2018-08-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
COLABS - KLENSKIN SPF LIP BALM BROAD SPECTRUM (61369-301)	CoLabs Intl. Corp	2024-01-15	HUMAN OTC DRUG LABEL	9