Eleven Perfect Form Tinted Lip Balm

Product NDC: 71644-014
11-digit product format: 716440014
Labeler code: 71644
Product ID: 71644-014_f1ffea2c-8134-e451-e053-2a95a90a27dc
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Cyberderm Laboratories inc.
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2020-06-18
Marketing end: 0000-00-00
Substance: ZINC OXIDE
Active strength: 20 g/100mL
Pharmacologic classes: Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
NDC exclude flag: No
Listing certified through: 2024-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71644-014		D	Discontinued by firm		2026-10-05
excluded package	package	71644-014	71644-014-10	D	Discontinued by firm		2026-10-05

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

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71644-014-10	2023-11-27	C162847	48780-1	0191ceaa-612a-198a-e063-dbdaa90aec3e	Eleven Tinted Lip Balm Power Player
71644-014-10	2023-07-28	C162847	48780-1	0191ceaa-612a-198a-e063-dbdaa90aec3e	Eleven Tinted Lip Balm Power Player

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71644-014	ELEVEN PERFECT FORM TINTED LIP BALM POWER PLAYER (ZINC OXIDE) CREAM [CYBERDERM LABORATORIES INC.]	4	Legacy NDC	20231128_a89f021e-1a82-83f7-e053-2a95a90a518f.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71644-014-10	71644001410	1 TUBE in 1 CARTON (71644-014-10) > 10 mL in 1 TUBE	1 tube	2020-06-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eleven Tinted Lip Balm Power Player	Cyberderm Laboratories inc. \| Inspec Solutions	2025-12-10	HUMAN OTC DRUG LABEL	5