LipCoTZ

Product NDC: 58892-125
11-digit product format: 588920125
Labeler code: 58892
Product ID: 58892-125_5d4a9076-4a63-4ea3-8776-802e06fba806
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: LIPSTICK
Route: TOPICAL
Labeler: Fallien Cosmeceuticals, LTD.
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2005-04-01
Marketing end: 0000-00-00
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 40 mg/g; mg/g
NDC exclude flag: E
Listing certified through: 2017-12-31
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	58892-125		I	Inactivated by FDA		2026-10-05
excluded package	package	58892-125	58892-125-87	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	58892-125-87	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	58892-125-87	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	58892-125-87	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	58892-125-87	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	58892-125-87	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	58892-125-87	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58892-125-87	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58892-125-87	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58892-125-87	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	58892-125-87	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	58892-125-87	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	58892-125-87	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	58892-125-87	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	58892-125-87	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	58892-125-87	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	58892-125-87	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	58892-125-87	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	58892-125-87	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	58892-125-87	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	58892-125-87	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	58892-125-87	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	58892-125-87	`110d247fa046…`	`a55b01930146…`

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 concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58892-125-87	2019-10-21	C162847	48780-1	956f9ecf-d188-621f-e053-dbdaa90a74ad	LIPCŌTZ

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58892-125-87	LipCoTZ Lip Balm/Sunscreen	1 in 1 CARTON	LIPSTICK	1		1
58892-125-87	LipCoTZ Lip Balm/Sunscreen	4.5 g in 1 TUBE	LIPSTICK	4.5		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Titanium Dioxide	ACTIVE INGREDIENT	15FIX9V2JP	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Titanium Dioxide	ACTIVE MOIETY	15FIX9V2JP	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
.ALPHA.-Tocopherol Acetate, D-	INACTIVE INGREDIENT	A7E6112E4N	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Alpha-Tocopherol	INACTIVE INGREDIENT	H4N855PNZ1	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Aluminum Hydroxide	INACTIVE INGREDIENT	5QB0T2IUN0	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Aluminum Oxide	INACTIVE INGREDIENT	LMI26O6933	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Aluminum Stearate	INACTIVE INGREDIENT	U6XF9NP8HM	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Ascorbic Acid	INACTIVE INGREDIENT	PQ6CK8PD0R	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Ascorbyl Palmitate	INACTIVE INGREDIENT	QN83US2B0N	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
C12-15 Alkyl Benzoate	INACTIVE INGREDIENT	A9EJ3J61HQ	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Ceresin	INACTIVE INGREDIENT	Q1LS2UJO3A	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Cetearyl Isononanoate	INACTIVE INGREDIENT	P5O01U99NI	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Ethylhexyl Palmitate	INACTIVE INGREDIENT	2865993309	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Ginger Oil	INACTIVE INGREDIENT	SAS9Z1SVUK	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Hexyldecanol	INACTIVE INGREDIENT	151Z7P1317	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Hexyldecyl Laurate	INACTIVE INGREDIENT	0V595C1P6M	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Kiwi Fruit	INACTIVE INGREDIENT	71ES77LGJC	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Lecithin, Soybean	INACTIVE INGREDIENT	1DI56QDM62	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Lime (Citrus)	INACTIVE INGREDIENT	8CZS546954	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Polyethylene Glycol 400	INACTIVE INGREDIENT	B697894SGQ	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Propylene Glycol Dicaprylate/Dicaprate	INACTIVE INGREDIENT	O4446S9CRA	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Stearic Acid	INACTIVE INGREDIENT	4ELV7Z65AP	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1
Sunflower Oil	INACTIVE INGREDIENT	3W1JG795YI	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-125	LIPCOTZ (TITANIUM DIOXIDE, ZINC OXIDE) LIPSTICK [FALLIEN COSMECEUTICALS, LTD.]	1	Legacy NDC, 2 package rows	20100915_0d0bd849-3f96-4d7a-9ca9-7cf93f4e001b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
58892-125-87	58892012587	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
LIPCŌTZ	Fallien Cosmeceuticals, LTD. \| Process Technologies & Packaging \| Custom Analytics LLC	2010-09-09	HUMAN OTC DRUG LABEL	1