TiZO Tinted Lip Protection SPF 45

Product NDC: 58892-339
11-digit product format: 588920339
Labeler code: 58892
Product ID: 58892-339_669e250a-f426-4dde-9e3a-b2b2cf86c911
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: STICK
Route: TOPICAL
Labeler: Fallien Cosmeceuticals, LTD
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-10-01
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 40; 55 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	58892-339		U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58892-339	58892-339-45	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: TiZO Tinted Lip Protection SPF 45
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	40 mg/g
ZINC OXIDE	55 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58892-339-45	TiZO Tinted Lip Protection SPF 45	1 in 1 CARTON	STICK	1		3
58892-339-45	TiZO Tinted Lip Protection SPF 45	4.5 g in 1 TUBE	STICK	4.5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-339	TIZO TINTED LIP PROTECTION SPF 45 (TITANIUM DIOXIDE, ZINC OXIDE) STICK [FALLIEN COSMECEUTICALS, LTD]	3	Current NDC, Legacy NDC, 2 package rows	20250112_81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 177 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e9b0642-53ed-ec94-e063-6394a90aec3d	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0d977158-8b5d-66ac-e063-6294a90a4d5c	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-Sun Kit SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0eae4b71-60be-9715-e063-6294a90af463	2025-10-20	Warnings	Exact identifier application number: M020
Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen	ZINC OXIDE	Attitude DBA 9055-7588 Qubec Inc.	9ed70230-980c-474c-9f72-a6be0f355124	2025-10-20	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE OCTISALATE OCTOCRYLENE	Edgewell Personal Care Brands LLC	419b8043-7921-ca77-e063-6394a90a99ba	2025-10-20	Warnings	Exact identifier application number: M020
Illuminizing Blendrops Broad Spectrum SPF 46	HOMOSALATE, OCTISALATE, ZINC OXIDE	Wasatch Product Development, LLC	419c8718-6b9e-3df7-e063-6294a90a1e3b	2025-10-20	Warnings	Exact identifier application number: M020
Sonni SunDay Serum	ZINC OXIDE	Sonni	419d4ada-fe9b-b774-e063-6394a90a3d09	2025-10-20	Warnings	Exact identifier application number: M020
Lip Clear Lysine Plus Coldstick	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	66f84e56-4a5d-4b71-8bd3-79961e7bf4fe	2025-10-20	Warnings	Exact identifier application number: M020
Super Lysine Plus Strawberry Lip Treatment	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	2cafc97f-4cd3-4755-b394-3802c28d4ed5	2025-10-20	Warnings	Exact identifier application number: M020
Super Lysine Plus Tangerine Lip Treatment	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	8a00194e-9e28-4257-82e5-59bc44f7897d	2025-10-20	Warnings	Exact identifier application number: M020
Super Lysine Plus Coldstick	OCTINOXATE AND OXYBENZONE	Quantum, Inc.	c9318a8c-ba3b-4068-84df-110c9005ee1d	2025-10-20	Warnings	Exact identifier application number: M020
Terez Honor Hydro Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	DEWYCREAM INC	418d054b-436f-6aa3-e063-6294a90a0f56	2025-10-19	Warnings	Exact identifier application number: M020
Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50	ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Cosmocos Co., Ltd	41129799-85ed-2de2-e063-6394a90ab40c	2025-10-17	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	c5a67314-e5b2-4dd6-94e9-39c2f286c346	2025-10-17	Warnings	Exact identifier application number: M020
LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREEN	ZINC OXIDE	Lion Pose Inc.	0310407b-fb74-aa8b-e063-6294a90ad841	2025-10-17	Warnings	Exact identifier application number: M020
Thrive Daily Defense Sunscreen Balm SPF30	ZINC OXIDE	Thrive Natural Care, Inc	1266bd05-1971-a7f0-e063-6394a90a089c	2025-10-17	Warnings	Exact identifier application number: M020
AESOP Avail Body Sunscreen Broad Spectrum SPF 50	AVOBENZONE, OCTISALATE, OCTOCRYLENE	Emeis Cosmetics Pty Ltd	2cb40521-94ed-4e76-a4e2-de1c80155bd2	2025-10-17	Warnings	Exact identifier application number: M020
AESOP Avail Facial Sunscreen Broad Spectrum SPF 25	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Emeis Cosmetics Pty Ltd	bff60c2f-0cc6-493b-81a0-ed35e9746146	2025-10-17	Warnings	Exact identifier application number: M020
Mineral Lip Balm Pineapple	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	667714f6-38bc-4c94-aacc-24b46e8e59fd	2025-10-17	Warnings	Exact identifier application number: M020
ELEVEN BY VENUS WILLIAMS GAME SET MATCH BODY	ZINC OXIDE	Eco-Chic LLC	dd2fe82e-31e1-1349-e053-2995a90aa409	2025-10-16	Warnings	Exact identifier application number: M020

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58892-339-45	58892033945	1 TUBE in 1 CARTON (58892-339-45) / 4.5 g in 1 TUBE	1 tube	2022-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG FACTS	Fallien Cosmeceuticals, LTD \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2025-01-09	HUMAN OTC DRUG LABEL	3