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 175 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AussieZinc Mineral Sunscreen Vegan and Organic Hydrate and Nourish - Medium Tint	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36ca1103-b9bf-2573-e063-6394a90acdc5	2025-10-23	Warnings	Exact identifier application number: M020
AussieZinc Mineral Sunscreen Vegan and Organic Extra Sensitive	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	36ca5334-fd41-297f-e063-6394a90ac72e	2025-10-23	Warnings	Exact identifier application number: M020
Mineral Sun Drops	ZINC OXIDE	Synchronicity Spa, Inc. DBA Suntegrity	d8acda81-4430-42f8-be56-d28bb010e630	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Latte	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c34c1486-fa6c-485f-80b3-98e397b3dddb	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Cool Vanilla	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	74c078ec-a371-4406-8d5e-a0baada3a1a6	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Sandalwood	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	2765f345-eab2-4878-b1f1-f8e243083476	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Toffee	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	d1181543-07ab-4a51-8b55-afc1a98293f6	2025-10-22	Warnings	Exact identifier application number: M020
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 Warm Beige	OCTINOXATE, TITANIUM DIOXIDE	BCM Cosmetique SAS	c7be3a7e-f031-4ec0-b9dc-41c025cd0066	2025-10-22	Warnings	Exact identifier application number: M020
Powder	TITANIUM DIOXIDE	Oxygen Development LLC	41c0c262-21c3-b8e6-e063-6394a90a7c9c	2025-10-22	Warnings	Exact identifier application number: M020
PHOTO FINISH INVISIBLE SPF 45 BROAD SPECTRUM SPF 45 PRIMER	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	SMASHBOX BEAUTY COSMETICS, INC	41c4e135-c6df-82d4-e063-6294a90a0ad3	2025-10-22	Warnings	Exact identifier application number: M020
City Sunscreen serum Broad Spectrum SPF 30 Supergoop	HOMOSALATE, OCTISALATE, AVOBENZENE, OCTOCRYLENE	Baxter Laboratories Pty. Ltd.	a29e5a69-d17e-45ef-8dde-e99c6e4a2b22	2025-10-22	Warnings	Exact identifier application number: M020
Miffy Sunny Defense SPF Stick	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	RBGROUP Co., Ltd	24802b17-c0ba-1075-e063-6394a90addd5	2025-10-21	Warnings	Exact identifier application number: M020
Sunny Defense SPF Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RBGROUP Co., Ltd	18632155-5feb-5759-e063-6294a90ab88c	2025-10-21	Warnings	Exact identifier application number: M020
Paul Frank Sunny Defense SPF Stick	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RBGROUP Co., Ltd	26345203-3393-60ba-e063-6394a90a7e92	2025-10-21	Warnings	Exact identifier application number: M020
Keith Haring Tone Blur Essence Sunscreen	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	RBGROUP Co., Ltd	1d578196-c785-9914-e063-6394a90a0533	2025-10-21	Warnings	Exact identifier application number: M020
luminous aqua sunscreen mist	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	RBGROUP Co., Ltd	29fc0c2b-8d10-8704-e063-6394a90ad504	2025-10-21	Warnings	Exact identifier application number: M020
DEWYTREE URBAN SHADE HYALURONIC LIGHTWEIGHT SUNSCREEN	OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE	DEWYTREE CO. ,LTD	2f1ca6e0-f689-57c7-e063-6394a90a3da5	2025-10-21	Warnings	Exact identifier application number: M020
TOSOWOONG Rice Glow SunScreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	MANTONG Co., Ltd.	3e9120fd-1c2f-1546-e063-6394a90a9e46	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Buff	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	857666da-2b4a-4a4a-aa25-ed6fd9b6a163	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Ivory	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V	62031860-2e28-4b25-82bd-29b874b24d84	2025-10-21	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