TiZO Mineral Sun Defense SPF 50

Product NDC: 58892-128
11-digit product format: 588920128
Labeler code: 58892
Product ID: 58892-128_255398db-bb8d-3d6e-e063-6394a90a2550
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide, Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: Fallien Cosmeceuticals Ltd.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-03-01
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 100; 30 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 Mineral Sun Defense SPF 50
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	100 mg/g
ZINC OXIDE	30 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
e17a8c35-2d49-4c99-b154-ea673c14753e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58892-128-50	TiZO Mineral Sun Defense SPF 50	50 g in 1 TUBE	CREAM	50	2
58892-128-50	TiZO Mineral Sun Defense SPF 50	1 in 1 CARTON	CREAM	1	2
58892-128-05	TiZO Mineral Sun Defense SPF 50	5 g in 1 TUBE	CREAM	5	1
58892-128-15	TiZO Mineral Sun Defense SPF 50	1.5 g in 1 PACKET	CREAM	1.5	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58892-128	TIZO MINERAL SUN DEFENSE SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS LTD.]	2	Current NDC, 2 package rows	20241027_e17a8c35-2d49-4c99-b154-ea673c14753e.zip
58892-128	TIZO MINERAL SUN DEFENSE SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS LTD.]	1	Current NDC, 1 package rows	20250212_2cc8f7ef-eda3-fe71-e063-6394a90a6a9a.zip
58892-128	TIZO MINERAL SUN DEFENSE SPF 50 (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS LTD.]	1	Current NDC, 1 package rows	20250212_2d0766a1-4091-e84a-e063-6394a90a004a.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 176 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Cocoa	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	40e6473a-8363-4503-bde0-6c151296fb34	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Golden Tan	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	7f4a185c-85c7-43bf-8695-c01a3aecec0d	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Natural	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V	383aabdf-3feb-4407-9d85-27c11cb3e78c	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Shell	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V	4585b1c8-e477-44d7-a3ad-a9efc3d699b7	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Soft Ivory	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V	1e9efb61-06ad-4d2d-a81d-46aba72f7514	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- Bisque	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V	ffc421e1-26eb-44e7-b03c-5fab761a51b2	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15 - Natural Tan	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V	3617d26e-a94c-4665-988b-95dbbc527017	2025-10-21	Warnings	Exact identifier application number: M020
Always Liquid Foundation Makeup Sunscreen Broad Spectrum SPF 15- Honey	HOMOSALATE, OCTISALATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	55be05c0-429a-4ae0-bb86-1120bb1905ff	2025-10-21	Warnings	Exact identifier application number: M020
Sun face protector sunscreen broad spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	b8e1ced7-dafa-c71e-e053-2995a90a9550	2025-10-21	Warnings	Exact identifier application number: M020
Jafra Sun sunscreen broad spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	b9316e16-c571-4a5c-e053-2995a90ac6a8	2025-10-21	Warnings	Exact identifier application number: M020
Jafra Sun tinted face protector sunscreen broad spectrum 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Distribuidora Comercial Jafra, S.A. de C.V.	b8df67f8-57d9-ddc1-e053-2995a90a50c6	2025-10-21	Warnings	Exact identifier application number: M020
Sonni SunDay Invisible Defense	TITANIUM DIOXIDE, ZINC OXIDE	Sonni	41ad9658-7906-d04c-e063-6394a90a4723	2025-10-21	Warnings	Exact identifier application number: M020
Sonni SunDay Body Balm	TITANIUM DIOXIDE, ZINC OXIDE	Sonni	41adca2e-cf69-ccd9-e063-6294a90a0dc0	2025-10-21	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE OCTISALATE OCTOCRYLENE	Edgewell Personal Care Brands LLC	0b625d48-9632-0464-e063-6394a90a9adc	2025-10-21	Warnings	Exact identifier application number: M020
e l f Camo Semi Matte CC SPF 30 Deep 530 W	ZINC OXIDE, TITANIUM DIOXIDE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	e.l.f. Cosmetics, Inc.	940e0b2d-0b10-4534-ba36-e9980cead492	2025-10-21	Warnings	Exact identifier application number: M020
UV SOLUTIONS MATTIFYING BROAD SPECTRUM SPF 50	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	CLINIQUE LABORATORIES LLC	4198cfc0-a696-e279-e063-6294a90ac239	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e9d9419-a7e1-bc42-e063-6394a90af511	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e8af968-77d5-1dcd-e063-6394a90a6699	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e9e95c3-4ac8-5962-e063-6294a90a0c02	2025-10-20	Warnings	Exact identifier application number: M020
ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta	ZINC OXIDE	9055-7588 Quebec Inc. DBA Attitude	0e9dd230-b087-cda7-e063-6394a90ae084	2025-10-20	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	Sample	Exclude flag	Status
58892-128-05	58892012805	5 g in 1 TUBE (58892-128-05)	5 g	2023-03-01	Yes	No	Current
58892-128-15	58892012815	1.5 g in 1 PACKET (58892-128-15)	1.5 g	2023-03-01	Yes	No	Current
58892-128-50	58892012850	1 TUBE in 1 CARTON (58892-128-50) / 50 g in 1 TUBE	1 tube	2023-03-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Titanium Dioxide, Zinc Oxide - Fallien Cosmeceuticals Ltd. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	Fallien Cosmeceuticals Ltd. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	2025-01-31	HUMAN OTC DRUG LABEL	1
Titanium Dioxide, Zinc Oxide - Fallien Cosmeceuticals Ltd. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	Fallien Cosmeceuticals Ltd. \| Fragrance Manufacturing Inc. \| Custom Analytics LLC	2025-01-28	HUMAN OTC DRUG LABEL	1
BISMUTH OXYCHLORIDE - Fallien Cosmeceuticals Ltd. \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	Fallien Cosmeceuticals Ltd. \| Custom Analytics LLC \| Fragrance Manufacturing Inc. (FMI)	2024-10-25	HUMAN OTC DRUG LABEL	2