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 197 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Nude Beach	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3ac48eef-f651-af96-e063-6294a90a501e	2025-08-14	Warnings	Exact identifier application number: M020
Aruba Aloe Hydrating Aloe Rich Sunscreen SPF 15	AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	Aruba Aloe Balm NV	6a398dad-2fb9-4cdb-86c5-2a392b88f29b	2025-08-13	Warnings	Exact identifier application number: M020
SM SOLMIRAGE SUNCARE Solserum Mineral Sunscreen SPF 40	ZINC OXIDE	ALL THE RAJE, LLC	9ffbd53b-1295-42b4-9cd5-18cbb75921d0	2025-08-13	Warnings	Exact identifier application number: M020
MERIT The Uniform Tinted Mineral Sunscreen Broad Spectrum SPF 45 02 Umber, Bistre	ZINC OXIDE	Power Beauty Co.	2e6eac42-0b70-44ea-e063-6294a90a49f8	2025-08-13	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE/OCTOCRYLENE/OXYBENZONE	Edgewell Personal Care Brands LLC	3c414e9b-6c3e-2c8d-e063-6394a90af4a6	2025-08-13	Warnings	Exact identifier application number: M020
Earth Mama Baby Mineral Sunscreen SPF 40	ZINC OXIDE	Eleeo Brands LLC	3c443347-0134-8c87-e063-6294a90a8046	2025-08-13	Warnings	Exact identifier application number: M020
Earth Mama Baby Face Mineral Sunscreen Stick SPF 40	ZINC OXIDE	Eleeo Brands LLC	3a22f0b9-2d6d-6230-e063-6294a90adf31	2025-08-13	Warnings	Exact identifier application number: M020
Earth Mama Lady Face Tinted Mineral Sunscreen Stick SPF 40	ZINC OXIDE	Eleeo Brands LLC	3c4567d6-879e-f995-e063-6394a90a319f	2025-08-13	Warnings	Exact identifier application number: M020
Silk Screen	TITANIUM DIOXIDE, ZINC OXIDE	Skin Apeel, Inc.	3c457455-b9b1-546b-e063-6294a90a41f6	2025-08-13	Warnings	Exact identifier application number: M020
Earth Mama Tinted Mineral Sunscreen SPF 40	ZINC OXIDE	Eleeo Brands LLC	3c455d29-df4e-f4d5-e063-6394a90a97ba	2025-08-13	Warnings	Exact identifier application number: M020
Baby Bum Mineral 50 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3c470ff8-37d6-a729-e063-6294a90aa525	2025-08-13	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen 1 OZ	ZINC OXIDE	Sun Bum, LLC	3c483d04-8942-5269-e063-6294a90a3881	2025-08-13	Warnings	Exact identifier application number: M020
BANANA BOAT	AVOBENZONE/OCTOCRYLENE/OXYBENZONE	Edgewell Personal Care Brands LLC	3c49c623-47c6-4dc9-e063-6294a90a0096	2025-08-13	Warnings	Exact identifier application number: M020
100% MINERAL SUNSCREEN	100% MINERAL SUNSCREEN	Guangzhou Pallas Cosmetics Co.,Ltd.	3c4a3b41-9183-3835-e063-6394a90aea61	2025-08-13	Warnings	Exact identifier application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 FAIR	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	4443d4e6-bdc9-4547-9189-e94e9e0bdd2d	2025-08-12	Warnings	Exact identifier application number: M020
ERBORIAN CC Red Correct Color Correcting SPF 25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	a6cd16cc-5fe3-41b5-b724-83e469cd4d5e	2025-08-12	Warnings	Exact identifier application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 BRONZE	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	4aa12cf0-0c48-4b40-9c9a-bd50523cce8a	2025-08-12	Warnings	Exact identifier application number: M020
ERBORIAN CC CREME Color Correcting SPF 25 MEDIUM	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	5bdaa149-47aa-40ac-b17a-ea6d29099862	2025-08-12	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS Illuminating 40mL with Pink Algae SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	1dda967c-2d69-8948-e063-6294a90ad2a4	2025-08-12	Warnings	Exact identifier application number: M020
NAKED SUNDAYS CABANA GLOW MINERAL GLOW SERUM DROPS BRONZE 15mL with wild Rosella SPF 50	ZINC OXIDE	NAKED SUNDAYS PTY LTD	24e9a9b8-41ba-123a-e063-6394a90a73cb	2025-08-12	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