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 228 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COOLA Classic Body SPF 50 Guava Mango	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	COOLA, LLC	ed13afaa-35ec-8326-e053-2995a90adaf0	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Light)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e21f5bb-e7df-b43b-e063-6394a90a0f82	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Fair)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e2102c6-02ea-3a8f-e063-6394a90abf5e	2025-02-14	Warnings	Exact identifier application number: M020
Sunscreen Broad Spectrum SPF 50 Vi Aesthetics	ZINC OXIDE, OCTINOXATE	Vi Medical Products, INC	73620765-c7c0-4bd7-82a9-00022773c928	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Medium)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e2297d4-3649-a749-e063-6294a90ac284	2025-02-14	Warnings	Exact identifier application number: M020
Sun Defense Minerals (Light)	ZINC OXIDE, TITANIUM DIOXIDE	Eminence Organic Skin Care	2e22cfde-10a1-3742-e063-6394a90ac097	2025-02-14	Warnings	Exact identifier application number: M020
Cell Fusion C Derma UV Mineral Sunscreen Broad Spectrum SPF 50	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	CMS LAB Inc.	2e5c2add-8ed0-a990-e063-6394a90a87ea	2025-02-14	Warnings	Exact identifier application number: M020
Les Duets - Shield of Helios, sunscreen SPF50	ZINC OXIDE SUNSCREEN	VEGANIC SKN LIMITED	385f75a5-6a3b-a129-e063-6394a90a52a0	2025-02-14	Warnings	Exact identifier application number: M020
Le Mieux Naked Glow Bronzer SPF 50	SUNSCREEN	YB CHEMIA LLC	46465db7-c1f0-6980-e063-6294a90a3ed8	2025-02-14	Warnings	Exact identifier application number: M020
Sheer Tint Mineral SPF Serum - Light Light	ZINC OXIDE	Mineral Fusion brands	ac6fdc35-82f8-4805-875e-2aa91aedec6f	2025-02-14	Warnings	Exact identifier application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 50	ZINC OXIDE	Peer Pharm Ltd.	3989eebc-7262-4cda-84a1-ca30b638b772	2025-02-13	Warnings	Exact identifier application number: M020
Fre Protect Me Lightweight Daily Moisturizer SPF 30	ZINC OXIDE	Peer Pharm Ltd.	8ee9f97b-9081-4e0c-aa7a-27a31cbee17a	2025-02-13	Warnings	Exact identifier application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Medium Deep	ZINC OXIDE	Peer Pharm Ltd.	45ed56e1-46cb-46de-b11a-e814a7446e57	2025-02-13	Warnings	Exact identifier application number: M020
Fre Glow Me Lightweight Tinted Moisturizer Light Medium	ZINC OXIDE	Peer Pharm Ltd.	6815f8d6-0d78-4d4d-8d8c-6a1153a5f61a	2025-02-13	Warnings	Exact identifier application number: M020
Neutrogena Mineral Ultra Sheer Dry Touch SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	e99311c2-ed8b-6e60-e053-2a95a90a9bc2	2025-02-13	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	525f7bae-44b8-44e4-93ea-32995eca2566	2025-02-13	Warnings	Exact identifier application number: M020
DreamBeam Sunscreen Sunlit	SUNSCREEN ZINC OXIDE	Kosas Cosmetics, LLC	2e093b82-2a36-cc0f-e063-6394a90a4d6d	2025-02-13	Warnings	Exact identifier application number: M020
DreamBeam Sunscreen	SUNSCREEN ZINC OXIDE	Kosas Cosmetics, LLC	f93b0091-6a41-ae6e-e053-6394a90a86d7	2025-02-13	Warnings	Exact identifier application number: M020
Revealer Skin-Improving Foundation	SUNSCREEN ZINC OXIDE	Kosas Cosmetics, LLC	2e0a0cd6-c302-2017-e063-6394a90a60b8	2025-02-13	Warnings	Exact identifier application number: M020
Hi papa KIDS MINERAL FACE SUNSCREEN	SUNSCREEN	GUANG DONG 3 INS TECHNOLOGY Co., Ltd	2deea723-32a0-da33-e063-6294a90accdd	2025-02-12	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