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 101 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 45	SUNSCREEN OIL	Soleil Collective LLC	471c0eed-f7ca-3c3b-e063-6294a90ad2c6	2025-12-29	Warnings	Exact identifier application number: M020
EIGHT HOUR NOURISHING LIP SPF 20	OCTINOXATE, AVOBENZONE	REVLON	b3c16e60-752d-6eba-e053-2995a90a2b20	2025-12-29	Warnings	Exact identifier application number: M020
CERAMIDE PREMIERE BROAD SPECTRUM SPF 30	OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE	REVLON	b3358bfd-7fe5-33e2-e053-2a95a90ac2ea	2025-12-29	Warnings	Exact identifier application number: M020
Prevage anti aging SPF 30	OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE,	Revlon	b2bff796-1579-2686-e053-2995a90ad6c7	2025-12-29	Warnings	Exact identifier application number: M020
FLAWLESS FUTURE SPF 30	OCTINOXATE, OCTISALATE, OXYBENZONE, AVAOBENZONE	REVLON	b553aec1-5002-3a3f-e053-2995a90a22e5	2025-12-29	Warnings	Exact identifier application number: M020
Prevage Anti-aging eye cream SPF 15	OCTINOXATE, OXYBENZONE	Revlon	b2a92d72-e634-7379-e053-2995a90a2bca	2025-12-29	Warnings	Exact identifier application number: M020
Prevage Anti-aging Moisture Cream	OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONE	Revlon Consumer Products Corp	b247adbe-dfe8-df0a-e053-2995a90a34d9	2025-12-29	Warnings	Exact identifier application number: M020
Sheer Protection SPF 30	ZINC OXIDE	Skin Script, LLC	0450dcc9-3f8f-e2c2-e063-6294a90af60b	2025-12-29	Warnings	Exact identifier application number: M020
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	897b8edb-f089-4a49-baca-e05806b0a068	2025-12-29	Warnings	Exact identifier application number: M020
Mine Line Coconut Sunscreen SPF 50	ZINC OXIDE	Spa de Soleil	4642b1cc-43b1-6997-e063-6394a90ac764	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 30 Broad Spectrum Sunscreen	SPF 30 BROAD SPECTRUM SUNSCREEN	SnugZ/USA, LLC	69ac1218-76e6-04ff-e053-2a91aa0a4080	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 50 Sunscreen Spry	SPF 50 SUNSCREEN SPRAY	SnugZ USA	9390ea21-9f9f-14e2-e053-2a95a90ac577	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 15 Flavored Beeswax Lip Balm	SPF 15 FLAVORED BEESWAX LIP BALM	SnugZ/USA, LLC	69bdfaaf-d49e-bf31-e053-2a91aa0affd3	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 50 Broad Spectrum Sunscreen	SPF 50 BROAD SPECTRUM SUNSCREEN	SnugZ/USA, LLC	b7a3eed5-c8ca-ffda-e053-2a95a90a73bb	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 15 Beeswax Lip Balm	SPF 15 BEESWAX LIP BALM	SnugZ/USA, LLC	68816d3a-dbe9-7ce3-e053-2a91aa0a395e	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 30 Soy Lip Balm	SPF 30 SOY LIP BALM	SnugZ/USA, LLC	687ff49d-2d0e-2534-e053-2991aa0a2864	2025-12-29	Warnings	Exact identifier application number: M020
SnugZ SPF 50 Sunscreen Stick	SPF 50 SUNSTICK	SnugZ/USA, LLC	6e1179cf-5bfb-1156-e053-2991aa0a5b46	2025-12-29	Warnings	Exact identifier application number: M020
OUHOE Face Body Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	46d36f60-2a5d-816e-e063-6294a90a2ddc	2025-12-26	Warnings	Exact identifier application number: M020
OUHOE Bean Sunscreen	TITANIUM DIOXIDE	Shantou Ouhoe Technology Co., Ltd.	46d3b11f-93d9-0e38-e063-6294a90a41c3	2025-12-26	Warnings	Exact identifier application number: M020
Cream	ZINC OXIDE	MONAT GLOBAL CORP	e922d89c-4232-77d8-e053-2995a90a85e5	2025-12-26	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