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 191 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Everlast Foundation SPF 20 34W Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	3a239897-9850-417f-8c00-e810a52540c1	2025-08-29	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 36N Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c495afc3-6486-4652-b743-958f28eccaca	2025-08-29	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 35W Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	5440ed13-b07e-4c81-a407-d9ac68eaa483	2025-08-29	Warnings	Exact identifier application number: M020
Dolce and Gabbana Everlast Foundation SPF 20 37W Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	9b2c4567-fde7-4b76-9988-b2cba2d3747e	2025-08-29	Warnings	Exact identifier application number: M020
Neutrogena Hydro Boost Hyaluronic Acid Moisturizer Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	3abd12f4-cbe3-4dd7-e063-6394a90a50a2	2025-08-28	Warnings	Exact identifier application number: M020
Sun Bum 15 Premium Moisturizing Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3d49b054-9f49-17d1-e063-6294a90a757a	2025-08-28	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2	ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3d55291c-9d4c-85c3-e063-6394a90af330	2025-08-27	Warnings	Exact identifier application number: M020
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3	ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3d565612-ade5-bfb3-e063-6294a90a0c65	2025-08-27	Warnings	Exact identifier application number: M020
Jack Black Double Duty	AVOBENZONE OCTOCRYLENE	Jack Black L.L.C.	36d81d6d-4f9b-692d-e063-6294a90ad559	2025-08-27	Warnings	Exact identifier application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Sandbar	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3ac57c70-9298-cbe7-e063-6394a90aefc1	2025-08-27	Warnings	Exact identifier application number: M020
Sun Bum 30 Mineral Tinted Sunscreen Face	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a290aad-7f40-cb10-e063-6394a90a2e69	2025-08-27	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 30 sunscreen	HOMOSALATE 7.5%, OCTISALATE 5.0%, AVOBENZONE 3.0%	Florida Squeezed	a01f0ab9-d686-4ee1-be39-fd4c061cb018	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum 50 Mineral Sunscreen Face Stick	ZINC OXIDE	Sun Bum, LLC	3d48d467-4b6b-c477-e063-6294a90a5a0d	2025-08-26	Warnings	Exact identifier application number: M020
PAPATUI Facial Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	PAPATUI, LLC	3d4ab3a5-a29b-bdd9-e063-6294a90a542c	2025-08-26	Warnings	Exact identifier application number: M020
Broad Spectrum SPF 50 sunscreen	HOMOSALATE 10%, OCTISALATE 5.0%, AVOBENZONE 3.0%	Florida Squeezed	34ffc25c-16e3-4c7c-9d46-9d9f279c074b	2025-08-26	Warnings	Exact identifier application number: M020
Premium Moisturizing Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	36da7117-1c8e-7fcf-e063-6294a90aed00	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	36dc7c13-eaf7-b415-e063-6294a90a5784	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum Face 50 Premium Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c1b7f0c-fdc2-df22-e063-6294a90aed41	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum Mist 45 Refreshing Sunscreen 3.4 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c1c8b83-f37d-a29d-e063-6294a90a20a8	2025-08-26	Warnings	Exact identifier application number: M020
Sun Bum 15 Premium Sunscreen Tanning Oil	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3c468710-ca71-79be-e063-6394a90a8cfd	2025-08-26	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