TiZO Ultra Zinc SPF 40 (Tinted)
- Product NDC
- 58892-319
- 11-digit product format
- 588920319
- Labeler code
- 58892
- Product ID
- 58892-319_25a288aa-1828-492a-e063-6294a90ae5c3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Zinc Oxide
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Fallien Cosmeceuticals, LTD
- Application
- M020
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2015-01-15
- Substance
- ZINC OXIDE
- Active strength
- 200 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 Ultra Zinc SPF 40 (Tinted)
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ZINC OXIDE | 200 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| SOI2LOH54Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 36efd48b-910e-4b61-9519-a6d5c7e9a7c3 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-319-01 | TiZO Ultra Zinc SPF 40 (Tinted) | 100 g in 1 TUBE | CREAM | 100 | 4 | |
| 58892-319-01 | TiZO Ultra Zinc SPF 40 (Tinted) | 1 in 1 CARTON | CREAM | 1 | 4 | |
| 58892-319-05 | TiZO Ultra Zinc SPF 40 (Tinted) | 5 g in 1 TUBE | CREAM | 5 | 1 | |
| 58892-319-15 | TiZO Ultra Zinc SPF 40 (Tinted) | 1.5 g in 1 PACKET | CREAM | 1.5 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58892-319 | TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241031_36efd48b-910e-4b61-9519-a6d5c7e9a7c3.zip |
| 58892-319 | TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.] | 1 | Current NDC, Legacy NDC, 1 package rows | 20250212_2d3faa43-0d78-58de-e063-6294a90a0b17.zip |
| 58892-319 | TIZO ULTRA ZINC SPF 40 (TINTED) (ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD] | 1 | Current NDC, Legacy NDC, 1 package rows | 20250212_2d0856cf-d3da-5a77-e063-6294a90ad5b4.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Environ Skin Care RAD Shield Mineral Sunscreen SPF 30 | SUNSCREEN | ENVIRON SKIN CARE (PTY) LTD | 3778547e-11a8-3b30-e063-6394a90ab5b1 | 2025-06-13 | Warnings | M020 |
| Voupre Age Defense | OCTINOXATE, HOMOSALATE, OCTISALATE, OXYBENZONE AND AVOBENZONE | Innovation Brands Inc. | 8dfaa076-c62a-47ee-bc5d-75360416fa1a | 2025-06-13 | Warnings | M020 |
| Instantly Dry | TITANIUM DIOXIDE, ZINC OXIDE | CLEAN BEAUTY BY ANAK LLC | 37624bf6-4949-1b10-e063-6294a90ac488 | 2025-06-12 | M020 | |
| silk SPF facial sunscreen fluid hybrid broad spectrum SPF 30 UVA/UVB | ZINC OXIDE AND HOMOSALATE | OneKind.25 | d739bc43-d76e-9258-e053-2a95a90a3d2c | 2025-06-12 | Warnings | M020 |
| ULTRA SHEER DAILY DEFENSE FACIAL SPF 18 | HOMOSALATE, OCTISALATE, AND AVOBENZONE | Andalou naturals | 0f7c6d3a-73ea-44d8-a8b9-6a6f1bb02c6f | 2025-06-11 | Warnings | M020 |
| Hydrating Sheer Lip Balm Trio The Vivids Broad Spectrum SPF 30 | AVOBENZONE, OCTISALATE, AND HOMOSALATE | MDSolarSciences | 374e770f-75b5-08d0-e063-6394a90adf92 | 2025-06-11 | Warnings | M020 |
| Reflecting Mineral Sunscreen | ZINC OXIDE, TITANIUM DIOXIDE | Helande, LLC | 3750f04b-7f9f-8793-e063-6294a90a9143 | 2025-06-11 | Warnings | M020 |
| Vitamin C BB Beauty Balm Sheer Tint SFP 30 | ZINC OXIDE | Andalou naturals | f423b484-2119-4c95-a0da-77bcd07303eb | 2025-06-11 | Warnings | M020 |
| Perfecting BB Beauty Balm Natural Tint SPF 30 | ZINC OXIDE | Andalou naturals | 16ca3790-9973-4a04-a43c-e0f7b384f147 | 2025-06-11 | Warnings | M020 |
| SOME BY MI V10 HYAL LIP SUN PROTECTOR | AVOBENZONE, HOMOSALATE, OCTISALATE | PERENNEBELL Co., Ltd. | 3690af2b-fe22-3a9a-e063-6294a90a709d | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 COOL/DEEP | Pacifica Beauty, LLC | 373901f7-0e32-0f32-e063-6394a90abe25 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/TAN | Pacifica Beauty, LLC | 37397b96-ef14-9098-e063-6294a90aafc9 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 WARM/LIGHT | Pacifica Beauty, LLC | 373aba7c-2ae1-8726-e063-6294a90ae3d8 | 2025-06-10 | Warnings | M020 |
| Zinc Oxide | PACIFICA ULTRA CC CREAM RADIANT FOUNDATION SPF 30 NATURAL/MEDIUM | Pacifica Beauty, LLC | 373c29b9-2f75-9777-e063-6394a90a68a6 | 2025-06-10 | Warnings | M020 |
| Hydrating Sheer Lip Balm Trio The Neutrals Broad Spectrum SPF 30 | AVOBENZONE, OCTISALATE, AND HOMOSALATE | MDSolarSciences | 374395ea-ab91-de70-e063-6394a90aec56 | 2025-06-10 | Warnings | M020 |
| ANDALOU NATURALS DEEP HYDRATION DAILY SHADE BLUE LIGHT DEFENSE FACIAL SPF 30 | ZINC OXIDE | Andalou naturals | aa689e82-6512-46d8-aec9-269f9348d3f8 | 2025-06-09 | Warnings | M020 |
| ALLIES OF SKIN The One SPF-50 Invisible Sunscreen | AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE | ALLIES GROUP PTE. LTD. | 36e1c61c-33ab-4a5d-853d-119c29632b08 | 2025-06-09 | Warnings | M020 |
| SHISEIDO ULTIMATE SUN PROTECTION S | TITANIUM DIOXIDE AND ZINC OXIDE | Shiseido Americas Corporation | b2fae1ba-67fe-48ef-b31f-62db34349961 | 2025-06-09 | Warnings | M020 |
| Olay Super Cream with Sunscreen Broad Spectrum SPF 30 | AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE | The Procter & Gamble Manufacturing Company | 372819f1-0813-2cd5-e063-6294a90ac5bf | 2025-06-09 | Warnings | M020 |
| Naturium Phyto-Glow Lip Balm SPF 45-Clear | AVOBENZONE, HOMOSALATE, OCTISALATE | e.l.f. Cosmetics, Inc. | 3806e2f2-ffd1-6d69-e063-6394a90acb44 | 2025-06-09 | Warnings | M020 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 58892-319-01 | 58892031901 | 1 TUBE in 1 CARTON (58892-319-01) / 100 g in 1 TUBE | 1 tube | 2022-03-15 | 0000-00-00 | No | No | Current |
| 58892-319-05 | 58892031905 | 5 g in 1 TUBE (58892-319-05) | 5 g | 2022-03-15 | Yes | No | Current | |
| 58892-319-15 | 58892031915 | 1.5 g in 1 PACKET (58892-319-15) | 1.5 g | 2022-03-15 | Yes | No | Current |