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
- 2027-12-31
- 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
- 2027-12-31
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 |
|---|---|---|---|---|---|---|
| Broad Spectrum SPF 30 Sun Stick | BROAD SPECTRUM SPF 30 SUN STICK | Raining Rose, Inc | a35a7973-443b-5247-e053-2a95a90a4459 | 2023-10-23 | Warnings | M020 |
| Cranberry Orange SPF 15 Broad Spectrum Lip Balm | CRANBERRY ORANGE SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a8c3aa41-c9a0-4f64-e053-2995a90a005e | 2023-10-23 | Warnings | M020 |
| Super Mint SPF 15 Broad Spectrum Lip Balm | SUPER MINT SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a9626a2f-9931-78d2-e053-2995a90ac40f | 2023-10-23 | Warnings | M020 |
| Spearmint SPF 30 Broad Spectrum Lip Balm | SPEARMINT SPF 30 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | b7b520dc-bae6-614f-e053-2995a90ae677 | 2023-10-23 | Warnings | M020 |
| Citrus SPF 15 Broad Spectrum Lip Balm | CITRUS SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a75d0651-6001-29ce-e053-2a95a90a967f | 2023-10-23 | Warnings | M020 |
| Coconut Mineral SPF 15 Broad Spectrum Lip Balm | COCONUT MINERAL SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | b7b542fa-b0d2-7b33-e053-2995a90a7119 | 2023-10-23 | Warnings | M020 |
| Vanilla SPF 30 Broad Spectrum Lip Balm | VANILLA SPF 30 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | b7b542fa-b0c2-7b33-e053-2995a90a7119 | 2023-10-23 | Warnings | M020 |
| Pineapple Mineral SPF 15 Broad Spectrum Lip Balm | PINEAPPLE MINERAL SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | b7c6684f-1122-20c1-e053-2995a90ae6cf | 2023-10-23 | Warnings | M020 |
| Farmasi CC Cream LIGHT to MEDIUM 02 | TITANIUM DIOXIDE | TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI | 28b3fdff-1986-4048-9ed5-a3d784a4014e | 2023-10-23 | Warnings | M020 |
| Farmasi CC Cream- MEDIUM 03 | TITANIUM DIOXIDE | TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI | 65de3c45-8ec2-4d73-8a29-6203d3b47bd7 | 2023-10-23 | Warnings | M020 |
| Farmasi BB Cream- MEDIUM 03 | TITANIUM DIOXIDE | TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI | 9102aa2f-0308-4985-b8a8-8e105047b61f | 2023-10-23 | Warnings | M020 |
| Caribbean Breeze SPF 15 Broad Spectrum Lip Balm | CARIBBEAN BREEZE SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a75a42f6-27d1-e2cc-e053-2a95a90aa6da | 2023-10-23 | Warnings | M020 |
| Iced Pear SPF 15 Broad Spectrum Lip Balm | ICED PEAR SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a8c4a0ec-e07e-1cda-e053-2a95a90a0f3f | 2023-10-23 | Warnings | M020 |
| Lemonade SPF 15 Broad Spectrum Lip Balm | LEMONADE SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a8ffc32b-b758-0f8f-e053-2995a90adb62 | 2023-10-23 | Warnings | M020 |
| Strawberry SPF 15 Broad Spectrum Lip Balm | STRAWBERRY SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a902d590-0726-ad6f-e053-2995a90a1130 | 2023-10-23 | Warnings | M020 |
| Orange Creamsicle SPF 15 Broad Spectrum Lip Balm | ORANGE CREAMSICLE SPF 15 BROAD SPECTRUM LIP BALM | Raining Rose, Inc | a9005cb1-ae1a-7736-e053-2995a90a28ea | 2023-10-23 | Warnings | M020 |
| Neora Age IQ Invisi-Bloc Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Neora, LLC | f2f3601f-081a-4bae-e053-2a95a90a4fac | 2023-10-23 | Warnings | M020 |
| Neora Age IQ Invisi-Bloc Sunscreen | AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE | Neora, LLC | 82f48635-1dc4-8c0d-e053-2991aa0a60cc | 2023-10-23 | Warnings | M020 |
| Artistry Exact Fit Longwearing Foundation Shade Golden L4N1 | TITANIUM DIOXIDE | Amway Corp | 7494fe09-40e0-4152-9974-a6e8a4d7f421 | 2023-10-22 | Warnings | M020 |
| Artistry Exact Fit Longwearing Foundation Shade Soleil L3W1 | TITANIUM DIOXIDE | Amway Corp | cec51b88-a6b8-4b64-b3aa-830e712a3c8a | 2023-10-22 | 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 |