Dosage and administration
Apply liberally 15 minutes before sun exposure.
TiZO Ultra Zinc SPF 40 (Tinted)
- Manufacturer
- Fallien Cosmeceuticals, LTD. | Fragrance Manufacturing Inc. | Custom Analytics LLC
- Effective date
- 2025-02-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 00:54:46
Label at a glance#
ProductTiZO Ultra Zinc SPF 40 (Tinted)
Active ingredientZINC OXIDE
Label structure8 sections
Label contents#
Full prescribing information#
Active Ingredients:
Zinc Oxide 20%
Purpose:
Sunscreen
Directions:
Apply liberally 15 minutes before sun exposure.
Warnings:
For external use only. Keep out of the reach of children
Warnings and Directions:
For external use only. Keep out of the reach of children. Apply liberally 15 minutes before sun exposure.
INACTIVE INGREDIENT SECTION
Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water
Warning:
Keep out of the reach of children.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-319-05 | TiZO Ultra Zinc SPF 40 (Tinted) | 5 g in 1 TUBE | CREAM | 5 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- TiZO Ultra Zinc SPF 40 (Tinted)
- Zinc Oxide
- GLYCERIN
- HYDROGEN DIMETHICONE (20 CST)
- SODIUM CHLORIDE
- TRIETHANOLAMINE
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4)
- CYCLOPENTASILOXANE
- MICROCRYSTALLINE WAX
- MICA
- C12-15 ALKYL BENZOATE
- POLYHYDROXYSTEARIC ACID (2300 MW)
- ALPHA-TOCOPHEROL ACETATE
- TETRAHEXYLDECYL ASCORBATE
- POLYSORBATE 20
- CAPRYLYL GLYCOL
- DIMETHICONE CROSSPOLYMER
- POLYGLYCERYL-4 ISOSTEARATE
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- IRON OXIDES
- BISMUTH OXYCHLORIDE
- TRIETHOXYCAPRYLYLSILANE
- WATER
- STEARYL DIMETHICONE (400 MPA.S AT 50C)
- CYCLOHEXASILOXANE
- DIMETHICONE
- PEG-10 DIMETHICONE (600 CST)
- PEG-30 DIPOLYHYDROXYSTEARATE
- CAPRYLHYDROXAMIC ACID
- DIMETHICONOL (2000 CST)
- EDETATE DISODIUM ANHYDROUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-319 | 58892-319-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| TiZO Ultra Zinc SPF 40 (Tinted) | ZINC OXIDE | Fallien Cosmeceuticals, LTD. | 2d3faa43-0d78-58de-e063-6294a90a0b17 | 2025-02-03 | Warnings | 58892-319-05 58892-319 58892031905 2d3faa43-0d79-58de-e063-6294a90a0b17 2d3faa43-0d78-58de-e063-6294a90a0b17 |
| TiZO Ultra Zinc SPF 40 (Tinted) | ZINC OXIDE | Fallien Cosmeceuticals, LTD | 2d0856cf-d3da-5a77-e063-6294a90ad5b4 | 2025-01-31 | Warnings | 58892-319 |
| TiZO Ultra Zinc SPF 40 (Tinted) | ZINC OXIDE | Fallien Cosmeceuticals, LTD | 36efd48b-910e-4b61-9519-a6d5c7e9a7c3 | 2024-10-29 | Warnings | 58892-319 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.