Indications and uses
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
TiZO Ultra Zinc SPF 40 (Tinted)
- Manufacturer
- Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
- Effective date
- 2024-10-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:31:45
Label at a glance#
ProductTiZO Ultra Zinc SPF 40 (Tinted)
Active ingredientZINC OXIDE
Label structure10 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protectio...
Label contents#
Full prescribing information#
Active Ingredients:
Zinc Oxide 20%
Purpose
Sunscreen
Uses:
Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings:
For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove.
Keep out of the reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions:
Apply liberally 15 minutes before sun exposure. Reapply:
- After 40 minutes of swimming or sweating
- Immediately after towel drying
- At least every 2 hours
- Children under 6 months: Ask a doctor
- Sun Protection Measures:Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 am-2 pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients:
Bismuth Oxychloride, C 12-15Alkyl 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
Other Information:
- Protect this product from excessive heat and direct sun
- May stain some fabrics
- Shake well before use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
Principal Display Panel - TiZO Ultra Zinc SPF 40 Carton Label
TiZO®
ULTRA ZINC
Tinted
SPF
40
MINERAL SUNSCREEN
FOR BODY & FACE
20% Zinc Oxide
Antioxidants C & E
Moisturizing
Broad Spectrum SPF 40
Water Resistant (40 Minutes)
Net Wt. 3.5 Oz./100 g
Principal Display Panel - TiZO Ultra Zinc SPF 40 Tube Label
TiZO®
ULTRA ZINC
Tinted
SPF
40
MINERAL SUNSCREEN
FOR BODY & FACE
With Antioxidants C & E
Broad Spectrum SPF 40
Water Resistant (40 Minutes)
Net Wt. 3.5 Oz./100 g
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 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- TiZO Ultra Zinc SPF 40 (Tinted)
- Zinc Oxide
- BISMUTH OXYCHLORIDE
- ALKYL (C12-15) BENZOATE
- CAPRYLHYDROXAMIC ACID
- CAPRYLYL GLYCOL
- CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)
- CYCLOMETHICONE 6
- CYCLOMETHICONE 5
- DIMETHICONE 100
- DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
- DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
- DIMETHICONOL (2000 CST)
- EDETATE DISODIUM
- GLYCERIN
- FERRIC OXIDE RED
- FERRIC OXIDE YELLOW
- FERROSOFERRIC OXIDE
- HYDROGEN DIMETHICONE (20 CST)
- MICA
- MICROCRYSTALLINE WAX
- PEG-10 DIMETHICONE (600 CST)
- PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW)
- POLYGLYCERYL-4 ISOSTEARATE
- POLYHYDROXYSTEARIC ACID (2300 MW)
- POLYSORBATE 20
- SODIUM CHLORIDE
- STEARYL DIMETHICONE (400 MPA.S AT 50C)
- TETRAHEXYLDECYL ASCORBATE
- .ALPHA.-TOCOPHEROL ACETATE
- TROLAMINE
- TRIETHOXYCAPRYLYLSILANE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-319 | 58892-319-01 |
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 |
| 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 | 58892-319-01 58892-319 58892031901 25a288aa-1828-492a-e063-6294a90ae5c3 36efd48b-910e-4b61-9519-a6d5c7e9a7c3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.