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.
TiZO3
- Manufacturer
- Fallien Cosmeceuticals, LTD | Custom Analytics LLC | Fragrance Manufacturing Inc. (FMI)
- Effective date
- 2024-10-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:22:27
Label at a glance#
ProductTiZO3
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure9 sections
Dosage and administration
Apply liberally 15 minutes before sun exposure. Reapply: After 80 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 protect...
Label contents#
Full prescribing information#
Active Ingredients:
Titanium Dioxide 8%
Zinc Oxide 3.8%
Purpose
Sunscreen
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.
OTC - STOP USE SECTION
Stop use and ask a doctor if rash occurs.
OTC - WHEN USING SECTION
When using this product keep out of eyes. Rinse with water to remove.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 80 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 lime in the sun, especially from 10 am-2 pm
- Wear long-sleeved shirts, pants, hats, and sunglasses
Inactive Ingredients:
Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (Cl 77491), Lauryl PEG/ PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate
Other Information:
- Protect this product from excessive heat and direct sun - May stain some fabrics
Principal Display Panel - 50 g Carton Label
TiZO®3
PRIMER/
SUNSCREEN
Tinted
SPF
40
PA+++
FACIAL
MINERAL SUNSCREEN
Titanium & Zinc Oxides
Antioxidants C & E
Sheer Matte Finish
Broad Spectrum SPF 40
Water Resistant (80 Minutes)
Net Wt. 1.75 Oz./50 g
Principal Display Panel - 50 g Tube Label
TiZO®3
PRIMER/
SUNSCREEN
Tinted
SPF
40
PA+++
FACIAL
MINERAL SUNSCREEN
With Antioxidants C & E
Broad Spectrum SPF 40
Water Resistant (80 Minutes)
Net Wt. 1.75 Oz./50 g
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58892-326-50 | 2024-10-02 | C162847 | 48780-1 | 1030e365-68ea-111a-e063-dadaa90a10e2 | DRUG FACTS |
| 58892-326-50 | 2024-01-30 | C162847 | 48780-1 | 1030e365-68ea-111a-e063-dadaa90a10e2 | DRUG FACTS |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-326-50 | TiZO3 | 44.4 mL in 1 TUBE | CREAM | 44.4 | 4 | |
| 58892-326-50 | TiZO3 | 1 in 1 CARTON | CREAM | 1 | 4 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- TiZO3
- Titanium Dioxide, Zinc Oxide
- Titanium Dioxide
- Zinc Oxide
- Aluminum Hydroxide
- Cyclomethicone 6
- Cyclomethicone 5
- Dimethicone 20
- Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane)
- Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle)
- Dimethiconol (2000 CST)
- Brown Iron Oxide
- Lauryl PEG/PPG-18/18 Methicone
- Hydrogen Dimethicone (20 CST)
- PEG-10 Dimethicone (600 CST)
- Tetrahexyldecyl Ascorbate
- .Alpha.-Tocopherol Acetate
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-326 | 58892-326-50 |
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 |
|---|---|---|---|---|---|---|
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, LTD | 4e7bdec2-abcc-0267-e063-6394a90ae47a | 2026-04-02 | Warnings | 58892-326 |
| TiZO3 | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals Ltd. | 468d6476-127a-e9f0-e063-6294a90a3df9 | 2025-12-22 | Warnings | 58892-326 |
| d20b0fce-eb08-453b-ae48-2f8b90eba8f7 | 2e53defe-98a3-4689-8763-35d76b5701c3 | 2024-10-01 | Warnings | d20b0fce-eb08-453b-ae48-2f8b90eba8f7 2e53defe-98a3-4689-8763-35d76b5701c3 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.