OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS:
Titanium Dioxide 3%
Zinc Oxide 10%
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen
- Manufacturer
- Fallien Cosmeceuticals, Ltd | Tri-Pac Inc | Custom Analytics LLC
- Effective date
- 2024-08-09
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 4
- Source
- full-release
- Hydrated at
- 2026-06-01 00:17:01
Label at a glance#
ProductProceuticals Private Label by TiZO non-tinted foaming mineral sunscreen
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure9 sections
Label contents#
Full prescribing information#
OTC - PURPOSE SECTION
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 aging
caused by the sun.
INDICATIONS & USAGE SECTION
DIRECTIONS:
• Shake well before using.
• Press nozzle carefully during first use
• 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 INGREDIENT SECTION
INACTIVE INGREDIENTS:Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl
Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium
EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Isododecane, Isohexadecane,
Methyl Methacrylate Crosspolymer, Microcrystalline Cellulose, Octyldodecyl
Erucate, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate
80, Trans-1,3,3,3-Tetrafluoropropene, Tricontanyl PVP, Triethoxycaprylylsilane,
Water
OTHER SAFETY INFORMATION
OTHER INFORMATION:
• Protect this product from excessive heat and direct sun.
• Store between 68° to 104° F (20° to 40° C).
• Do not store at temperatures above 120° F.
WARNINGS SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of the reach of children.
DOSAGE & ADMINISTRATION SECTION
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.
Apply liberally 15 minutes befor sun exposure.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel – 100g Can Label
PROCEUTICALS
PRIVATE LABEL by TiZO
non-tinted foaming
mineral sunscreen
broad spectrum spf 30
water resistant (40 minutes)
net wt. 3.5 oz/ 100 g
Graphic-Untitled
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-211-01 | Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen | 100 g in 1 CAN | AEROSOL, FOAM | 100 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58892-211 | PROCEUTICALS PRIVATE LABEL BY TIZO NON-TINTED FOAMING MINERAL SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) AEROSOL, FOAM [FALLIEN COSMECEUTICALS, LTD] | 4 | Current NDC, 1 package rows | 20240810_1f4491ab-95b0-cc14-e063-6394a90a73ca.zip |
Products#
Every source-derived product name is available through these pages.
- Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen
- Titanium Dioxide, Zinc Oxide
- CETOSTEARYL ALCOHOL
- GLYCERETH-26
- TRIETHOXYCAPRYLYLSILANE
- TITANIUM DIOXIDE
- POLYOXYL 20 CETOSTEARYL ETHER
- POLY(METHYL METHACRYLATE; 450000 MW)
- GLYCERYL MONOSTEARATE
- EDETATE DISODIUM ANHYDROUS
- ISODODECANE
- OCTYLDODECYL NEOPENTANOATE
- CITRIC ACID MONOHYDRATE
- OCTYLDODECYL ERUCATE
- 1,3,3,3-TETRAFLUOROPROPENE, (1E)-
- POLYSORBATE 80
- METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER
- MICROCRYSTALLINE CELLULOSE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- BUTYLOCTYL SALICYLATE
- TRIACONTANYL PVP (WP-660)
- CAPRYLYL GLYCOL
- ALKYL (C12-15) BENZOATE
- POLYHYDROXYSTEARIC ACID (2300 MW)
- WATER
- CAPRYLHYDROXAMIC ACID
- GLYCERIN
- ZINC OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-211 | 58892-211-01 |
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 |
|---|---|---|---|---|---|---|
| Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen | TITANIUM DIOXIDE, ZINC OXIDE | Fallien Cosmeceuticals, Ltd | 1f4491ab-95b0-cc14-e063-6394a90a73ca | 2024-08-09 | Warnings | 58892-211-01 58892-211 58892021101 1f44ac28-b032-ccff-e063-6394a90a4198 1f4491ab-95b0-cc14-e063-6394a90a73ca |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.