Indications and uses
Helps prevent sunburn Provides protection from UVA & UVB rays that may contribute to premature aging of the skin Retains SPF up to 40 minutes of water immersion or perspiring
Solar Protection Formula TiZO Body
- Manufacturer
- Fallien Cosmeceuticals, LTD. | Process Technologies & Packaging | Custom Analytics LLC
- Effective date
- 2010-09-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:25:46
Label at a glance#
ProductSolar Protection Formula TiZO Body Sunscreen
Active ingredientZinc Oxide
Label structure10 sections
Dosage and administration
Apply generously and uniformly to all exposed skin areas before exposure to sunlight Continue to rub in until fading occurs, especially in hair bearing areas Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
DRUG FACTS
Active Ingredients:
Zinc Oxide 20%
Purpose
Sunscreen
Uses
- Helps prevent sunburn
- Provides protection from UVA & UVB rays that may contribute to premature aging of the skin
- Retains SPF up to 40 minutes of water immersion or perspiring
Warnings
- For external use only
- Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
- Do not use if sensitive to ingredients
- Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
- For use on children less than 6 months of age, consult a doctor
- Keep this and all medicines out of the reach of children
- If swallowed, get medical help or contact a Poison Control Center
Directions
- Apply generously and uniformly to all exposed skin areas before exposure to sunlight
- Continue to rub in until fading occurs, especially in hair bearing areas
- Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection
Other Information
- Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
- May stain some fabrics
Inactive Ingredients:
C12-15 Alkyl Benzoate, Caprylhydroxyamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylysilane, Water
TiZO Body SPF 35 is a sunscreen uniquely formulated to offer sheer, elegant protection with a silky, smooth, matte finish. TiZO Body offers unparalleled aesthetic elegance while providing superb photoprotective performance. Using our proprietary technology, Fallien has formulated multiple particle sizes of micronized zinc oxide into a light, silky texture that dries to a clear, yet matte finish on any complexion. TiZO Body is paraben, oil and fragrance free, and specially formulated without UV absorbing chemicals to offer unsurpassed, irritant free UVA/UVB light protection.
SPF is not Enough
UVA radiation is consistently the same all day and all year long. Everyone requires daily, year round UVA protection. UVA radiation is responsible for deep skin damage that results in most of the changes associated with skin aging, such as wrinkling. In addition, the effects of UVA damage are cumulative. Since the SPF number does not define the level of UVA protection, products that utilize both titanium dioxide and/or zinc oxide, are the best method of assuring full spectrum sun protection from UVA and UVB radiation.
- Excellent for Sensitive Skin
- Free of "Chemical Sunscreen Filters"
- Contains no Parabens
- Dries Translucent
- Full Spectrum Protection
- Fragrance Free
Manufactured exclusively for
Fallien, Ltd.
West Norriton PA 19403
Made in USA
Principal Display Panel – Carton Label
NDC 58892-218-01
SOLAR
PROTECTION
Formula®
TIZO®
BODY
20% Zinc Oxide Mineral Protection
Water Resistant
spf 35
uva/uvb
Net Wt 3.5 oz. / 100g
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58892-218-01 | 2019-10-21 | C162847 | 48780-1 | 956f9ecf-cf1e-621f-e053-dbdaa90a74ad | Solar Protection Formula TiZO Body Sunscreen |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58892-218-01 | Solar Protection Formula TiZO Body Sunscreen | 100 g in 1 BOTTLE | CREAM | 100 | 1 | |
| 58892-218-01 | Solar Protection Formula TiZO Body Sunscreen | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Zinc Oxide | ACTIVE INGREDIENT | SOI2LOH54Z | 1 | |
| Zinc Oxide | ACTIVE MOIETY | SOI2LOH54Z | 1 | |
| .Alpha.-Tocopherol Acetate, D- | INACTIVE INGREDIENT | A7E6112E4N | 1 | |
| C12-15 Alkyl Benzoate | INACTIVE INGREDIENT | A9EJ3J61HQ | 1 | |
| Caprylhydroxamic Acid | INACTIVE INGREDIENT | UPY805K99W | 1 | |
| Caprylyl Glycol | INACTIVE INGREDIENT | 00YIU5438U | 1 | |
| Cyclomethicone 5 | INACTIVE INGREDIENT | 0THT5PCI0R | 1 | |
| Cyclomethicone 6 | INACTIVE INGREDIENT | XHK3U310BA | 1 | |
| Dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 | |
| Edetate Disodium | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | 1 | |
| Hydroxystearic Acid | INACTIVE INGREDIENT | 933ANU3H2S | 1 | |
| Octyltriethoxysilane | INACTIVE INGREDIENT | LDC331P08E | 1 | |
| Polysorbate 20 | INACTIVE INGREDIENT | 7T1F30V5YH | 1 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | 1 | |
| Tetrahexyldecyl Ascorbate | INACTIVE INGREDIENT | 9LBV3F07AZ | 1 | |
| Trolamine | INACTIVE INGREDIENT | 9O3K93S3TK | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Solar Protection Formula TiZO Body Sunscreen
- Zinc Oxide
- C12-15 Alkyl Benzoate
- Caprylhydroxamic Acid
- Caprylyl Glycol
- Cyclomethicone 6
- Cyclomethicone 5
- Dimethicone
- Edetate Disodium
- Glycerin
- Hydroxystearic Acid
- Polysorbate 20
- Sodium Chloride
- Tetrahexyldecyl Ascorbate
- .Alpha.-Tocopherol Acetate, D-
- Trolamine
- Octyltriethoxysilane
- Water
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58892-218 | 58892-218-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Glycerin | GLYCERIN | PDC6A3C0OX | SPONGE / TOPICAL | 2 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SOLUTION, CONCENTRATE / ORAL | 200 mg/1ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / OPHTHALMIC | 58 mg | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | GEL / TOPICAL | 6 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION / RESPIRATORY (INHALATION) | 43 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL | 11 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR | 0.86 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION, SOLUTION / SUBCUTANEOUS | 15 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SOLUTION / SUBCUTANEOUS | 1486 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL | 226 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / PERIDURAL | 8.07 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 45 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | POWDER, FOR SUSPENSION / ORAL | 1.3 mg/5ml | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | JELLY / VAGINAL | NA | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | AEROSOL, METERED / RECTAL | ADJ PH | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION/ DROPS / AURICULAR (OTIC) | 18 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION/ DROPS / OPHTHALMIC | 2.5 %w/v | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | POWDER / TOPICAL | 0.02 mg/mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | GEL / VAGINAL | 10 %w/w | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | SOLUTION / TOPICAL | NA | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | LOTION / TOPICAL | 3990 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | GUM, CHEWING / BUCCAL | 230 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET / ORAL | 100 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, EMULSION / INTRAVENOUS | 0.62 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | TABLET, EXTENDED RELEASE / ORAL | 7 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | SOAP / TOPICAL | 0.02 %w/w | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | OINTMENT / TOPICAL | 1 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | DROPS / OPHTHALMIC | 0.08 %w/w | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 0.02 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAVITREAL | 10 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CREAM / TOPICAL | 1720 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / INTRAVENOUS | 0.05 %w/v | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, SUSPENSION / INTRALESIONAL | 13 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | INJECTION / INTRADERMAL | 1.6 %w/v | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | PASTE / DENTAL | 20 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 1800 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | POWDER, DENTIFRICE / DENTAL | 0.03 mg/mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | INJECTION / INTRAMUSCULAR | 1486 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | TABLET / ORAL | 17 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SUSPENSION / AURICULAR (OTIC) | 0.05 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | SYSTEM / IONTOPHORESIS | 168.1 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SUSPENSION/ DROPS / TOPICAL | 0.23 %w/v | ||
| Trolamine | TROLAMINE | 9O3K93S3TK | LOTION / TOPICAL | 360 mg | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | CREAM / TOPICAL | 108 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | POWDER, FOR SUSPENSION / ORAL | 285 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | GEL / TRANSDERMAL | 1 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | INJECTION / INTRABURSAL | 0.01 %w/v | ||
| Polysorbate 20 | POLYSORBATE 20 | 7T1F30V5YH | GEL / TOPICAL | 5 %w/w | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | OINTMENT / TOPICAL | NA | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / OPHTHALMIC | 4 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | LIQUID / ORAL | 0.5 mg/1ml | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SYSTEM / TOPICAL | 126 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | TABLET, EFFERVESCENT / ORAL | 32 mg | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | TABLET, EXTENDED RELEASE / ORAL | 335.1 mg | ||
| Glycerin | GLYCERIN | PDC6A3C0OX | CAPSULE / ORAL | 3487 mg | ||
| Edetate Disodium | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO / TOPICAL | 1 %w/w | ||
| Sodium Chloride | SODIUM CHLORIDE | 451W47IQ8X | SOLUTION / OPHTHALMIC | 13 mg |
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 |
|---|---|---|---|---|---|---|
| 7dd87237-d76f-45d1-a56d-d340efe81719 | 28ce4b2f-f925-47a6-aa2e-e71cd4658e0d | 2010-09-02 | Warnings | 7dd87237-d76f-45d1-a56d-d340efe81719 28ce4b2f-f925-47a6-aa2e-e71cd4658e0d |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.