FDA.reportPublic FDA data

Solar Protection Formula TiZO3

Manufacturer
Fallien Cosmeceuticals, LTD. | Custom Analytics LLC | Process Technologies & Packaging
Effective date
2012-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:33:56

Label at a glance#

ProductSolar Protection Formula TiZO3 Sunscreen
Active ingredientTitanium Dioxide, Zinc Oxide
Label structure9 sections

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.

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 protectio...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 8%

Zinc Oxide 3.8%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Uses:

INDICATIONS & USAGE 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.

Warnings:

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

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:

DOSAGE & ADMINISTRATION SECTION

  • 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 time in the sun, especially from 10:00 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimothiconol, Iron Oxide (CI77491), Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone

Other Information:

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
  • Cleanse thoroughly at nighttime

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Panel – Carton Label

NDC 58892-326-20

SOLAR
PROTECTION
FORMULA®

TIZO3® protection

Facial Mineral Fusion

SPF 40
Broad Spectrum
Water Resistant
(80 minutes)

1.5 Fl. Oz./ 44.4 ml

Principal Display Panel – Carton Label
Principal Display Panel – Carton Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58892-326-202019-11-27C16284748780-19855d018-e65d-cd31-e053-dbdaa90ab51aa5d22c0f-c55b-4344-ba7f-1b40d3b7c5a3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58892-326-20Solar Protection Formula TiZO3 Sunscreen44.4 mL in 1 TUBECREAM44.42
58892-326-20Solar Protection Formula TiZO3 Sunscreen1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58892-326SOLAR PROTECTION FORMULA TIZO3 SUNSCREEN (TITANIUM DIOXIDE, ZINC OXIDE) CREAM [FALLIEN COSMECEUTICALS, LTD.]2Current NDC, Legacy NDC, 2 package rows20121208_a5d22c0f-c55b-4344-ba7f-1b40d3b7c5a3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP2
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z2
Titanium DioxideACTIVE MOIETY15FIX9V2JP2
Zinc OxideACTIVE MOIETYSOI2LOH54Z2
Aluminum OxideINACTIVE INGREDIENTLMI26O69332
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R2
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O2
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G6752

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58892-32658892-326-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
Aluminum OxideLMI26O6933IACT
Cyclomethicone 50THT5PCI0RIACT
Dimethicone92RU3N3Y1OIACT
Ferric Oxide Red1K09F3G675IACT

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Aluminum OxideALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
Aluminum OxideALUMINUM OXIDELMI26O6933SPONGE / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii+route
6 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Ferric Oxide RedFERRIC OXIDE RED1K09F3G675CREAM / TOPICALNAExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
ndc (product): 58892-326
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.468d6476-127a-e9f0-e063-6294a90a3df92025-12-22WarningsExact identifier
ndc (product): 58892-326
2a630d89-3a34-4a56-a494-ba02b7a833caa5d22c0f-c55b-4344-ba7f-1b40d3b7c5a32012-12-07WarningsExact identifier
spl id: 2a630d89-3a34-4a56-a494-ba02b7a833ca
spl set id: a5d22c0f-c55b-4344-ba7f-1b40d3b7c5a3