SPL v1
SPL
SPL Set ID a9de01a9-9b33-4f0e-ac99-0484f3d9fb9e
Route
TOPICAL
Published
Effective Date 2012-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Alkyl (c12-15) Benzoate Caprylhydroxamic Acid Caprylyl Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Cyclomethicone 6 Cyclomethicone 5 Dimethicone 100 Dimethicone/diene Dimethicone Crosspolymer Edetate Disodium Methicone (20 Cst) Microcrystalline Wax Peg-10 Dimethicone (600 Cst) Peg-30 Dipolyhydroxystearate 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2012-09-02
Description

DRUG FACTS

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

DRUG FACTS

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.

Section 42229-5

DRUG FACTS

Section 50565-1

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product, keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Warnings:

For external use only.

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 10:00 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Active Ingredients:

Zinc Oxide 20%

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Manufactured exclusively for

Fallien, Ltd.

West Norriton PA 19403

Made in USA

Principal Display Panel – Spf 35 100g Carton Label

NDC 58892-318-01

SOLAR

PROTECTION

FORMULA ®

TiZO ®

For Ultra

Sensitive Skin

20% Zinc Oxide

Pure Mineral Protection

SPF 35

Broad Spectrum

Water Resistant

(40 minutes)

Net Wt. 3.5 Oz./ 100g

Structured Label Content

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.

Section 42229-5 (42229-5)

DRUG FACTS

Section 50565-1 (50565-1)

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product, keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose

Sunscreen

Warnings:

For external use only.

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 10:00 a.m.-2 p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Active Ingredients:

Zinc Oxide 20%

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Manufactured exclusively for

Fallien, Ltd.

West Norriton PA 19403

Made in USA

Principal Display Panel – Spf 35 100g Carton Label (Principal Display Panel – SPF 35 100g Carton Label)

NDC 58892-318-01

SOLAR

PROTECTION

FORMULA ®

TiZO ®

For Ultra

Sensitive Skin

20% Zinc Oxide

Pure Mineral Protection

SPF 35

Broad Spectrum

Water Resistant

(40 minutes)

Net Wt. 3.5 Oz./ 100g

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:34.228607 · Updated: 2026-03-14T22:53:21.930902