Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Titanium Dioxide (40 mg) Zinc Oxide (55 mg)
Inactive Ingredients
Aluminum Oxide Aluminum Hydroxide Aluminum Stearate Ascorbic Acid Ascorbyl Palmitate Alkyl (c12-15) Benzoate Cetearyl Isononanoate Cetyl Peg/ppg-10/1 Dimethicone (hlb 4) Citric Acid Monohydrate Dipropylene Glycol Caprylate Ethylhexyl Palmitate Citrus Aurantiifolia Fruit Oil Kiwi Fruit Oil Helianthus Annuus Seed Wax Hexyldecanol Hexyl Laurate Ferric Oxide Red Lecithin, Sunflower Ceresin Polyethylene Glycol 400 Polyglyceryl-3 Diisostearate Polyhydroxystearic Acid (2300 Mw) Stearic Acid Tocopherol .alpha.-tocopherol Acetate Ginger Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-01
Description

Titanium Dioxide 4.0% Zinc Oxide 5.5%

Purpose

Sunscreen Sunscreen

Medication Information

Purpose

Sunscreen

Sunscreen

Description

Titanium Dioxide 4.0% Zinc Oxide 5.5%

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 50565-1

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

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.

Directions:

Apply liberally 15 mintues before sun exposure.

  • Reapply:
  • After 80 mintues 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 am-2:00 pm
    • -
      Wear long-sleeved shirts, pants, hats, and sunglasses
Active Ingredients

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, PolygIyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicapryte, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Principal Display Panel – 4.5 G Carton Label

TIZO ®

TINTED LIP PROTECTION

MINERAL SUNSCREEN

SPF

45

SPF 45 Broad Spectrum

Water Resistant (80 minutes)

Net Wt. .14 oz./4.5 g.

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 50565-1 (50565-1)

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

Purpose

Sunscreen

Sunscreen

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.

Directions:

Apply liberally 15 mintues before sun exposure.

  • Reapply:
  • After 80 mintues 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 am-2:00 pm
    • -
      Wear long-sleeved shirts, pants, hats, and sunglasses
Active Ingredients

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Other Information:
  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, PolygIyceryl-3 Diisostearate, Polyhydroxystearic Acid, Propylene Glycol Dicaprylate/Dicapryte, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Principal Display Panel – 4.5 G Carton Label (Principal Display Panel – 4.5 g Carton Label)

TIZO ®

TINTED LIP PROTECTION

MINERAL SUNSCREEN

SPF

45

SPF 45 Broad Spectrum

Water Resistant (80 minutes)

Net Wt. .14 oz./4.5 g.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:18.486513 · Updated: 2026-03-14T23:06:55.199519