SPL v2
SPL
SPL Set ID 479a7d82-a068-4c2e-b50b-555c40e13e37
Route
TOPICAL
Published
Effective Date 2021-05-01
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 2019-04-15

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.

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

Directions:

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.-2:00 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

Not tested on animals

Active Ingredients:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C 12- 15Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Principal Display Panel 4.5 G Carton Label

CoTZ ®

the HEALTHIER

SUNCREEN ®

Lip Balm

Lightly Tinted

100% Free of

Chemical Sunscreens,

Lanolin, Gluten

PROTECT & MOISTURIZE

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.

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

Directions:

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.-2:00 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

Not tested on animals

Active Ingredients:

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Asorbic Acid, Ascorbyl Palmitate, C 12- 15Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, 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)

CoTZ ®

the HEALTHIER

SUNCREEN ®

Lip Balm

Lightly Tinted

100% Free of

Chemical Sunscreens,

Lanolin, Gluten

PROTECT & MOISTURIZE

SPF 45 Broad Spectrum • Water Resistant (80 Minutes)

Net Wt. .14 oz/4.5 g


Advanced Ingredient Data


Raw Label Data

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