Drug Facts

Composition & Product

Active Ingredients

Titanium Dioxide (30 mg) Zinc Oxide (100 mg)

Inactive Ingredients

Behenyl Acrylate Polymer Bismuth Oxychloride Butyloctyl Salicylate Alkyl (c12-15) Benzoate Caprylhydroxamic Acid Caprylyl Glycol Carboxymethylcellulose Sodium, Unspecified Form Polyoxyl 20 Cetostearyl Ether Cetostearyl Alcohol Citric Acid Monohydrate Edetate Disodium Anhydrous Glycereth-26 Glycerin Glyceryl Monostearate Ferric Oxide Red Ferric Oxide Yellow Ferrosoferric Oxide Isododecane Isohexadecane Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Mica Microcrystalline Cellulose Octyldodecyl Neopentanoate Polyhydroxystearic Acid (2300 Mw) Poly(methyl Methacrylate; 450000 Mw) Polysorbate 80 Octyldodecyl Erucate 1,3,3,3-tetrafluoropropene, (1e)- Tricontanyl Povidone Triethoxycaprylylsilane Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2016-11-29

Medication Information

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 3% Zinc Oxide 10%

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

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.

Purpose:

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.

Directions:

Shake well before using.
Use caution during 1^st application to reduce splatter.
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 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
Store between 68° to 104°F (20° to 40° C)
DO not store at temperature above 120° F

Manufactured Exclusively For:

CoTZ^® Skincare

Norristown, PA 19403

www.cotzskincare.com

Active Ingredients:

Titanium Dioxide 3%

Zinc Oxide 10%

Inactive Ingredients:

Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Ecruate, Octyldodecyl Neopentanoate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Polysorbate 80, Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

Principal Display Panel – Can Label

CoTZ ^®

the HEALTHIER SUNSCREEN®

Silky

Foam

Tinted

SPF

30

Foaming

MINERAL SUNSCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Carton Label

CoTZ ^®

the HEALTHIER SUNSCREEN ^®

Silky

Foam

Tinted

SPF

30

Vanishing Zinc Oxide

MINERAL SUNCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 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)

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.

Purpose:

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs.

Directions:

Shake well before using.
Use caution during 1^st application to reduce splatter.
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 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
Store between 68° to 104°F (20° to 40° C)
DO not store at temperature above 120° F

Manufactured Exclusively For:

CoTZ^® Skincare

Norristown, PA 19403

www.cotzskincare.com

Active Ingredients:

Titanium Dioxide 3%

Zinc Oxide 10%

Inactive Ingredients:

Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Ecruate, Octyldodecyl Neopentanoate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Polysorbate 80, Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

Principal Display Panel – Can Label

CoTZ ^®

the HEALTHIER SUNSCREEN®

Silky

Foam

Tinted

SPF

30

Foaming

MINERAL SUNSCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Carton Label

CoTZ ^®

the HEALTHIER SUNSCREEN ^®

Silky

Foam

Tinted

SPF

30

Vanishing Zinc Oxide

MINERAL SUNCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 g

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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.", "50565-1": "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.", "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.", "Directions:": "Shake well before using. Use caution during 1 st application to reduce splatter. 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 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 Store between 68° to 104°F (20° to 40° C) DO not store at temperature above 120° F Manufactured Exclusively For: CoTZ ® Skincare Norristown, PA 19403 www.cotzskincare.com", "Active Ingredients:": "Titanium Dioxide 3% Zinc Oxide 10%", "Inactive Ingredients:": "Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Ecruate, Octyldodecyl Neopentanoate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Polysorbate 80, Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water", "Principal Display Panel – Can Label": "CoTZ ® the HEALTHIER SUNSCREEN ® Silky Foam Tinted SPF 30 Foaming MINERAL SUNSCREEN BODY Broad Spectrum SPF 30 Water Resistant (40 Minutes) Net Wt. 3.5 oz/100 g", "Principal Display Panel – Carton Label": "CoTZ ® the HEALTHIER SUNSCREEN ® Silky Foam Tinted SPF 30 Vanishing Zinc Oxide MINERAL SUNCREEN BODY Broad Spectrum SPF 30 Water Resistant (40 Minutes) Net Wt. 3.5 oz/100 g"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information