Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

Butyloctyl Salicylate Alkyl (c12-15) Benzoate Behenyl Acrylate Polymer 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 Isododecane Isohexadecane Methyl Methacrylate/glycol Dimethacrylate Crosspolymer Microcrystalline Cellulose Octyldodecyl Erucate Octyldodecyl Neopentanoate Polyhydroxystearic Acid (2300 Mw) Poly(methyl Methacrylate; 450000 Mw) Polysorbate 80 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

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.

Purpose:

Sunscreen

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
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:

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, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, 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

Non-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

Non-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)

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.

Purpose:

Sunscreen

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
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:

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, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, 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

Non-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

Non-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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450000 MW)", "unii": "Z47NNT4J11", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1,3,3,3-TETRAFLUOROPROPENE, (1E)-", "unii": "5I2481UOO8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRICONTANYL POVIDONE", "unii": "N0SS3Q238D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIETHOXYCAPRYLYLSILANE", "unii": "LDC331P08E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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": "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.", "Purpose:": "Sunscreen Sunscreen", "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 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:": "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, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, 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 Non-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 Non-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