DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

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

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-07-30

Medication Information

Warnings and Precautions

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.

Indications and Usage

DIRECTIONS:

• Shake well before using.

• Press nozzle carefully during first use

• 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 am -2 pm

• Wear long-sleeved shirts, pants, hats, and sunglasses

Dosage and Administration

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.

Apply liberally 15 minutes befor sun exposure.

Description

ACTIVE INGREDIENTS: Titanium Dioxide 3% Zinc Oxide 10%

Section 50565-1

Keep out of the reach of children.

Section 51727-6

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 Erucate, Octyldodecyl

Neopentanoate, Polymethyl Methacrylate, Polysorbate 80,

Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane,

Trimethoxycaprylylsilane, Water

Section 51945-4

Principal Display Panel – 113 g Bottle Label

PROCEUTICALS

PRIVATE LABEL by TiZO

non-tinted

mineral sunscreen

20% zinc oxide

broad spectrum spf 40

water resistant (40 minutes)

net wt. 4 oz/ 113 g

Graphic-Untitled

Section 55105-1

PURPOSE:Sunscreen

USES: Helps prevent sunburn. If used as directed with other sun protection

measures (see Directions), decreases the risk of skin cancer and early aging

caused by the sun.

Section 55106-9

ACTIVE INGREDIENTS:

Titanium Dioxide 3%

Zinc Oxide 10%

Section 60561-8

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 temperatures above 120° F.

Structured Label Content

Indications and Usage (34067-9)

DIRECTIONS:

• Shake well before using.

• Press nozzle carefully during first use

• 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 am -2 pm

• Wear long-sleeved shirts, pants, hats, and sunglasses

Dosage and Administration (34068-7)

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.

Apply liberally 15 minutes befor sun exposure.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 51727-6 (51727-6)

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 Erucate, Octyldodecyl

Neopentanoate, Polymethyl Methacrylate, Polysorbate 80,

Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane,

Trimethoxycaprylylsilane, Water

Section 51945-4 (51945-4)

Principal Display Panel – 113 g Bottle Label

PROCEUTICALS

PRIVATE LABEL by TiZO

non-tinted

mineral sunscreen

20% zinc oxide

broad spectrum spf 40

water resistant (40 minutes)

net wt. 4 oz/ 113 g

Graphic-Untitled

Section 55105-1 (55105-1)

PURPOSE:Sunscreen

USES: Helps prevent sunburn. If used as directed with other sun protection

measures (see Directions), decreases the risk of skin cancer and early aging

caused by the sun.

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Titanium Dioxide 3%

Zinc Oxide 10%

Section 60561-8 (60561-8)

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 temperatures above 120° F.

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "DIRECTIONS: • Shake well before using. • Press nozzle carefully during first use • 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 am -2 pm • Wear long-sleeved shirts, pants, hats, and sunglasses", "34068-7": "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. Apply liberally 15 minutes befor sun exposure.", "34071-1": "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.", "50565-1": "Keep out of the reach of children.", "51727-6": "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 Erucate, Octyldodecyl Neopentanoate, Polymethyl Methacrylate, Polysorbate 80, Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Trimethoxycaprylylsilane, Water", "51945-4": "Principal Display Panel – 113 g Bottle Label PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen 20% zinc oxide broad spectrum spf 40 water resistant (40 minutes) net wt. 4 oz/ 113 g Graphic-Untitled", "55105-1": "PURPOSE:Sunscreen USES: Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.", "55106-9": "ACTIVE INGREDIENTS: Titanium Dioxide 3% Zinc Oxide 10%", "60561-8": "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 temperatures above 120° F."}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information