drug facts

Composition & Product

Active Ingredients

titanium dioxide (80 mg) zinc oxide (38 mg)

Inactive Ingredients

aluminum hydroxide cyclomethicone 6 cyclomethicone 5 dimethicone 20 dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) dimethicone/vinyl dimethicone crosspolymer (soft particle) dimethiconol (2000 cst) ferric oxide red lauryl peg/ppg-18/18 methicone hydrogen dimethicone (20 cst) peg-10 dimethicone (600 cst) tetrahexyldecyl ascorbate .alpha.-tocopherol acetate

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2024-06-04

Medication Information

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

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.

Purpose:

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 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 am-2 pm
Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information:

Protect this product from excessive heat and direct sun
May stain some fabrics
PA +++

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Principal Display Panel – 53 G Bottle Label

PROCEUTICALS

PRIVATE LABEL by TiZO

tinted

mineral sunscreen

broad spectrum spf 40

water resistant (80 minutes)

net wt. 1.8 oz / 53 g

Structured Label Content

Uses: (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: (PURPOSE:)

Sunscreen

Warnings: (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: (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 am-2 pm
Wear long-sleeved shirts, pants, hats, and sunglasses

Other Information: (OTHER INFORMATION:)

Protect this product from excessive heat and direct sun
May stain some fabrics
PA +++

Active Ingredients: (ACTIVE INGREDIENTS:)

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Principal Display Panel – 53 G Bottle Label (Principal Display Panel – 53 g Bottle Label)

PROCEUTICALS

PRIVATE LABEL by TiZO

tinted

mineral sunscreen

broad spectrum spf 40

water resistant (80 minutes)

net wt. 1.8 oz / 53 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": "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 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 am-2 pm Wear long-sleeved shirts, pants, hats, and sunglasses", "OTHER INFORMATION:": "Protect this product from excessive heat and direct sun May stain some fabrics PA +++", "ACTIVE INGREDIENTS:": "Titanium Dioxide 8% Zinc Oxide 3.8%", "INACTIVE INGREDIENTS:": "Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate", "Principal Display Panel – 53 g Bottle Label": "PRO CEUTICALS PRIVATE LABEL by TiZO tinted mineral sunscreen broad spectrum spf 40 water resistant (80 minutes) net wt. 1.8 oz / 53 g"}