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) Brown Iron Oxide 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 2022-01-22

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.

Section 50566-9

Stop use and ask a doctor if rash occurs.

Section 50567-7

When using this product, keep out of eyes. Rinse with water to remove.

Section 50570-1

Do not use on damaged or broken skin.

Purpose:

Sunscreen

Warnings:

For external use only.

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+ + +

Manufactured for

PRIIA^® Cosmetics,

Bethlehem PA 18020

PRIIA.com

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Principal Display Panel – 53g Bottle Label

PRIIA ^®

minerale-derm

Tinted Mineral

Sunscreen + Primer

SPF 40

Broad Spectrum

Water Resistant

(80 Minutes)

Acne-Safe

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.

Section 50566-9 (50566-9)

Stop use and ask a doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product, keep out of eyes. Rinse with water to remove.

Section 50570-1 (50570-1)

Do not use on damaged or broken skin.

Purpose: (PURPOSE:)

Sunscreen

Warnings: (WARNINGS:)

For external use only.

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+ + +

Manufactured for

PRIIA^® Cosmetics,

Bethlehem PA 18020

PRIIA.com

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 (CI77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

Principal Display Panel – 53g Bottle Label

PRIIA ^®

minerale-derm

Tinted Mineral

Sunscreen + Primer

SPF 40

Broad Spectrum

Water Resistant

(80 Minutes)

Acne-Safe

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.", "50566-9": "Stop use and ask a doctor if rash occurs.", "50567-7": "When using this product, keep out of eyes. Rinse with water to remove.", "50570-1": "Do not use on damaged or broken skin.", "PURPOSE:": "Sunscreen Sunscreen", "WARNINGS:": "For external use only.", "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+ + + Manufactured for PRIIA ® Cosmetics, Bethlehem PA 18020 PRIIA.com", "ACTIVE INGREDIENTS:": "Titanium Dioxide 8% Zinc Oxide 3.8%", "INACTIVE INGREDIENTS:": "Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate", "Principal Display Panel – 53g Bottle Label": "PRIIA ® minerale-derm Tinted Mineral Sunscreen + Primer SPF 40 Broad Spectrum Water Resistant (80 Minutes) Acne-Safe Net Wt. 1.8 oz/53 g"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information