drug facts

drug facts
SPL v2
SPL
SPL Set ID b2addf27-9139-48b4-85e6-618f4b5311cc
Route
topical
Published
Effective Date 2023-02-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

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

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 8% Zinc Oxide 3.8%


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

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 – 85g Bottle Label

PRIIA ®

minerale-derm

Tinted Mineral

Sunscreen + Primer

SPF 40

Broad Spectrum

Water Resistant

(80 Minutes)

Acne-Safe

Net Wt. 3 oz/85 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

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 – 85g Bottle Label

PRIIA ®

minerale-derm

Tinted Mineral

Sunscreen + Primer

SPF 40

Broad Spectrum

Water Resistant

(80 Minutes)

Acne-Safe

Net Wt. 3 oz/85 g


Advanced Ingredient Data


Raw Label Data

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