Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 1088fbf6-5790-490d-b272-ec281b4b76fa
Route
TOPICAL
Published
Effective Date 2021-05-21
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 Oxide 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)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-06-26

Description

Titanium Dioxide 8% Zinc Oxide 3.8%

Purpose

Sunscreen Sunscreen


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.

Purpose:

Sunscreen

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken skin.

Directions:
  • Apply liberally 15 minutes before sun exposure.

Reapply:

  • -
    After 80 minutes of swimming or sweating
  • -
    Immediately after towel drying
  • -
    At least every two 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.
  • May stain some fabrics.

Manufactured Exclusively For:

CoTZ® Skincare

Norristown. PA 19403

www.cotzskincare.com

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Principal Display Panel 42.5 G Carton Label

CoTZ ®

the HEALTHIER

SUNCREEN®

Face

Prime & Protect

Tinted

SPF

40

Sheer Matte

MINERAL SUNSCREEN

PA +++

FACIAL PRIMER

Broad Spectrum SPF 40

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 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)

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.

Purpose:

Sunscreen

Sunscreen

Warnings:

For external use only. Do not use on damaged or broken skin.

Directions:
  • Apply liberally 15 minutes before sun exposure.

Reapply:

  • -
    After 80 minutes of swimming or sweating
  • -
    Immediately after towel drying
  • -
    At least every two 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.
  • May stain some fabrics.

Manufactured Exclusively For:

CoTZ® Skincare

Norristown. PA 19403

www.cotzskincare.com

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

Principal Display Panel 42.5 G Carton Label (Principal Display Panel - 42.5 g Carton Label)

CoTZ ®

the HEALTHIER

SUNCREEN®

Face

Prime & Protect

Tinted

SPF

40

Sheer Matte

MINERAL SUNSCREEN

PA +++

FACIAL PRIMER

Broad Spectrum SPF 40

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 g


Advanced Ingredient Data


Raw Label Data

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