Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f106f52b-2157-46c7-9f7c-50f43a649050
Route
TOPICAL
Published
Effective Date 2021-06-16
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) Lauryl Peg/ppg-18/18 Methicone Hydrogen Dimethicone (20 Cst) Peg-10 Dimethicone (600 Cst)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-11-15

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

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.

Purpose:

Sunscreen

Sunscreen

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%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone. Dimethicone Crosspolymer. Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18-Hydrogen Dimethicone, Hydrogen Dimethicone, PEG-10 Dimethicone

Principal Display Panel – 42.5 G Carton Label

CoTZ ®

the HEALTHIER

SUNSCREEN®

Face

Prime & Protect

Non-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)

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.

Purpose:

Sunscreen

Sunscreen

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%

Inactive Ingredients:

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone. Dimethicone Crosspolymer. Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Lauryl PEG/PPG-18/18-Hydrogen Dimethicone, Hydrogen Dimethicone, PEG-10 Dimethicone

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

CoTZ ®

the HEALTHIER

SUNSCREEN®

Face

Prime & Protect

Non-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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