SPL v2
SPL
SPL Set ID 885a674b-3457-4dfe-a801-529094b00499
Route
TOPICAL
Published
Effective Date 2025-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Alkyl (c12-15) Benzoate Caprylhydroxamic Acid Caprylyl Glycol Cetyl Peg/ppg-10/1 Dimethicone (hlb 5) Cyclomethicone 6 Cyclomethicone 5 Dimethicone 100 Dimethicone/diene Dimethicone Crosspolymer Edetate Disodium Methicone (20 Cst) Microcrystalline Wax Peg-10 Dimethicone (600 Cst) Peg-30 Dipolyhydroxystearate Polyglyceryl-4 Isostearate Polyhydroxystearic Acid (2300 Mw) Polysorbate 20 Sodium Chloride Stearyl Dimethicone (400 Mpa.s At 50c) Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Trolamine Triethoxycaprylylsilane Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2012-03-30

Description

Zinc Oxide 20%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20%

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

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

Purpose:

Sunscreen

Directions:
  • Apply liberally 15 minutes before sun exposure.

    Reapply:

    • -
      After 40 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:

Zinc Oxide 20%

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Principal Display Panel – Cotz Sensitive Tube Label

CoTZ®

the HEALTHIER

SUNSCREEN®

Sensitive

Non-Tinted

SPF

40

Gentle Zinc Oxide

MINERAL SUNSCREEN

FACE & BODY

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Cotz Sensitive Carton Label

CoTZ®

the HEALTHIER

SUNSCREEN®

Sensitive

Non-Tinted

SPF

40

Gentle Zinc Oxide

MINERAL SUNSCREEN

FACE & BODY

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 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.

Section 50570-1 (50570-1)

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

Purpose:

Sunscreen

Directions:
  • Apply liberally 15 minutes before sun exposure.

    Reapply:

    • -
      After 40 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:

Zinc Oxide 20%

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Principal Display Panel – Cotz Sensitive Tube Label (Principal Display Panel – CoTZ Sensitive Tube Label)

CoTZ®

the HEALTHIER

SUNSCREEN®

Sensitive

Non-Tinted

SPF

40

Gentle Zinc Oxide

MINERAL SUNSCREEN

FACE & BODY

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Cotz Sensitive Carton Label (Principal Display Panel – CoTZ Sensitive Carton Label)

CoTZ®

the HEALTHIER

SUNSCREEN®

Sensitive

Non-Tinted

SPF

40

Gentle Zinc Oxide

MINERAL SUNSCREEN

FACE & BODY

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)