Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID db682516-6c8f-4009-a9ec-e21dfc64ce15
Route
TOPICAL
Published
Effective Date 2019-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (160 mg)
Inactive Ingredients
Medium-chain Triglycerides Ceramide Np 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 Hydrogen Dimethicone (20 Cst) Peg-10 Dimethicone (600 Cst) Polyhydroxystearic Acid (2300 Mw) Vinyl Dimethicone/methicone Silsesquioxane Crosspolymer

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-04
Description

Zinc Oxide 16%

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 16%

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

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:

Zinc Oxide 16%

Inactive Ingredients:

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Principal Display Panel – Tube Label

CoTZ ®

the HEALTHIER SUNSCREEN ®

Face

Moisture

Lightly Tinted

SPF

35

Hydrate & Protect

MINERAL SUNCREEN

FACE

Broad Spectrum SPF 35

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 g

Principal Display Panel – Carton Label

CoTZ ®

the HEALTHIER SUNSCREEN ®

Face

Moisture

Lightly Tinted

SPF

35

Hydrate & Protect

MINERAL SUNCREEN

FACE

Broad Spectrum SPF 35

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

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:

Zinc Oxide 16%

Inactive Ingredients:

Capric/Caprylic Triglyceride, Ceramide 3, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer

Principal Display Panel – Tube Label

CoTZ ®

the HEALTHIER SUNSCREEN ®

Face

Moisture

Lightly Tinted

SPF

35

Hydrate & Protect

MINERAL SUNCREEN

FACE

Broad Spectrum SPF 35

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 g

Principal Display Panel – Carton Label

CoTZ ®

the HEALTHIER SUNSCREEN ®

Face

Moisture

Lightly Tinted

SPF

35

Hydrate & Protect

MINERAL SUNCREEN

FACE

Broad Spectrum SPF 35

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 g

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.280916 · Updated: 2026-03-14T23:06:57.309434