drug facts:

drug facts:
SPL v2
SPL
SPL Set ID 44a6ff9b-8067-4f32-acb2-4ede54c79e6e
Route
topical
Published
Effective Date 2022-08-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
titanium dioxide (40 mg) zinc oxide (55 mg)
Inactive Ingredients
aluminum oxide aluminum hydroxide aluminum stearate ascorbic acid ascorbyl palmitate alkyl (c12-15) benzoate cetearyl isononanoate cetyl peg/ppg-10/1 dimethicone (hlb 4) citric acid monohydrate dipropylene glycol caprylate ethylhexyl palmitate ethylene brassylate helianthus annuus seed wax hexyldecanol hexyl laurate ferric oxide red lecithin, sunflower ceresin polyethylene glycol 400 polyglyceryl-3 diisostearate polyhydroxystearic acid (2300 mw) stearic acid tocopherol .alpha.-tocopherol acetate ginger oil

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-04-01

Purpose

Sunscreen Sunscreen

Description

Titanium Dioxide 4.0% Zinc Oxide 5.5%


Medication Information

Purpose

Sunscreen

Sunscreen

Description

Titanium Dioxide 4.0% Zinc Oxide 5.5%

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 reach of children. If Swallowed, get medical help or contact a Poison Control Center right away.

Warnings:

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.

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
Active Ingredients

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

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

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Ethylene Brassylate, Helianthus Annuus (Sunflower), Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

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 10am-2pm
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Principal Display Panel – Carton Label

CoTZ®

the HEALTHIER SUNSCREEN®

Mineral Sun Stick

Tinted

SPF

45

SHEER

MINERAL SUNSCREEN

FACE & BODY

SPF 45 Broad Spectrum

Water Resistant (80 Minutes)

Net Wt. 1 oz./30 g.


Structured Label Content

Purpose

Sunscreen

Sunscreen

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 reach of children. If Swallowed, get medical help or contact a Poison Control Center right away.

Warnings:

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.

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
Active Ingredients

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

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

Inactive Ingredients:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Acid, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Acid, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Ethylene Brassylate, Helianthus Annuus (Sunflower), Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Sun Protection Measures: (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 10am-2pm
  • Wear long-sleeved shirts, pants, hats, and sunglasses
Principal Display Panel – Carton Label

CoTZ®

the HEALTHIER SUNSCREEN®

Mineral Sun Stick

Tinted

SPF

45

SHEER

MINERAL SUNSCREEN

FACE & BODY

SPF 45 Broad Spectrum

Water Resistant (80 Minutes)

Net Wt. 1 oz./30 g.


Advanced Ingredient Data


Raw Label Data

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