Cotz Mineral Suns Stick - Tinted Spf 45 Stick
FDA Label NDC 58892-349

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fallien Cosmeceuticals, Ltd for the product Cotz Mineral Suns Stick - Tinted Spf 45 (NDC 58892-349). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses:, warnings:, otc - keep out of reach of children, directions:, sun protection measures:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

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.

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.

Otc - Keep Out Of Reach Of Children

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

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

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

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

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

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.

Principal Display Panel – Carton Label (Cot0r 0000 01)

Principal Display Panel – Carton Label (Cot0r 0000 01)

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