Cotz Silky Foam - Tinted Aerosol, Foam
FDA Label NDC 58892-430

10 label sections · Submitted to the FDA by Fallien Cosmeceuticals, Ltd · 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 Silky Foam - Tinted (NDC 58892-430). 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:, inactive ingredients:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Titanium Dioxide 3%

Zinc Oxide 10%

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.

Otc - Keep Out Of Reach Of Children

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.

Directions:

  • Shake well before using.
  • Use caution during 1st application to reduce splatter.
  • Apply liberally 15 minutes before sun exposure.
  • Reapply:
    • After 40 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 10 a.m.-2 p.m.
      • Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients:

Bismuth Oxychloride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Disodium EDTA, Glycereth-26, Glycerin, Glyceryl Stearate, Iron Oxides, Isododecane, Isohexadecane, Methyl Methacrylate Crosspolymer, Mica, Microcrystalline Cellulose, Octyldodecyl Ecruate, Octyldodecyl Neopentanoate, Poly C10-30 Alkyl Acrylate, Polyhydroxystearic Acid, Polysorbate 80, Trans-1,3,3,3-Tetrafluoropropene, Triacontanyl PVP, Triethoxycaprylylsilane, Water

Other Information:

  • Protect this product from excessive heat and direct sun
  • May stain some fabrics
  • Store between 68° to 104°F (20° to 40° C)
  • DO not store at temperature above 120° F

    • Manufactured Exclusively For:
    CoTZ® Skincare
    Norristown, PA 19403
    www.cotzskincare.com

Principal Display Panel – Carton Label

CoTZ®
the HEALTHIER SUNSCREEN®

Silky
Foam

Tinted

SPF
30

Vanishing Zinc Oxide
MINERAL SUNCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Carton Label (Cot0g 0003 01)

Principal Display Panel – Carton Label (Cot0g 0003 01)

Principal Display Panel – Can Label

CoTZ®
the HEALTHIER SUNSCREEN®

Silky
Foam

Tinted

SPF
30

Foaming
MINERAL SUNSCREEN

BODY

Broad Spectrum SPF 30

Water Resistant (40 Minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Can Label (Cot0g 0003 02)

Principal Display Panel – Can Label (Cot0g 0003 02)

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