Cotz Face Prime And Protect Spf 40 (tinted) Cream
FDA Label NDC 58892-354

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 Face Prime And Protect Spf 40 (tinted) (NDC 58892-354). 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 - stop use, otc - when using, otc - keep out of reach of children, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Titanium Dioxide 8%

Zinc Oxide 3.8%

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.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - When Using

When using this product, keep out of eyes. Rinse with water to remove.

Otc - Keep Out Of Reach Of Children

Keep out of the 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 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

Principal Display Panel - 42.5 G Carton Label

CoTZ®
the HEALTHIER
SUNCREEN®

Face

Prime & Protect

Tinted

SPF
40

Sheer Matte

MINERAL SUNSCREEN

PA +++

FACIAL PRIMER

Broad Spectrum SPF 40

Water Resistant (80 Minutes)

Net Wt. 1.5 oz/42.5 g

Principal Display Panel (42.5 g Carton Label)

Principal Display Panel (42.5 g Carton Label)

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