Cotz Baby Cream
FDA Label NDC 58892-618

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 Baby (NDC 58892-618). 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 other, active ingredients:, purpose:, uses:, warnings:, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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DRUG FACTS

Active Ingredients:

Zinc Oxide 20%

Purpose:

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.

Otc - Do Not Use

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 40 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

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Microcrystalline Wax, PEG-10 Dimethicome, PEG-30 Dipoly-hydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexydecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

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 – Cotz Baby Tube Label

CoTZ®

the HEALTHIER
SUNSCREEN®

Baby

Non-Tinted

SPF
40

Soothing & Gentle

MINERAL SUNSCREEN

For 6+ Months

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – Cotz Baby Carton Label

CoTZ®

the HEALTHIER
SUNSCREEN®

Baby

Non-Tinted

SPF
40

Soothing & Gentle

MINERAL SUNSCREEN

For 6+ Months

Broad Spectrum SPF 40

Water Resistant (40 minutes)

Net Wt. 3.5 oz/100 g

* Please review the disclaimer below.