Cotz Pure Spf 30
FDA Label NDC 58892-600

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 Pure Spf 30 (NDC 58892-600). 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.

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DRUG FACTS

Active Ingredients:

Titanium Dioxide 4.1%

Zinc Oxide 8.4%

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.

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 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:

Brassica Campestris/Aleurites Fordii Oil Copolymer1 (from rapeseed and aleurites oils), Butyrospermum Parkii (Shea) Butter1 (shea tree extract), Camellia Oleifera Leaf Extract1 (Japanese green tea), Capric/Caprylic Triglyceride1,2,3(from coconut), Cellulose Gum1(from plant), Cetearyl Alcohol1,2,3(from coconut/ palm), Cetearyl Glucoside1,2,3(from coconut/palm and glucose sugar), Citric Acid (from citrus fruit), Glyceryl Caprylate1,2(from coconut), Glyceryl Undecylenate1,2(from castor bean and coconut glycerin), Iron Oxide1 (CI 77491) (natural mineral), Melissa Officinalis (Balm Mint) Extract1 (natural herb), Microcrystalline Cellulose1 (from wood pulp), Polyhydroxystearic Acid2(from castor plant), Rosmarinus Officinalis (Rosemary) Extract1 (natural herb), Salvia Officinalis (Sage) Leaf Extract1 (natural herb), Simmondsia Chinensis (Jojoba) Esters1,2(from natural plant) Sodium Stearoyl Glutamate1,2,3(from coconut and amino acid), Sorbitan Oleate Decylglucoside Crosspolymer4(from sugar and plant derived oleic acid), Xanthan Gum1(from plant sugar), Water

Other Information:

  • - Protect this product from excessive heat and direct sun
  • - May stain some fabrics

    • * All ingredients approved by one or more of these leading organizations: 1. Natural Products Association, 2. EcoCert, 3 NSF International, 4. Green Star Rated

Principal Display Panel – Spf 30 85G Carton Label

DERMATOLOGIST RECOMMENDED

CoTZ®

PURE

The Healthier Sunscreen
0%
Synthetic Ingredients
Preservatives
Chemical Sunscreens

Balanced Mineral ComplexTM Helps Prevent
Heat Build-Up in Skin, which Can
Damage the Dermis

Broad
Spectrum
SPF 30

Silky Soft & Gentle
Water Resistant
(40 minutes)

Net Wt. 3.5 oz/85.0 g

Principal Display Panel – Spf 30 85g Carton Label (Cot05 0000 01)

Principal Display Panel – Spf 30 85g Carton Label (Cot05 0000 01)

* Please review the disclaimer below.