Cotz Spf 58
FDA Label NDC 58892-910

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 Spf 58 (NDC 58892-910). 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, indications & usage, warnings, dosage & administration, inactive ingredients, uva - same everyday, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS

Other Information Sun Alert: limiting sun expusure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. May stain some fabric.

Active Ingredients

Titanium Dioxide 10%

Zinc Oxide 3%

Purpose

Sunscreen

Sunscreen

Indications & Usage

Uses: Helps prevent sunburn

  • Retains SPF up to 40 minutes of water immersion or perspiring

Warnings

Warnings: For external use only

  • Avoid contact with eyes. In case of eye contact, flush eyes with water thoroughly
  • Do not use if sensitive to ingredients • Discontinue use if irritation occurs. Consult a doctor or healthcare professional if irritation persists
  • For use on children less than 6 months of age, consult a doctor.
  • Keep this and all medicines out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center

Dosage & Administration

Directions: Apply generously and uniformly to all exposed skin areas before exposure to sunlight

  • Continure to rub in until fading occurs, especially in hair bearing areas
  • Reapply as needed and after washing, swimming, towel drying, or sweating for maximum protection.

Inactive Ingredients

Acrylates C10-30 Alkyl

Acrylates Crosspolymer,

Butylene Glycol, Butyloctyl

Salicylate, Butylparaben,

Capric/Caprylic Triglyceride,

Cetearyl Alcohol, Cetearyl

Glucoside, Cyclomethicone,

Dimethicone, EDTA,

Ethylhexyl Hydroxystearate

Benzoate, Glyceryl Stearate,

Iron Oxides, Isobutylparaben,

Isopropylparaben,

Melissa Officinalis (Balm

Mint) Extract, Octyldodecyl

Neopentanoate, PEG-100

Stearate, Phenoxyethanol,

Retinyl Palmitate,

Simethicone, Sorbitan

Laurate, Styrene/Acrylates

Copolymer, Talc, Tocopherol,

Tocopheryl Acetate,

Tricontanyl PVP, Water,

Xanthan Gum

Uva - Same Everyday

UVA radiation, unlike UVB, is consistently the same all day long, all month long and all year long. UVA rays present almost the same damaging effects to the skin in December at 9 am, as they do in July at 4 pm. UVA radiation is consistently damaging, and in fact, enters deeper into the skin than UVB. Since UVA damage is cumulative and penetrates through glass, everyone requires daily, year round protection.

  • Extra gentle - no chemical sunscreen filters
  • Dries clear
  • Oil & PABA free
  • Fragrance free

    • Manufactured exclusively for:
    Fallien,     West Norriton, PA 19403
    www.totalblock.com

    Made in USA

Principal Display Panel

Principal Display Panel – Carton Label

NDC 58892-910-87

Dermatologist Recommended for Sensitive Skin

FALLENE CoTZ®

Contains Only Titanium & Zinc®

WATER-RESISTANT SUN PROTECTION

UVA-UVB SPF 58

Net Wt. 2.5 Oz./ 70 g

Figure (Cot00 0000 01)

Figure (Cot00 0000 01)

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