Cotz Spf 35
FDA Label NDC 58892-118

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 35 (NDC 58892-118). 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, directions, inactive ingredients:, principal display panel – 3.5oz carton label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Zinc Oxide 20%.

Purpose

Sunscreen

Uses

  • Helps prevent sunburn
  • Provides protection from UVA & UVB rays that may contribute to premature aging of the skin
  • Retains SPF up to 40 minutes of water immersion or perspiring

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 medications out of the reach of children
  • If swallowed, get medical help or contact a Poison Control Center

Directions

  • Apply generously and uniformly to all exposed skin areas before exposure to sunlight
  • Continue 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.

    • Other Information

    • Sun Alert: Limiting sun exposure, 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 fabrics

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG 10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/VinyI Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane,

Manufactured
exclusively for
Fallene, Ltd.
West Norriton, PA 19403
Made in USA

Principal Display Panel – 3.5Oz Carton Label

NDC 58892-118-01

Dermatologist

Recommended for

Ultra Sensitive Skin

CoTZ®

20% Zinc Oxide

vanishing formula

Pure Mineral

Sun protection

Moisturizing

water resistant

uva/uvb

SPF 35

Net. Wt. 3.5 oz./ 100g

Figure (Cot02 0000 01)

Figure (Cot02 0000 01)

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