Itk Broad Spectrum Spf 50 Sunscreen Serum
FDA Label NDC 71899-066

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Maesa, Llc. for the product Itk Broad Spectrum Spf 50 Sunscreen Serum (NDC 71899-066). 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 - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts:

Dist. by Maesa LLC,
New York, NY 10281

Active Ingredients

Zinc Oxide 24.5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.

Warnings

  • For external use only.

Otc - Do Not Use

  • Do not use on damaged or broken skin.
  • Do not use in eye area. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Pump serum onto clean hands and work into a clean, dry face.
  • Do not use in eye area.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours.
  • 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

Water (Aqua/Eau), Coco-Caprylate, Glyceryl Oleate Citrate, PEG-8 Stearate, Glyceryl Stearate, Tocopheryl Acetate, Polysorbate 20, Polyhydroxystearic Acid, Panthenol, Benzyl Alcohol, Cetearyl Alcohol, Triethoxycaprylylsilane, Caprylic/Capric Triglyceride, Xanthan Gum, Sorbitan Oleate, Lauroyl Lysine, Sodium Phytate, Dehydroacetic Acid, Carnosine.

Other Information

  • Protect this product in this container from excessive heat and direct sun.

Questions, Comments

YOU MAY REPORT AN ADVERSE REACTION TO: ITK C/O REPORT REACTION LLC, PO BOX 22, PLAINSBORO, NJ 08536-0222.

Principal Display Panel - 60 Ml Tube Carton

itk

SCAN ME

BROAD SPECTRUM
SPF 50 SUNSCREEN
SERUM

hydrates +
UVA/UVB protection +
blue light protection

2 FL. OZ. / 60 mL

Principal Display Panel (60 mL Tube Carton)

Principal Display Panel (60 mL Tube Carton)

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