Eezysun Spf 50 Adults Cream
FDA Label NDC 70116-027

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bio Earth Manufacturing (pty) Ltd for the product Eezysun Spf 50 Adults (NDC 70116-027). 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 drug facts, active ingredients, purpose, uses, warnings, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Zink Oxide 10 % & Titanium Dioxide 8 %

Purpose

Sunscreen

Uses

  • helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer 

Warnings

  • For external use only.
  • Do not use: on damaged or broken skin.
  • When using this product: keep out of the eyes, rinse with water to remove.
  • Stop using this product if: Rash occurs

Keep Out Of Reach Of Children

Directions

  • Shake well before use.
  • Apply liberally 15 minutes before sun exposure

    • Reapply

    • after 80 minutes if swimming or sweating
    • immediately after towel drying
    • at least every two hours

      • Sun protection measures use a broad-spectrum sunscreen with an SPF value of 50 or higher

      • limit time in the sun, especially from 10am - 2pm
      • wear long-sleeve shirts, pants, hats, sunglasses
      • Children under 6 months of age: ask a doctor

Other Information

  • Store at or below 77⁰ F/25⁰C
  • Do not use if seal is broken
  • protect from excessive heat and direct sun

Inactive Ingredients

Aloe Vera, Aqua, Ascorbic Acid, Barium Sulphate, Cetearyl Alcohol, Citric Acid, Glycerine, Glyceryl Stearate, Hydroxyethyl Cellulose, Citrullus Vulgaris (Kalahari Melon) Oil, Potassium Cetyl Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis(Castor)Ceed Oil, Hydrogenated Castor Oil, Copernica Cerifera(Carnauba)Wax, Rosehip Fruit Oil, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Soybean Oil, Tocopherol, Vanilla Planifolia Fruit Oil

Product Label

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