Eezysun Spf 50 Cream
FDA Label NDC 70116-014

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 (NDC 70116-014). 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 purpose, uses, warnings, direction, other information, inactive ingredients, active ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Purpose

Sunscreen

Uses

Helps prevent sunburn and protects against insects
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 eyes ,rinse with water to remove
    • Stop use and ask doctor if rash occurs
    • Keep out of reach of children

Direction

  • Apply liberally 15 minutes before sun exposure. Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun protection measures. Use a broad spectrum sun-screen with an SPF value of 50 or higher
  • limit time in the sun, especially from 10 am - 2 pm
  • wear long-sleeve shirts, pants, hats and sunglasses
  • Children under 6 months of age: ask a doctor

Other Information

store at or below 77° F . Do not use if seal is broken

Inactive Ingredients

Aloe Barbadensis Leaf Oil, Aqua, Ascorbic Acid, Baryte,Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citronella,Citrullus Vulgaris (Kalahari Melon) Oil, Glycerine, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Hydroxyethyl Cellulose,Lemongrass, Neem, Polysorbate 20, Potassium Cetyl
Phosphate, Potassium Sorbate, Retinol Palmitate, Ricinus Communis (Castor) Seed Oil (and) Hydrogenated Castor Oil (and) Copernicia Cerifera (Carnauba) Wax, Rosa Mosqueta (Rosehip) Fruit, Sodium Benzoate, Sodium Lactate, Sorbitan Olivate, Tocopheryl Acetate, Vanilla Planifolia Fruit Oil

Active Ingredients

Zinc Oxide 10%, Titanium Dioxide 8%

Product Label

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Image Description (Product Label)

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