Eezysun Spf50 Babies And Kids
FDA Label NDC 70116-013

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 Spf50 Babies And Kids (NDC 70116-013). 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, direction, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Titanium Dioxide 3.5%, Zinc Oxide 9.5%

Purpose

Topical SPF50 Sun Cream for the prevention of sun burn

Uses

Helps prevents sunburn
if used as directed with other sun protection measures ( see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 40 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 77℉. Do not use if seal is broken
Protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Aloe Vera, Ascorbic Acid, Barium Sulphate, Bulbinella, Carnauba, Castor Seed Oil, Cetearyl Alcohol, Chamomile Oil, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hydrogenated Castor Oil, Hydroxyethyl Cellulose, Phenoxyethanol, Rosehip, Soybean Oil, Tocopheryl Acetate, Water, Xanthan Gum

Product Label

Image Description (Image 002)

Image Description (Image 002)

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