Sunscreen
FDA Label NDC 29565-200

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Uv Natural International Pty Ltd for the product Sunscreen (NDC 29565-200). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, 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.

Label Section Quick Index

Otc - Active Ingredient

Zinc oxide 24.8%

Otc - Purpose

Sunscreen

Indications & Usage

Uses

  • Helps prevent 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

Otc - Do Not Use

Do not use on damaged or broken skin. 

Otc - When Using

When using this product keep out of eyes.  Rinse with water to remove.

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 product is swallowed, get medical help or contact a Poison Control Centre right away.

Dosage & Administration

Directions

  • apply liberally 15 minutes before sun exposure
  • re-apply after 40 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two 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 of 15 or higher and other sun protection measures including:

    • limit time in sun, especially from 10am-2pm
    • wear long sleeve shirts, pants, hats and sunglasses
      • Children under 6 months ask your doctor.

Storage And Handling

protect this product from excessive heat and direct sun

Inactive Ingredient

Vitis vinifera (grape) seed oil, Caprilic/capric triglycerides, Slica, Zinc stearate, Macadami ternifolia seed oil, Camellia oleifera leaf extract (green tea), Vitis vinifera (grape) seed extract, Tocopherol, Iron oxides

Package Label.Principal Display Panel


  • No Added Fragrance
  • Natures Finest Oils
  • Preservative Free
  • Non Greasy
  • Moisturizing
  • Grapeseed
  • Green Tea
    • Spf30 Label (Spf30)

    Spf30 Label (Spf30)



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