Hawaiian Sol Natural Sunscreen Spf-30 Solution
FDA Label NDC 82520-263

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Caribbean Sol International, Llc for the product Hawaiian Sol Natural Sunscreen Spf-30 (NDC 82520-263). 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 ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor, 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

Active Ingredient

Zinc Oxide 16%

Purpose

Sunscreen

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

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 A Doctor

if rash ocuurs

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Directions-------Shake Well--------

  • 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 - 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 SPE 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-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients:

Adansonia Digitata (Baobab) Oil, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecane, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Hydroxyethylcellu-lose, Laminaria (Algae) Extract, Mangifera Indica (Mango) Butter, Polyhydroxystearic Acid, Punica Granatum (Pomegranate) Extract, Tocopherol (Vitamin E), Tridecyl Salicylate, Xanthan Gum.

Other Information

protect this product from excessive heat and direct sun

Claims:

  • Mineral Ingredients
  • No Animal Testing
  • Gluten Free
  • No Parabens

Package Labeling:

Label (Label)

Label (Label)

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