Otc - Active Ingredient
Active Ingredients
Non Nano Zinc Oxide 18%
Purpose
Sunscreen
Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted Spf 30 Cream
FDA Label NDC 72096-102
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kokua Sun Care for the product Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted Spf 30 (NDC 72096-102). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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
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 Center right away.
Indications & Usage
Stop use and ask a doctor if rash occurs
Warnings
Warnings
- for external use only
- Do not use on damaged skin
- When using this product keep out of eyes. Rinse with water to remove
Dosage & Administration
Directions
- Apply generously 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 SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10am - 2pm
- Wear long-sleeve shirts, pants, hats, and sunglasses
- Children under 6 months: ask a doctor
- Reapply
Inactive Ingredient
Water (Aqua), Aloe Barbadensis Leaf Juice, Coco-caprylate/Caprate, Glycerin, Macademia (Ternifolia) Seed Oil, Kukui Seed(Aleurites Moluccana) Oil, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Hydrogenated Methyl Abietate, Magnesium Sulfate, Galactoarabinan, Diheptyl Succinate, Capryloyl Glycerin/Sebacic Acid Copolymer, Propanediol, Polyglyceryl-2 Stearate, Caprylic/Capric Triglyceride, Noni (Morinda Citrifola) Fruit Extract, Spirulina (Arthrospira Platensis), Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Coffea Arabica (Coffee) Leaf/Seed Extract, Vanilla planifolia Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Cinnamomium Zeylanicum Bark Extract, Kaolin, Hydrogenated Vegetable Oil, Helianthus Annuus (Sunflower) Seed Oil, Plumeria Alba Flower Extract, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Sodium Levulinate, Sodium Anisate, Iron oxides
Package Label.Principal Display Panel
Kokua Sun Care
Tinted SPF 30
Hawaiian Natural Zinc Sunscreen Broad Spectrum SPF 30
80 Minutes
Water Resistant
89 ML/ 3 FL OZ
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