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| Product NDC Code | 72096-101 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Hawaiian natural zinc sunscreen spf 50 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | part352 | ||||||
| Labeler Name | Kokua Sun Care | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Zinc Oxide 25% Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions Apply generously 15 minutes before sun exposure Reapply: After 80 minutes if 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 10 am-2pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua), Aloe Barbadensis Leaf Juice, Caprylyl Caprylate/Caprate, Macadamia Ternifolia Seed (Macadamia Nut) Oil, Aleurites Moluccana Seed (Kukui nut) oil, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, Glycerin, Cocos Nucifera (Coconut) Oil, Cetyl Dimethicone, Magnesium Sulfate, Hydrogenated Methyl Abietate, Galactoarabinan, Propanediol, Polyglyceryl-2 Stearate, KonaRed Hawaiian Coffee Fruit Extract, Morinda Citrifolia Fruit Juice (Noni), Arthrospira Platensis (Hawaiian Spirulina), Oryza Sativa (Rice) Bran Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Extract, Caprylic/Capric Triglyceride, Prunus Armeniaca (Apricot) Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Santalum Album (Sandalwood) Extract, Butter Extract, Coffea Arabica (Coffee) Leaf/seed Extract, Pyrus Malus (Apple) Fruit Extract, Cocos Nucifera (Coconut) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Plumeria Alba Flower Extract, Kaolin, Hydrogenated Vegetable Oil, 1,2-Hexanediol, Caprylhydroxamic Acid
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Stop use and ask a doctor if rash occurs
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Hawaiian Natural Zinc Sunscreen SPF 50 Zinc Oxide GLYCERIN WATER ALOE VERA LEAF KUKUI NUT OIL PLUMERIA ALBA FLOWER CETYL DIMETHICONE 25 MAGNESIUM SULFATE ANHYDROUS ARABICA COFFEE BEAN COCONUT SUNFLOWER OIL VANILLA CAPRYLYL CAPRYLATE/CAPRATE POLYHYDROXYSTEARIC ACID (2300 MW) APRICOT MUSKMELON KAOLIN 1,2-HEXANEDIOL GALACTOARABINAN MACADAMIA OIL COCONUT OIL HYDROGENATED METHYL ABIETATE PROPANEDIOL POLYGLYCERYL-2 STEARATE COFFEA ARABICA FRUIT NONI FRUIT JUICE ARTHROSPIRA PLATENSIS RICE BRAN ROSEMARY CRANBERRY BANANA APPLE TOCOPHEROL CAPRYLHYDROXAMIC ACID ZINC OXIDE ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES SANDALWOOD
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Hawaiian Natural Zinc Sunscreen Broad Spectrum SPF 50 Water Resistant 80 minutes 89 mL / 3 FL OZ Tube box
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings: For external use only Do not use or broken skin When using this product keep out of eyes
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API