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| Product NDC Code | 72096-102 | ||||
|---|---|---|---|---|---|
| Drug Name | Hawaiian natural zinc sunscreen broad spectrum tinted spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| 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 Ingredients Non Nano Zinc Oxide 18% Purpose 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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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
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
Spl product data elements
Usually a list of ingredients in a drug product.Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30 Zinc Oxide MEDIUM-CHAIN TRIGLYCERIDES PLUMERIA ALBA FLOWER ZINC OXIDE ZINC OXIDE COCO-CAPRYLATE/CAPRATE MACADAMIA OIL ARABICA COFFEE BEAN KAOLIN WATER POLYGLYCERYL-2 OLEATE GALACTOARABINAN DIHEPTYL SUCCINATE PROPANEDIOL GLYCERIN ALOE VERA LEAF TETRASODIUM GLUTAMATE DIACETATE SUNFLOWER OIL SODIUM LEVULINATE SODIUM ANISATE VANILLA BEAN APRICOT CAPRYLHYDROXAMIC ACID POLYGLYCERYL-2 STEARATE POLYHYDROXYSTEARIC ACID (2300 MW) HYDROGENATED METHYL ABIETATE MAGNESIUM SULFATE, UNSPECIFIED FORM NONI FRUIT ARTHROSPIRA PLATENSIS ROSEMARY CINNAMON BARK OIL CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW
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.Kokua Sun Care Tinted SPF 30 Hawaiian Natural Zinc Sunscreen Broad Spectrum SPF 30 80 Minutes Water Resistant 89 ML/ 3 FL OZ kokua tinted SPF 30
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 on damaged skin When using this product keep out of eyes. Rinse with water to remove
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