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| Product NDC Code | 84569-123 | ||||
|---|---|---|---|---|---|
| Drug Name | Kawakids kawasun - premium mineral sunscreen spf 50 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | LCA COSMETICS LLC | ||||
| 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 Zinc Oxide (Non-Nano) 25%
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 liberally to exposed areas 15 minutes before sun exposure Reapply: after 80 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 protection measures including: Limit time in the sun, especially from 10a.m.-2p.m. 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 Aloe Barbadensis (Aloe Vera) Leaf Juice, Camellia Sinensis (Green Tea) Extract, Hamamelis Virginiana (Witch Hazel) Extract, Caprylic/Capric Trigylceride (MCT Oil), Glycerin, Propanediol, Polyglyceryl-6 Stearate, Polyglyceryl-6 Behenate, Cetyl Alcohol, Piper Excelsum (Kawakawa) Extract, Butyrospermum Parkii (Shea) Butter, Persea Americana (Avocado) Oil, Panthenol (Pro-Vitamin B-5), Tocopherol (Vitamin E) Acetate, Sargassum Fluitans/Natans Extract, Pentylene Glycol, PolyhydroxyStearic Acid, Benzyl Alcohol, Dehydroacetic Acid, Sclerotium Gum, Pullulan, Xanthan Gum, Sphingomonas Ferment Extract, Sodium Phytate.
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.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
Purpose
Information about the drug product’s indications for use.Purpose Zinc Oxide (Non-Nano) 25%.............Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.KawaKids KawaSun - Premium Mineral Sunscreen SPF 50 Zinc Oxide GLYCERIN POLYGLYCERYL-6 STEARATE MEDIUM-CHAIN TRIGLYCERIDES BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES AVOCADO OIL .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM ALOE VERA LEAF PANTHENOL DEHYDROACETIC ACID ZINC OXIDE ZINC OXIDE GREEN TEA LEAF HAMAMELIS VIRGINIANA LEAF PROPANEDIOL POLYGLYCERYL-6 BEHENATE CETYL ALCOHOL PIPER EXCELSUM LEAF PENTYLENE GLYCOL POLYHYDROXYSTEARIC ACID (2300 MW) BENZYL ALCOHOL BETASIZOFIRAN PULLULAN PHYTATE SODIUM
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.Faith & Sage Pharmacist Developed Mom Approved Premium Sunscreen Lotion KawaKids KawaSun We believe in purity Plant-derived Ingredients, Antioxidants, Vitamins E & B5, Zinc Oxide Broad Spectrum SPF 50 Reef Safe & Water Resistant (80 Min.) 50 mL/1.75 fl oz 1
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use on damaged or broken skin
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 a product is swallowed get medical help or contact a Poison Control Center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-657-789-5775
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rash occurs
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product , keep out of eyes. RInse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect this product from excessive heat and direct sun Store at room temperature
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 or broken skin When using this product , keep out of eyes. RInse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If a product is swallowed get medical help or contact a Poison Control Center immediately.
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