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| Product NDC Code | 35192-044 | ||||
|---|---|---|---|---|---|
| Drug Name | Mineral sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | EMULSION | ||||
| Application Number | M020 | ||||
| Labeler Name | CA-Botana International | ||||
| 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 Zinc Oxide 21%............................................. 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.Dosage & Administration Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Usea water resistant sunscreen if swimming or sweating. Reapply : at least 2 hours. Children under 6 months: Ask a doctor. Sun protections measurements. 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 othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m Wear long-sleeveshirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua), Coco-Caprylate/Caprate, Ceteary Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Butyrospermun parki (Shea butter), Cetearyl Olivate, Sorbitan Olivate, Caaprylhydroxamic acid. GlycerylCaprylate, Glycerin, Xanthan Gum, Equisetum arvense (Horsetail) extract, Rosmarinus officinalis (Rosemary) extract, Centella asiatica(Gotu-kola) extract, Aesculus hippocastanum (Horse chestnut) extract, Camellia sinensis(Green tea) extract, Olea europaea (Olive) extract, Tocopheryl Acetate, Potassium Acetate, Sodium Phytate, Citrus nobilis/Mandarinorage) Peel oil, Coconut oil, Helianthus annuus (Sunflower) Seed oil, Silica, Triethpxycapryylsilane, OXY CA (Rosmarinus officnalis (Leaf)CO2 Extract& Ascorbyl Palmitate & Caprylic/Capric Triglyceride & Ascorbic Acid & Tocopherol & Citric 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.Indications & Usage Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Mineral Sunscreen Zinc Oxide SORBITAN OLIVATE EQUISETUM ARVENSE WHOLE ASCORBIC ACID SUNFLOWER OIL DIMETHICONOL TRIETHOXYCAPRYLYLSILANE TETRAETHYL SILICATE CROSSPOLYMER (4000000 MW) STEARYL ALCOHOL POLYHYDROXYSTEARIC ACID (2300 MW) CETEARYL OLIVATE ALLANTOIN ROSEMARY HEXASODIUM PHYTATE ZINC OXIDE ZINC OXIDE POTASSIUM SORBATE ETHYL FERULATE TOCOPHEROL XANTHAN GUM GLYCERIN PROPANEDIOL WATER ANHYDROUS CITRIC ACID COCO-CAPRYLATE/CAPRATE CAPRYLHYDROXAMIC ACID GLYCERYL CAPRATE CENTELLA ASIATICA GREEN OLIVE .ALPHA.-TOCOPHEROL ACETATE, DL- ORANGE PEEL COCOS NUCIFERA WHOLE HYDRATED SILICA ASCORBYL PALMITATE MICA CETOSTEARYL ALCOHOL MEDIUM-CHAIN TRIGLYCERIDES HORSE CHESTNUT GREEN TEA LEAF SHEA BUTTER white yellowish
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.PACKAGE LABEL PRINCIPAL Gabriel-Sunscreen-Label.8( 1)
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask Doctor Stop use and ask a doctor if rash occurs
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 Keep out of reach of children
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Safety information Protect this product from excessive heat and direct sun
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. If product is swallowed get medical help or contact a poison Control Center right away.
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