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| Product NDC Code | 83478-000 | ||||
|---|---|---|---|---|---|
| Drug Name | Sett mineral sunscreen spf 50 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Sett Surf, Ltd. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS Zinc Oxide (non-nano) 12.5% Titanium Dioxide (non-nano) 4.5% 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 • Shake well before use • Apply liberally to all exposed skin 15 minutes before sun exposure • - after 80 minutes of swimming or sweating • Immediately after towel drying - At least every 2 hours • Sun Protection Measures: Spending time in the sun increaases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection measres including: • Limit time in the sun, especially between 10am and 2pm • Wear long-sleeved shorts, pants, hats and sunglasses • For children under 6 months of age - ask a doctor. Reapply
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Aqua, Glycine Max (Soybean) Oil, Hydroxy Ethyl Cellulose (Cellulose Gum), Xanthan Gum, Glycerol Mono Stearate, Barium Sulphate, Cetearyl Alcohol, Glycerin, Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Copernicia Cerifera (Carnauba) Wax, Sodium Benzoate, Potassium Sorbate, Potassium Cetyl Phosphate, Cucumber Potpourri, Citrullus Vulgaris (Kalahari Melon) Oil, Simmondsia Chenensis (Jojoba) Oil, Argania Spinosa (Argan) Oil, Aloe Vera Extract, Ascorbic Acid (Vitamin C), Tocopherol Acetate (Vitamin E).
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 othe sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions
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.SETT Mineral Sunscreen SPF 50 ZINC OXIDE, TITANIUM DIOXIDE WATER SOYBEAN OIL HYDROXYMETHYL CELLULOSE XANTHAN GUM BARIUM SULFATE CETOSTEARYL ALCOHOL GLYCERIN COCONUT OIL CASTOR OIL HYDROGENATED CASTOR OIL CARNAUBA WAX SODIUM BENZOATE POTASSIUM SORBATE POTASSIUM CETYL PHOSPHATE JOJOBA OIL ARGAN OIL ALOE VERA LEAF ASCORBIC ACID .ALPHA.-TOCOPHEROL ACETATE ZINC OXIDE ZINC CATION TITANIUM DIOXIDE TITANIUM DIOXIDE
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 Labeling: Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.DRUG FACTS
OTHER INFORMATION Store below 90ºF / 30ºC
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 swallowed, get medical help or contact a Poison Control Center right away.
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.
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. Stop use and ask a doctor if rash occurs. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If 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