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Product NDC Code | 71130-236 | ||||
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Drug Name | Miami beach body white gold 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 | Miami Beach Brands, Corp. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Titanium Dioxide 6.00% Zinc Oxide 12.50% 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 liberally 15 minutes before sun exposure. Reapply: - At least every two hours - Immediately after swimming, sweating or towel drying. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: SUN PROTECTION MEASURES: - Limit time in the sun, especially between 10am and 2pm. - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Seed Oil, Ethylhexylgycerin, Ethylhexyl Palmitate, Glycerin, Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polysorbate-20, Tetrasodium EDTA, Styrene/Acrylates Copolymer, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum, Zemea (Corn) Propanediol.
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 measure (see directions), decrease the risk of skin cancer and early skin aging caused by the sun.
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.Miami Beach Body White Gold SPF 50 TITANIUM DIOXIDE, ZINC OXIDE ALOE VERA LEAF WATER BUTYLOCTYL SALICYLATE GREEN TEA LEAF CITRIC ACID MONOHYDRATE WATERMELON CARROT SEED OIL ETHYLHEXYLGLYCERIN ETHYLHEXYL PALMITATE GLYCERIN HELIANTHUS ANNUUS FLOWERING TOP PHENOXYETHANOL POLYSORBATE 20 EDETATE SODIUM VITIS VINIFERA SEED XANTHAN GUM CORN TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION
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: Bottle
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
Addition Information: Protect this product from excessive heat and direct sunlight.
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 attention or contact poison control center immediately.
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. When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical attention or contact 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