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Miami beach body white gold spf 50 - Medication Information

Product NDC Code 71130-236
Drug Name

Miami beach body white gold spf 50

Type Brand
Pharm Class Copper Absorption Inhibitor [EPC],
Decreased Copper Ion Absorption [PE]
Active Ingredients
Titanium dioxide 60 mg/ml
Zinc oxide 125 mg/ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Miami Beach Brands, Corp.
Packages
Package NDC Code Description
71130-236-08 236 ml in 1 bottle (71130-236-08)
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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