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Suntone spf 50 - Medication Information

Product NDC Code 58443-0525
Drug Name

Suntone spf 50

Type Brand
Active Ingredients
Avobenzone 29.4 mg/ml
Homosalate 98 mg/ml
Octisalate 49 mg/ml
Octocrylene 49 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Prime Enterprises, Inc.
Packages
Package NDC Code Description
58443-0525-4 177 ml in 1 bottle (58443-0525-4)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 5%

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: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 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 sun protection measures including: limit time in the sun, especially from 10 a.m. - 2 p.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 Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Ethylhexylglycerin, Fragrance, Hydroxypropyl Methylcellulose, Phenoxyethanol, Polyethylene, Polysorbate 20, Propylene Glycol, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Water

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen 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

Spl product data elements

Usually a list of ingredients in a drug product.
Suntone SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene EDETATE DISODIUM ANHYDROUS ETHYLHEXYLGLYCERIN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) ALKYL (C12-15) BENZOATE CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE HYPROMELLOSES PROPYLENE GLYCOL ALOE VERA LEAF PHENOXYETHANOL POLYSORBATE 20 SODIUM HYDROXIDE ALPHA-TOCOPHEROL ACETATE HIGH DENSITY POLYETHYLENE SORBITAN MONOOLEATE COCOA BUTTER WATER HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE White to Off White

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.
Suntone Sport Sunscreen Lotion Broad Spectrum SPF50 Principle Display 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.
Other information Protect form excessive heat and direct sun may stain or damage some fabrics or surfaces

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 product is swallowed, get medical help or contact a Poison Control Center right away.

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? Biocycle Laboratories, Inc. 16363 NW 49 Avenue, Miami, FL 33014

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 produc t keep out of eyes. Rinse with water to remove. Keep away from dace to avoid breathing it.

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 produc t keep out of eyes. Rinse with water to remove. Keep away from dace to avoid breathing it. Stop use and ask a doctor if rash occurs Keep out of reach of children. 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