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Soleil toujours broad spectrum spf 30 sunscreen - Medication Information

Product NDC Code 58443-0518
Drug Name

Soleil toujours broad spectrum spf 30 sunscreen

Type Brand
Active Ingredients
Avobenzone 25.11 mg/ml
Homosalate 62.78 mg/ml
Octisalate 41.85 mg/ml
Route TOPICAL
Dosage Form LOTION
Application Number part352
Labeler Name Prime Enterprises Inc.
Packages
Package NDC Code Description
58443-0518-3 50 ml in 1 tube (58443-0518-3)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Avobenzone 3% Homosalate 7.5% Octisalate 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 Shake well before use with your eyes completely closed, mist face evenly, holding bottle 10-12 inches awat from face. Do not breathe mist in. Allow to fully dry. 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 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.
Abies siberica Needle Oil, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Bisabolol, Camellia Oleifera (Green Tea) Leaf Extract, Caprylic/Capric Triglyceride, Citrus aurantifolia Fruit Oil, Citrus aurantium bergamia Fruit Extract, Citrus aurantium dulcis Peel Oil, Citrus grandis Peel Oil, Citrus limon Peel Oil, Citrus nobilis Peel Oil, Citrus reticulata Leaf Oil, Commiphora myrrha Resin Oil, Cucumis Sativus (Cucumber) Extract, Ethyl Vanillin, Eucalyptus globulus Leaf Oil, Ferula galbaniflua Oil, Glycerin, Juniperus virginiana Oil, Lavandula angustifolia Oil, Mentha piperita Stem/Leaf Oil, Mentha viridis Leaf Oil, Myristica fragrans Kernel Oil, Pelargonium graveolens Flower Oil, Pogostemon cablin Oil, Polyester-8, Porphyra Umbilicalis Extract, Rosa damascena Flower Oil, Salvia sclarea Oil, Santalum spicata Wood Oil, SD Alcohol 40-B, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Thymus vulgaris Oil, Tocopheryl Acetate, Triethyl Citrate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vanillin, Water

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 measures (see Directions ), decreases 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.
Soleil Toujours Broad Spectrum SPF 30 Sunscreen Avobenzone, Homosalate, Octisalate BERGAMOT OIL ORANGE PEEL ALOE VERA LEAF GLYCERIN GREEN TEA LEAF WATER OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE LEMON OIL, COLD PRESSED CITRUS NOBILIS LEVOMENOL CITRUS AURANTIIFOLIA FRUIT OIL CITRUS MAXIMA FRUIT RIND OIL CITRUS RETICULATA LEAF OIL SPEARMINT OIL POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) SANTALUM SPICATUM OIL ALCOHOL TRIETHYL CITRATE VANILLIN MENTHA PIPERITA LEAF POGOSTEMON CABLIN LEAF OIL TETRAHEXYLDECYL ASCORBATE THYME OIL .ALPHA.-TOCOPHEROL ACETATE GALBANUM OIL JUNIPERUS VIRGINIANA OIL LAVENDER OIL MYRRH OIL CUCUMBER EUCALYPTUS OIL ROSA DAMASCENA FLOWER OIL CLARY SAGE OIL PELARGONIUM GRAVEOLENS FLOWER OIL ABIES SIBIRICA WHOLE ETHYL VANILLIN NUTMEG OIL PORPHYRA UMBILICALIS HYALURONATE SODIUM ASCORBYL PALMITATE MEDIUM-CHAIN TRIGLYCERIDES Very Light Yellow

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.
Soleil Toujours SPF 30 Makeup Setting Spray Sunscreen Principle Display Label

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.
Stop use and ask a doctor if rash occurs.

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 us e 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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information Protect this product from excessive heat and direct sun.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Question or comments? Call 1-877-320-2381

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 us e on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. 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. Flammable: Do not use near heat,flame or while smoking.

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