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| Product NDC Code | 11045-0303 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Soleo organics sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | SE Operations Pty Ltd | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients (USA/AUS) Zinc oxide 22.3% w/w
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 Squeeze cream and shake tube well before use apply liberally 20 minutes before sun exposure and as needed store below 30°C/86°F
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Beeswax, candelilla wax, caprylic/capric triglyceride (plant sourced), coconut extract, cucumber extract, cupuacu butter, grapeseed oil, green tea leaf extract, lecithin, macadamia oil, roman chamomile extract, safflower oil, sunflower oil, vegetable oil, vitamin E (natural)
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 higher SPF gives more sunburn protection provides high protection against sunburn retains SPF after 80 minutes of activity in the water
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.Soleo Organics Sunscreen Zinc Oxide Zinc Oxide Zinc Oxide GRAPE SEED OIL SUNFLOWER OIL MEDIUM-CHAIN TRIGLYCERIDES CANDELILLA WAX YELLOW WAX MACADAMIA OIL THEOBROMA GRANDIFLORUM SEED BUTTER GREEN TEA LEAF CHAMAEMELUM NOBILE FLOWER LECITHIN, SOYBEAN SAFFLOWER OIL CUCUMBER .ALPHA.-TOCOPHEROL
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.PRINCIPAL DISPLAY PANEL - 80 g Tube Carton MULTI AWARD WINNING # 1 SUNSCREEN soléo ® organics ORIGINAL FORMULA HIGH PERFORMANCE • SE FORMULA • SE FORMULA ALL NATURAL SUNSCREEN SPF 30 3hour very water resistant* UV-A UV-B Broad Spectrum 80g/2.8 oz e AUST-L 116246 PRINCIPAL DISPLAY PANEL - 80 g Tube Carton
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
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
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 When using this product keep out of eyes, rinse with water to remove Keep out of reach of children Avoid prolonged exposure to the sun Wear protective clothing, hats and eye wear when in the sun Stop use and ask a doctor if rash or irritation develops and lasts
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