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| Product NDC Code | 65112-304 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Sunplus spf50 face body sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | I.Shay Cosmetics | ||||||||
| 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.Homosalate- 15% Octocrylene- 6% Octisalate- 5% Avobenzone- 2%
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.Apply liberally to dry skin 15 minutes before sun exposure. Reapply to dry skin after 80 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours. Children under 6 months ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Purified Water, Glycerin, Ceteareth-20, Cetearyl Alcohol, Dimethicone, Glyceryl stearate, PEG-100, Acrylic Polymer, Cetyl Alcohol, Potassium Hexadecyl Phosphate, PEG 300, Grapeseed Oil, Sunflower Oil, Safflower Oil, Organic Borage Oil, Organic Evening Primrose Oil, Allantoin, Hyaluronic Acid, Organic Raspberry Seed Oil, Organic Jojoba Oil, Organic Aloe Oil, Phenoxyethanol, Ethylhexylglycerin
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.Helps prevent sunburn and photodamage. If used as directed with other sun protection measures, decreases the risk of skin cancer and early aging caused by the sun.
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Sunplus SPF50 Face Body Sunscreen Sunscreen OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE WATER HOMOSALATE HOMOSALATE AVOBENZONE AVOBENZONE
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.Sunplus SPF 50
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.WARNING - Keep out of reach of children
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.For external use only. Do not use on damaged or broken skin. When using this product keep out f eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation occurs. If swallowed get medical help or contact Poison Control Center. Keep out of reach of children.
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