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Product NDC Code | 70412-238 | ||||||||||||||
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Drug Name | Spf30 sunscreen |
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Type | Brand | ||||||||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||||||||
Dosage Form | SPRAY | ||||||||||||||
Application Number | M020 | ||||||||||||||
Labeler Name | Zhejiang Ayan Biotech Co., Ltd. | ||||||||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Avobenzone 3%, Homosalate 10%, Octocrylene 10%, 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 Non-Water Resistant Product Apply liberally 15 minutes before sun exposure Use a water resistant sunscreen if swimming or sweating Reapply 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.inactive ingredients. Water, Glycerin, Potassium Cetyl Phosphate, VP/Hexadecene Copolymer, Dimethicone, Phenoxyethanol, Acrylates/Beheneth-25 Methacrylate Copolymer, Caprylyl Glycol, Bisabolol, Fragrance, Triethanolamine, Disodium EDTA
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
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.SPF30 Sunscreen Avobenzone, Homosalate, Octocrylene, Ocitsalate WATER GLYCERIN POTASSIUM CETYL PHOSPHATE CETOSTEARYL ALCOHOL DIMETHICONE CAPRYLYL GLYCOL PHENOXYETHANOL GLYCERYL MONOSTEARATE VINYLPYRROLIDONE/HEXADECENE COPOLYMER LEVOMENOL CARBOXYPOLYMETHYLENE TROLAMINE EDETATE DISODIUM ANHYDROUS COCONUT AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE
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.Label 8mL 10mL 20mL 30mL 60mL
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 help or contact a Poison Control Center right away.
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: Spending time in the sun increases your risk of skin cnacer or early skin aging. this product has been shown only to prevent sunburn skin cancer or early skin aging. this product is water resistant or sweat resistant. Skin Cancer/Skin Aging Alert: NOT NOT 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. Stop use and ask a doctor if rash occurs.
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