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| Product NDC Code | 81100-501 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Isntree hyaluronic acid daily sungel |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M020 | ||||||
| Labeler Name | ISNTREE Inc. | ||||||
| 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 Avobenzone 2.7 % Homosalate 9 % Octisalate 4.5 %
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. 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 value 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-sleeved shirts, pants, hats, and sunglasses ■ children under 6 months of age: Ask a doctor ■ reapply at least every 2 hours. ■ use a water-resistant sunscreen if swimming or sweating.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Butyloctyl Salicylate, Butylene Glycol, Diethylhexyl 2,6-Naphthalate, Niacinamide, C20-22 Alkyl Phosphate, C20-22 Alcohols, 1,2-Hexanediol, Pentylene Glycol, Acrylates Copolymer, Polymethylsilsesquioxane, Cetyl Alcohol, Poly C10-30 Alkyl Acrylate, VP/Eicosene Copolymer, Glyceryl Stearate, Silica, Tromethamine, Propanediol, Polyacrylate Crosspolymer-6, Xanthan Gum, Ethylhexylglycerin, Adenosine, Portulaca Oleracea Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Dimethylsilanol Hyaluronate, Hyaluronic Acid, Sodium Hyaluronate, Potassium Hyaluronate, Sodium Hyaluronate Crosspolymer, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate, Tocopherol, Ectoin, Dipropylene Glycol, Sodium Palmitoyl Proline, Glycerin, Beta-Glucan, Nymphaea Alba Flower Extract
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 • 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.ISNTREE HYALURONIC ACID DAILY SUNGEL Avobenzone, Homosalate, Octisalate POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) XANTHAN GUM ADENOSINE DIETHYLHEXYL 2,6-NAPHTHALATE NIACINAMIDE CETYL ALCOHOL SILICON DIOXIDE PROPANEDIOL HYALURONIC ACID SODIUM PALMITOYL PROLINE GLYCERIN ETHYLHEXYLGLYCERIN HOMOSALATE HOMOSALATE AVOBENZONE AVOBENZONE SODIUM ACETYLATED HYALURONATE BUTYLENE GLYCOL DIMETHYLSILANOL HYALURONATE HYALURONATE SODIUM C20-22 ALCOHOLS TOCOPHEROL DIPROPYLENE GLYCOL PENTYLENE GLYCOL TROMETHAMINE CENTELLA ASIATICA TRITERPENOIDS HOUTTUYNIA CORDATA FLOWERING TOP OCTISALATE OCTISALATE PURSLANE ECTOINE WATER GLYCERYL MONOSTEARATE AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) NYMPHAEA ALBA FLOWER BUTYLOCTYL SALICYLATE C20-22 ALKYL PHOSPHATE 1,2-HEXANEDIOL
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.ISNTREE HYALURONIC ACID DAILY SUN GEL
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 skin 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 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 the product from exessive heat and direct sun ■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
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 or irritation develops and lasts.
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.
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