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| Product NDC Code | 84610-100 | ||||||||
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| Drug Name | Anua heartleaf silky moisture mild sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | The Founders 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 3.0% Homosalate 7.3% Octisalate 5.0% Octocrylene 9.0%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Drug Facts Active Ingredients Avobenzone 3.0% Homosalate 7.3% Octisalate 5.0% Octocrylene 9.0% Purpose Sunscreen 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. Warnings 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 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Directions For sunscreen use: ■ apply liberally 15 minutes before sun exposure ■ children under 6 months of age: Ask a doctor ■ 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 ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating Other Information ■ Protect the product in this container from excessive heat and direct sun Inactive ingredients Water, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Nylon-12, Silica, Sodium Acrylates Crosspolymer-2, 1,2-Hexanediol, Pentylene Glycol, Polyglyceryl-3 Distearate, Hydroxyethyl Urea, Cetearyl Olivate, Potassium Cetyl Phosphate, Butylene Glycol, Sorbitan Olivate, Cetyl Alcohol, Houttuynia Cordata Extract, Carbomer, Glycerin, Panthenol, Xanthan Gum, Glyceryl Stearate Citrate, Ethylhexylglycerin, Disodium EDTA, Acetyl Glucosamine, Sodium Hyaluronate, Cryptomeria Japonica Leaf Extract, Nelumbo Nucifera Leaf Extract, Saccharomyces Ferment, Hydroxyacetophenone, Cynanchum Atratum Extract, Sodium Hyaluronate Crosspolymer, Althaea Rosea Flower Extract, Tocopherol, Dimethylsilanol Hyaluronate, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Caprylyl Glycol, Hyaluronic Acid, Potassium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate Questions ? +82 1688-9407 Contact information : www.anua.us
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 For sunscreen use: ■ apply liberally 15 minutes before sun exposure ■ children under 6 months of age: Ask a doctor ■ 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 ■ 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, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Nylon-12, Silica, Sodium Acrylates Crosspolymer-2, 1,2-Hexanediol, Pentylene Glycol, Polyglyceryl-3 Distearate, Hydroxyethyl Urea, Cetearyl Olivate, Potassium Cetyl Phosphate, Butylene Glycol, Sorbitan Olivate, Cetyl Alcohol, Houttuynia Cordata Extract, Carbomer, Glycerin, Panthenol, Xanthan Gum, Glyceryl Stearate Citrate, Ethylhexylglycerin, Disodium EDTA, Acetyl Glucosamine, Sodium Hyaluronate, Cryptomeria Japonica Leaf Extract, Nelumbo Nucifera Leaf Extract, Saccharomyces Ferment, Hydroxyacetophenone, Cynanchum Atratum Extract, Sodium Hyaluronate Crosspolymer, Althaea Rosea Flower Extract, Tocopherol, Dimethylsilanol Hyaluronate, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Caprylyl Glycol, Hyaluronic Acid, Potassium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate
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.ANUA HEARTLEAF SILKY MOISTURE MILD SUNSCREEN Avobenzone, Homosalate, Octisalate, Octocrylene BUTYLOCTYL SALICYLATE NYLON-12 SILICON DIOXIDE CETEARYL OLIVATE SODIUM ACRYLATES CROSSPOLYMER-2 SORBITAN OLIVATE WATER OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE XANTHAN GUM PENTYLENE GLYCOL OCTISALATE OCTISALATE CARBOMER 940 DIMETHYLSILANOL HYALURONATE POTASSIUM CETYL PHOSPHATE HYDROXYACETOPHENONE HYALURONIC ACID 1,2-HEXANEDIOL HYDROXYETHYL UREA GLYCERIN N-ACETYLGLUCOSAMINE PROPANEDIOL ETHYLHEXYL METHOXYCRYLENE PANTHENOL CETYL ALCOHOL ETHYLHEXYLGLYCERIN EDETATE DISODIUM CRYPTOMERIA JAPONICA LEAF NELUMBO NUCIFERA LEAF ALCEA ROSEA FLOWER GLYCERYL STEARATE CITRATE CAPRYLYL GLYCOL SODIUM ACETYLATED HYALURONATE POLYGLYCERYL-3 DISTEARATE HOUTTUYNIA CORDATA FLOWERING TOP HYALURONATE SODIUM BUTYLENE GLYCOL TOCOPHEROL AVOBENZONE AVOBENZONE POLYACRYLIC ACID (450000 MW)
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.PACKAGE LABEL ANUA HEARTLEAF SILKY MOISTURE MILD SUNSCREEN
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 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 the product in this container 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.Questions ? +82 1688-9407 Contact information : www.anua.us
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 occurs
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 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 Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
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