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Product NDC Code | 43526-129 | ||||
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Drug Name | Ipkn moist and firm beauty balm light medium |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M020 | ||||
Labeler Name | Inel Cosmetics Co., Ltd. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Titanium Dioxide 6.51%
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.For sunscreen use: Apply liberally 15 minutes before sun exposure Reapply at least every two hours Use a water-resistant sunscreen if swimming or sweating 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses Ask a doctor to use for children under 6 months
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Cyclopentasiloxane, Titanium Dioxide (CI 77891), Glycerin, Iron Oxides (CI 77492), PEG-10 Dimethicone, Phenyl Trimethicone, Triethylhexanoin, Isododecane, Octyldodecanol, Cetyl Ethylhexanoate, Dipropylene Glycol, Hexyl Laurate, Isoeicosane, Niacinamide, Pentylene Glycol, Mica (CI 77019), Butylene Glycol Dicaprylate/Dicaprate, Disteardimonium Hectorite, Panthenol, Talc, Magnesium Sulfate, Iron Oxides (CI 77491), Acrylates/Dimethicone Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Sorbitan Sesquioleate, Iron Oxides (CI 77499), Polyglyceryl-4 Isostearate, Aluminum Hydroxide, Triethoxycaprylylsilane, Stearic Acid, Alumina, Glyceryl Behenate/Eicosadioate, Glyceryl Caprylate, Isopropyl Titanium Triisostearate, Hydrolyzed Hyaluronic Acid, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Adenosine, Trisodium Ethylenediamine Disuccinate, Moringa Oleifera Seed Oil, Ceramide NP, Phytosphingosine, Hydrogenated Lecithin
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 If used as directed with other sun protection measures (see Directions) decrease the risk of skin cancer and early skin 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.IPKN Moist and Firm Beauty Balm Light Medium Titanium Dioxide HEXYL LAURATE ISOEICOSANE NIACINAMIDE PENTYLENE GLYCOL MICA BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE DISTEARDIMONIUM HECTORITE PANTHENOL TALC MAGNESIUM SULFATE, UNSPECIFIED FORM FERRIC OXIDE RED 2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) SORBITAN SESQUIOLEATE FERROSOFERRIC OXIDE POLYGLYCERYL-4 ISOSTEARATE ALUMINUM HYDROXIDE TRIETHOXYCAPRYLYLSILANE STEARIC ACID ALUMINUM OXIDE GLYCERYL BEHENATE/EICOSADIOATE GLYCERYL MONOCAPRYLATE ISOPROPYL TITANIUM TRIISOSTEARATE HYALURONIC ACID VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER ADENOSINE TRISODIUM ETHYLENEDIAMINE DISUCCINATE MORINGA OLEIFERA SEED OIL CERAMIDE NP PHYTOSPHINGOSINE HYDROGENATED SOYBEAN LECITHIN TITANIUM DIOXIDE CI 77891 WATER CYCLOMETHICONE 5 GLYCERIN FERRIC OXIDE YELLOW PEG-10 DIMETHICONE (200 CST) PHENYL TRIMETHICONE TRIETHYLHEXANOIN ISODODECANE OCTYLDODECANOL CETYL ETHYLHEXANOATE DIPROPYLENE GLYCOL
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.image description
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 the children. If product is 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. For external use only Do not use on damaged or broken skin Stop using and ask a doctor if rash occurs When using this product, keep out of eyes. Rinse with water to remove 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