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Product NDC Code | 81208-203 | ||||||||
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Drug Name | Kizo lab uv defense clear sunscren spf50 |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | GEL | ||||||||
Application Number | M020 | ||||||||
Labeler Name | YB CHEMIA LLC | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Drug Facts Active Ingredients ……………….….. Purpose Avobenzone 3.0% ……………… Sunscreen Homosalate 8.0% ……………… Sunscreen Octisalate 5.0% ……………… Sunscreen Octocrylene 4.0% ……………… Sunscreen
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.KIZO LAB UV DEFENSE SPF50 KIZO LAB UV DEFENSE SPF50
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 Rub in well. Reapply at least every 2 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Acetyl Hexapeptide-1, C12-15 Alkyl Benzoate, C18-36 Acid Glycol Ester, C18-36 Acid Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Capryloyl Glycine, Caprylyl Glycol, Coprinus Comatus (Mushroom) Extract, Cordyceps Sinensis Extract, Dicaprylyl Carbonate, Dimethicone Crosspolymer-3, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Ganoderma Lucidum (Mushroom) Extract, Glycerin, Grifola Frondosa Extract, Isododecane, Isohexadecane, Isopropyl Palmitate, Lecithin, Meadowfoam Estolide, Neopentyl Glycol Diheptanoate, Octyldodecyl Neopentanoate, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Polyglutamic Acid, Polymethylsilsesquioxane, Rhododendron Ferrugineum Extract, Sorbitan Laurate, Terminalia Chebula Fruit Extract, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undecylenoyl Glycine, Water.
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.Indications & Usage 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.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
Spl product data elements
Usually a list of ingredients in a drug product.KIZO LAB UV DEFENSE CLEAR SUNSCREN SPF50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) CAPRYLOYL GLYCINE CAPRYLYL GLYCOL DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER DICAPRYLYL CARBONATE DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) ETHYLHEXYL METHOXYCRYLENE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE ALKYL (C12-15) BENZOATE ISOHEXADECANE WATER DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) PALMITOYL TRIPEPTIDE-1 POLYMETHYLSILSESQUIOXANE (11 MICRONS) ISODODECANE ISOPROPYL PALMITATE LECITHIN, SOYBEAN MEADOWFOAM ESTOLIDE PALMITOYL TETRAPEPTIDE-7 UNDECYLENOYL GLYCINE AVOBENZONE AVOBENZONE OCTISALATE OCTISALATE ACETYL HEXAPEPTIDE-1 C18-36 ACID TRIGLYCERIDE ETHYLHEXYLGLYCERIN GLYCERIN NEOPENTYL GLYCOL DIHEPTANOATE OCTYLDODECYL NEOPENTANOATE TETRAHEXYLDECYL ASCORBATE
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.KIZO SPF 50 BOX KIZO SPF 50BOX
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 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 in this container from excessive heat and direct sunlight
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.DIRECTIONS Apply liberally 15 minutes before sun exposure Rub in well. Reapply at least every 2 hours Children under 6 months: Ask a doctor Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially 10 a.m. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.
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 Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove.
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