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| Product NDC Code | 83108-110 | ||||
|---|---|---|---|---|---|
| Drug Name | The global travel kit |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| Application Number | M020 | ||||
| Labeler Name | Rationale Group Pty Ltd | ||||
| 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 Ingredient Zinc Oxide 24% Purpose Sunscreen
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. Reapply at least every 2 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 ageing. 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.- 2p.m. Wear long sleeved shirts, pants, hats and sunglasses. Children under 6 months of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Trisiloxane, Isoamyl Laurate, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Cyclopentasiloxane, PEG-10 Dimethicone, Ethylhexyl Methoxycrylene, Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Aqua (Water), Styrene/Acrylates Copolymer, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Pentaerythrityl Tetraisostearate, Methyl Methacrylate Crosspolymer, Propanediol, Isostearic Acid, Glyceryl Caprylate, CI 77891 (Titanium Dioxide), Polyhydroxystearic Acid, Boron Nitride, 1,2-Hexanediol, Mica, Disteardimonium Hectorite, Glycerin, Sodium Chloride, CI 77492 (Iron Oxides), Bisabolol, Propylene Carbonate, Camellia Sinensis Leaf Extract, Hydrolyzed Keratin, Caprylhydroxamic Acid, Sodium Potassium Aluminum Silicate, Limonene, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Citrus Aurantium Dulcis (Orange) Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, 7-Dehydrocholesterol, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Maltodextrin, Silica, CI 77491 (Iron Oxides), Anigozanthos Flavidus Flower Extract, Syzygium Luehmannii Fruit Extract, Tin Oxide, Aspalathus Linearis Leaf Extract, Butylene Glycol, Sodium Lactate, Sodium PCA, Melanin, CI 77499 (Iron Oxides), Pentylene Glycol, Ceteareth-25, Linalool, Dimethicone, Magnesium Aspartate, Zinc Gluconate, Cetyl Alcohol, Citronellol, Sodium Hyaluronate, Davidsonia Pruriens Fruit Extract, Sodium Benzoate, Glycine, Ethylhexylglycerin, Potassium Sorbate, Behenic Acid, Ceramide NP, Cholesterol, Copper Gluconate, Fructose, Inositol, Lactic Acid, Niacinamide, Urea, Phenoxyethanol, Citric Acid, Ceramide NS, Serine, Glutamic Acid, Ceramide AP, Ceramide EOP, Ceramide EOS, Aspartic Acid, Leucine, Acetyl Tetrapeptide-22, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Proline, Threonine, Valine, Isoleucine, Histidine.
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 ageing 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.The Global Travel Kit ZINC OXIDE The Tinted Serum Broad Spectrum SPF 50 ZINC OXIDE TRISILOXANE ISOAMYL LAURATE ALKYL (C12-15) BENZOATE BUTYLOCTYL SALICYLATE CYCLOMETHICONE 5 ETHYLHEXYL METHOXYCRYLENE WATER STYRENE TRICONTANYL POVIDONE ARGAN OIL .ALPHA.-TOCOPHEROL ACETATE PENTAERYTHRITYL TETRAISOSTEARATE PROPANEDIOL ISOSTEARIC ACID GLYCERYL CAPRYLATE TITANIUM DIOXIDE BORON NITRIDE 1,2-HEXANEDIOL MICA DISTEARDIMONIUM HECTORITE GLYCERIN SODIUM CHLORIDE FERRIC OXIDE YELLOW LEVOMENOL PROPYLENE CARBONATE GREEN TEA LEAF CAPRYLHYDROXAMIC ACID SODIUM POTASSIUM ALUMINUM SILICATE LIMONENE, (+)- CITRUS BERGAMIA LEAF OIL ORANGE OIL, COLD PRESSED JUNIPERUS DEPPEANA WOOD OIL GERANIUM OIL, ALGERIAN TYPE 7-DEHYDROCHOLESTEROL CITRUS AURANTIUM FLOWER OIL CLOVE LEAF OIL MALTODEXTRIN SILICON DIOXIDE ANIGOZANTHOS FLAVIDUS FLOWERING TOP SYZYGIUM LUEHMANNII FRUIT STANNIC OXIDE ASPALATHUS LINEARIS LEAF BUTYLENE GLYCOL SODIUM LACTATE SODIUM PYRROLIDONE CARBOXYLATE FERROSOFERRIC OXIDE PENTYLENE GLYCOL CETEARETH-25 LINALOOL, (+/-)- DIMETHICONE, UNSPECIFIED MAGNESIUM ASPARTATE ZINC GLUCONATE CETYL ALCOHOL .BETA.-CITRONELLOL, (R)- HYALURONATE SODIUM DAVIDSONIA PRURIENS FRUIT SODIUM BENZOATE GLYCINE ETHYLHEXYLGLYCERIN POTASSIUM SORBATE BEHENIC ACID CERAMIDE NP CHOLESTEROL COPPER GLUCONATE FRUCTOSE INOSITOL LACTIC ACID, UNSPECIFIED FORM NIACINAMIDE UREA PHENOXYETHANOL CITRIC ACID MONOHYDRATE CERAMIDE NS SERINE GLUTAMIC ACID CERAMIDE AP CERAMIDE EOS ASPARTIC ACID LEUCINE CAPROOYL PHYTOSPHINGOSINE N-HEXANOYLSPHINGOSINE ALANINE LYSINE ARGININE TYROSINE PHENYLALANINE PROLINE THREONINE VALINE ISOLEUCINE HISTIDINE ZINC OXIDE ZINC CATION
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 Labeling: Kit (83108-110-00) Kit0.jpg
Package Labeling: Drug Kit Component (83108-001-25) Box.jpg
Package Labeling: Non-Drug Kit Components 1Serum 2LightCreme 4Cleanser 5Serum 6NightCreme
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other Information Protect the product in this container from excessive heat and direct sun.
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 swallowed, get medical help or contact a Poison Control Center right away.
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 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