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| Product NDC Code | 82601-300 | ||||||||||
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| Drug Name | Fotoskinox color face cream sunscreen broad spectrum spf 50 |
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| Type | Brand | ||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||
| Dosage Form | CREAM | ||||||||||
| Application Number | M020 | ||||||||||
| Labeler Name | HANS BIOMED S.L. | ||||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Avobnzone 3% Sunscreen Ensulizole 3% Sunscreen Octinoxate 4% Sunscreen Octocrylene 2% Sunscreen Titanium Dioxide 4.8% 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 For sunscreen use: 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 aging. To decrease this risk, reguarlry 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. to 2 p.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 Water, Cyclopentasiloxane, Titanium Dioxide (CI 77891), Dicaprylyl Ether, Propanediol, Squalane, Ethyl Macadamiate, Butylene Glycol, Triethanolamine, Poly C10-30 Alkyl Acrylate, Sodium Polyacrylate, Cetyl Alcohol, Glyceryl Stearate, Phenoxyethanol, Yellow Iron Oxide (CI 77492), Glycerin, Cellulose Acetate, Red Iron Oxide (CI 77491), PEG-75 Stearate, Acrylates/Ammonium Methacrylate Copolymer, Propylene Glycol Stearate, Ceteth-20, Steareth-20, Lecithin, Gossypium Herbaceum Callus Culture, Silica, Ethylhexylglycerin, Magnesium Stearate, Black Iron Oxide (CI 77499), Polygonum Aviculare Extract, Hydrogenated Polydecene, Alteromonas Ferment Extract, Potassium Sorbat, Sodium Benzoate, Trideceth-6, Tocopherol, Citric Acid, Malic Acid, Acetyl Hexapeptide-49, Fragrance, Citronellol, D-Limonene, Geraniol, Linalool.
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 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.FOTOSKINOX Color Face Cream Sunscreen Broad Spectrum SPF 50 Sunscreen DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) ENSULIZOLE ENSULIZOLE OCTINOXATE OCTINOXATE SQUALANE CETYL ALCOHOL PHENOXYETHANOL GLYCERIN PEG-75 STEARATE ETHYL MACADAMIATE SODIUM POLYACRYLATE (8000 MW) PROPYLENE GLYCOL STEARATE GERANIOL BUTYLENE GLYCOL AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE TITANIUM DIOXIDE TITANIUM DIOXIDE CETETH-20 GOSSYPIUM HERBACEUM FLOWER ETHYLHEXYLGLYCERIN DICAPRYLYL ETHER STEARETH-20 LECITHIN, SOYBEAN MAGNESIUM STEARATE POLYGONUM AVICULARE WHOLE HYDROGENATED POLYDECENE (1500 CST) ALTEROMONAS MACLEODII POLYSACCHARIDES MALIC ACID ACETYL HEXAPEPTIDE-49 LINALOOL, (+)- CELLULOSE ACETATE POTASSIUM SORBATE TOCOPHEROL SODIUM BENZOATE PPG-1 TRIDECETH-6 PROPANEDIOL WATER
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.OUTER PACKAGING 50 mL NDC 82601-300-01 back packaging fotoskinox crema COLOR back
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Store at 15ºC-30ºC (59ºF-86ºF) 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 or comments? [email protected]
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
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