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Product NDC Code | 58668-9611 | ||||||
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Drug Name | Multi-active jour spf 20 broad spectrum sunscreen |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
Application Number | M020 | ||||||
Labeler Name | Laboratoires Clarins | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients AVOBENZONE 3% HOMOSALTE 9% OCTOCRYLENE 2.7% 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 • apply to all skin exposed to the sun • 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 this 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 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 AQUA/WATER/EAU . GLYCERIN . BUTYLOCTYL SALICYLATE . DIMETHICONE . C12-15 ALKYL BENZOATE . CETEARYL ALCOHOL . PROPANEDIOL . POTASSIUM CETYL PHOSPHATE . PARFUM/FRAGRANCE . CELLULOSE . CETEARYL GLUCOSIDE . DIPSACUS SYLVESTRIS EXTRACT . PHENOXYETHANOL . ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER . CAPRYLYL GLYCOL . CI 77891/TITANIUM DIOXIDE . TROMETHAMINE . SYNTHETIC FLUORPHLOGOPITE . DISODIUM EDTA . TOCOPHERYL ACETATE . XANTHAN GUM . SODIUM HYALURONATE . DIMETHICONOL . TOCOPHEROL . BUTYLENE GLYCOL . DIOSPYROS MESPILIFORMIS LEAF EXTRACT . MALTODEXTRIN . SANICULA EUROPAEA EXTRACT . MYROTHAMNUS FLABELLIFOLIA EXTRACT . CITRIC ACID . LAPSANA COMMUNIS FLOWER/LEAF/ STEM EXTRACT . FURCELLARIA LUMBRICALIS EXTRACT . SODIUM CITRATE . POTASSIUM SORBATE . ASCORBIC ACID . GLYCOLIC ACID . LACTIC ACID . MARIS SAL/SEA SALT/SEL MARIN . CI 14700/RED 4 . CI 17200/RED 33 . POLYVINYL ALCOHOL . COPPER PALMITOYL HEPTAPEPTIDE-14 . HEPTAPEPTIDE-15 PALMITATE. [S2912A]
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.Multi-Active Jour SPF 20 Broad Spectrum Sunscreen AVOBENZONE,HOMOSALATE,OCTOCRYLENE XANTHAN GUM HYALURONATE SODIUM TOCOPHEROL BUTYLENE GLYCOL DIOSPYROS MESPILIFORMIS LEAF MALTODEXTRIN CITRIC ACID MONOHYDRATE LAPSANA COMMUNIS FLOWERING TOP FURCELLERAN SODIUM CITRATE POTASSIUM SORBATE ASCORBIC ACID GLYCOLIC ACID LACTIC ACID FD&C RED NO. 4 D&C RED NO. 33 POLYVINYL ALCOHOL, UNSPECIFIED AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE WATER GLYCERIN BUTYLOCTYL SALICYLATE DIMETHICONE ALKYL (C12-15) BENZOATE CETOSTEARYL ALCOHOL PROPANEDIOL POTASSIUM CETYL PHOSPHATE POWDERED CELLULOSE CETEARYL GLUCOSIDE PHENOXYETHANOL CAPRYLYL GLYCOL TITANIUM DIOXIDE TROMETHAMINE EDETATE DISODIUM ANHYDROUS .ALPHA.-TOCOPHEROL ACETATE
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: Outer Label Inner Label
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 this product 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 product is swallowed, get medical help or contact a Poison Control Center right away.
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? Call 1-866-325-2746 Monday-Friday 9am to 6:30pm ET
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