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| Product NDC Code | 58668-9918 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Clarins - extra-firming jour spf 15 - wrinkle, firming day all skin types - broad spectrum spf 15 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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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients AVOBENZONE 3% HOMOSALATE 9% OCTOCRYLENE 6.5% 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 • Spending time in the sun in creases 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 sun screen if swimming or sweating Sun Protection Measures.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: AQUA/WATER/EAU . GLYCERIN . BUTYLOCTYL SALICYLATE . BUTYROSPERMUM PARKII (SHEA) BUTTER . DIMETHICONE . C12-15 ALKYL BENZOATE . CETEARYL ALCOHOL . METHYL METHACRYLATE CROSSPOLYMER . POTASSIUM CETYL PHOSPHATE . PARFUM/FRAGRANCE . CETEARYL GLUCOSIDE . DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER . PHENOXYETHANOL . BUTYLENE GLYCOL . ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER . CAPRYLYL GLYCOL . TROMETHAMINE . AVENA SATIVA (OAT) KERNEL EXTRACT . DISODIUM EDTA . TOCOPHERYL ACETATE . XANTHAN GUM . DIMETHICONOL . TOCOPHEROL . ANIGOZANTHOS FLAVIDUS EXTRACT . CAPRYLIC/CAPRIC TRIGLYCERIDE . BETAINE . SILICA . SORBITOL . DIOSPYROS MESPILIFORMIS LEAF EXTRACT . MALTODEXTRIN . SANICULA EUROPAEA EXTRACT . SODIUM BENZOATE . KALANCHOE PINNATA LEAF EXTRACT . BALANITES ROXBURGHII SEED OIL . MITRACARPUS SCABER EXTRACT . CITRIC ACID . MALPIGHIA EMARGINATA (ACEROLA) SEED EXTRACT . LAPSANA COMMUNIS FLOWER/LEAF/STEM EXTRACT . FURCELLARIA LUMBRICALIS EXTRACT . CI 15985/YELLOW 6 . POTASSIUM SORBATE . MARIS SAL/SEA SALT/SEL MARIN. [S3095A]
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.CLARINS - EXTRA-FIRMING JOUR SPF 15 - Wrinkle, Firming Day all skin types - Broad Spectrum SPF 15 Sunscreen AVOBENZONE, HOMOSALATE, OCTOCRYLENE WATER GLYCERIN BUTYLOCTYL SALICYLATE SHEA BUTTER DIMETHICONE ALKYL (C12-15) BENZOATE CETOSTEARYL ALCOHOL POTASSIUM CETYL PHOSPHATE CETEARYL GLUCOSIDE PHENOXYETHANOL BUTYLENE GLYCOL CAPRYLYL GLYCOL TROMETHAMINE OAT EDETATE DISODIUM ANHYDROUS .ALPHA.-TOCOPHEROL ACETATE XANTHAN GUM TOCOPHEROL MEDIUM-CHAIN TRIGLYCERIDES BETAINE SILICON DIOXIDE SORBITOL DIOSPYROS MESPILIFORMIS LEAF MALTODEXTRIN SODIUM BENZOATE KALANCHOE PINNATA LEAF BALANITES ROXBURGHII SEED OIL CITRIC ACID MONOHYDRATE MALPIGHIA EMARGINATA SEED LAPSANA COMMUNIS FLOWERING TOP FURCELLERAN FD&C YELLOW NO. 6 POTASSIUM SORBATE SEA SALT AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE
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 me dical 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 me dical 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