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| Product NDC Code | 49967-899 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | La roche posay laboratoire dermatologique anthelios 50 tinted mineral sunscreen |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | L'Oreal USA Products Inc | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Titanium dioxide 11%
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: - shake well before use - apply generously 15 minutes before sun exposure - reapply: - after 40 minutes of swimming or sweating - immediately after towel drying - at least every 2 hours 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 a Broad Spectrum SPF value of 15 or higher and other sun protection meausures including: - limit time in the sun, especially from 10 a.m. - 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, isododecane, C12-15 alkyl benzoate, dimethicone, undecane, triethylhexanoin, isohexadecane, styrene/acrylates copolymer, nylon-12, caprylyl methicone, butyloctyl salicylate, phenethyl benzoate, silica, tridecane, dicaprylyl carbonate, dicaprylyl ether, talc, dimethicone/PEG-10/15 crosspolymer, aluminum stearate, pentylene glycol, C9-15 fluoroalcohol phosphate, tocopherol, phenoxyethanol, stearic acid, diethylhexyl syringylidenemalonate, PEG-9 polydimethylsiloxyethyl dimethcone, magnesium sulfate, PEG-8 laurate, PEG-9, polyhydroxystearic acid, maltodextrin, benzoic acid, iron oxides, propylene glycol, propylene carbonate, caprylyl glycol, disteardimonim hectorite, cassia alata leaf extract, alumina, aluminum hydroxide
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.La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Sunscreen Titanium Dioxide Titanium Dioxide Titanium Dioxide WATER ISODODECANE ALKYL (C12-15) BENZOATE DIMETHICONE UNDECANE TRIETHYLHEXANOIN ISOHEXADECANE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) NYLON-12 CAPRYLYL TRISILOXANE BUTYLOCTYL SALICYLATE PHENETHYL BENZOATE SILICON DIOXIDE TRIDECANE DICAPRYLYL CARBONATE DICAPRYLYL ETHER TALC ALUMINUM STEARATE PENTYLENE GLYCOL TOCOPHEROL PHENOXYETHANOL STEARIC ACID DIETHYLHEXYL SYRINGYLIDENEMALONATE PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE MAGNESIUM SULFATE, UNSPECIFIED FORM PEG-8 LAURATE POLYHYDROXYSTEARIC ACID (2300 MW) MALTODEXTRIN BENZOIC ACID PROPYLENE GLYCOL PROPYLENE CARBONATE CAPRYLYL GLYCOL DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE
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.image of a carton
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.
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? 1-888-577-5226 1-888-LRP LABO Monday - Friday (9 a.m. - 5 p.m. EST)
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information protect the product in this container from excessive heat and direct sun
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