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Product NDC Code | 11090-099 | ||||||||
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Drug Name | Loreal paris revitalift derm intensives invisible uv fluid broad spectrum spf 50 sunscreen |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | GEL | ||||||||
Application Number | part352 | ||||||||
Labeler Name | Beauty Manufacturing Solutions Corp. | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Avobenzone 3% Homosalate 15% Octisalate 5% Octocrylene 10%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.water, alcohol denat.,glycerin, styrene/acrylates copolymer dimethicone, butyloctyl salicylate,silica, Isononyl Isononanoate,Isopropyl Myristate, Cetearyl Alcohol, Calcium Aluminum Borosilicate,Tocopherol,Adenosine,Phenyl Resorcinol,Trisodium Ethylenediamine Disuccinate,Ascorbyl Glucoside,isocetyl stearate,ammonium acryloyldimethyltaurate/vp copolymer,caprylyl glycol,carbomer,cetearyl glucoside, inulin lauryl carbamate,Lecithin,PEG-20,PEG-8 laurate,pullulan,sclerotium gum,sodium dodecylbenzenesulfonate, Sodium Stearoyl Glutamate,t-Butyl Alcohol,Xanthan Gum,Phenoxyethanol
Purpose
Information about the drug product’s indications for use.Avobenzone 3%-Sunscreen Homosalate 15%-Sunscreen Octisalate 5%-Sunscreen Octocrylene 10%-Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen Avobenzone, Homosalate, Octisalate, and Octocrylene HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE WATER ASCORBYL GLUCOSIDE POLYETHYLENE GLYCOL 1000 ADENOSINE ALCOHOL CAPRYLYL GLYCOL CALCIUM ALUMINUM BOROSILICATE BUTYLOCTYL SALICYLATE BETASIZOFIRAN PULLULAN SODIUM STEAROYL GLUTAMATE PHENYLETHYL RESORCINOL TRISODIUM ETHYLENEDIAMINE DISUCCINATE ISONONYL ISONONANOATE PHENOXYETHANOL SILICON DIOXIDE AVOBENZONE AVOBENZONE GLYCERIN ISOPROPYL MYRISTATE TERT-BUTYL ALCOHOL INULIN LAURYL CARBAMATE ISOCETYL ISOSTEARATE CETEARYL GLUCOSIDE OCTOCRYLENE OCTOCRYLENE .ALPHA.-TOCOPHEROL, DL- XANTHAN GUM CETOSTEARYL ALCOHOL DIMETHICONE
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.Principle Display Panel
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.on damaged or broken skin
Instructions for use
Information about safe handling and use of the drug product.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
DIRECTIONS For sunscreen use: shake well 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, 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. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months of age: Ask a doctor
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.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 protect the product in this container from excessive heat and direct sun
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.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.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.For external use only
FLAMMABLE UNTIL DRY. Do not use near fire, flame, or heat.
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