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Product NDC Code | 68828-295 | ||||||||
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Drug Name | Sun face protector 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 | Jafra Cosmetics International | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Avobenzone 3%..............Sunscreen Homosalate 10%.............Sunscreen Octisalate 5%..................Sunscreen Octocrylene 10%.............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.apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours 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 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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arginine, Bisabolol, Cetyl Alcohol, Dicaprylyl Carbonate, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Panthenol, Phenoxyethanol, Polyester-8, Sambucus Nigra (Elderberry) Fruit Extract, Styrene/Acrylates Copolymer, Tocopheryl Acetate, VP/Eicosene Copolymer, Water/Aqua
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.Stop use and ask a doctor if rash occurs
Purpose
Information about the drug product’s indications for use.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.
Spl product data elements
Usually a list of ingredients in a drug product.Sun face protector sunscreen broad spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene LEVOMENOL CETYL ALCOHOL DICAPRYLYL CARBONATE ETHYLHEXYLGLYCERIN PEG-100 STEARATE PANTHENOL .ALPHA.-TOCOPHEROL ACETATE GLYCERYL MONOSTEARATE POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) ARGININE GLYCERIN CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) EUROPEAN ELDERBERRY VINYLPYRROLIDONE/EICOSENE COPOLYMER WATER PHENOXYETHANOL EDETATE DISODIUM ANHYDROUS OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE
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.JAFRA SUN 50+ face protector sunscreen broad spectrum SPF 50+ Water Resistant (40 Minutes) 50 ml e 1.7 FL OZ (US) SUNN Face Protector 50
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 rigth away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.protect this product 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.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.
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