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Product NDC Code | 68828-294 | ||||||||
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Drug Name | Jafra sun body 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.Directions apply liberally and evenly 15 minutes before sun exposure Reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • 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.Inactive Ingredients Water, Polyester-8, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Ethylhexyl Methoxycrylene, Phenoxyethanol, Ethylhexylglycerin, Mica, Silica, Arginine, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance/Parfum, Disodium EDTA, Panthenol, Bisabolol, Sambucus Nigra (Elderberry) Fruit Extract, Benzyl Salicylate, Butylphenyl Methylpropional, Coumarin, Hydroxycitronellal, Linalool, Limonene
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
Spl product data elements
Usually a list of ingredients in a drug product.Jafra Sun body protector sunscreen broad spectrum SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene GLYCERYL MONOSTEARATE GLYCERIN ETHYLHEXYLGLYCERIN PHENOXYETHANOL POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) EUROPEAN ELDERBERRY .ALPHA.-TOCOPHEROL ACETATE VINYLPYRROLIDONE/EICOSENE COPOLYMER WATER CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) PEG-100 STEARATE PANTHENOL ARGININE CETYL ALCOHOL EDETATE DISODIUM ANHYDROUS MICA ETHYLHEXYL METHOXYCRYLENE STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) LEVOMENOL DICAPRYLYL CARBONATE BENZYL SALICYLATE BUTYLPHENYL METHYLPROPIONAL COUMARIN HYDROXYCITRONELLAL LIMONENE, (+)- LINALOOL, (+/-)- SILICON DIOXIDE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE
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.Product label image description
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.Other Information protect this product from excessive heat and direct sun
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Questions? Call 1-800-551-2345 or visit www.jafra.com
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