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| Product NDC Code | 68828-757 |
|---|---|
| Drug Name | Jafra royal luna bright kit |
| Type | Brand |
| Dosage Form | KIT |
| Application Number | part352 |
| Labeler Name | JAFRA COSMETICS INTERNATIONAL INC |
| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient(s) Avobenzone 3% Homosalate 10% Octisalate 5% Octocrylene 7%
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 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 measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch Octenylsuccinate, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Arginine, Benzyl Alcohol, Bisabolol, Butyrospermum Parkii (Shea) Butter, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lauroyl Lysine, Hydrogenated Lecithin, Lecithin, Maltodextrin, PEG-100 Stearate, Palmaria Palmata (red seaweed) Extract, Phenoxyethanol, Phenethyl Alcohol, Polysorbate 60, Royal Jelly, Royal Jelly Powder, Silica, Sorbitan Isostearate, Styrene/Acrylates Copolymer, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Yeast Extract
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.Jafra Royal Luna Bright Kit Avobenzone, Homosalate, Octisalate, Octocrylene Refining Gel Cleanser WATER COCAMIDOPROPYL BETAINE DECYL GLUCOSIDE PEG-7 GLYCERYL COCOATE COCO GLUCOSIDE SODIUM LAUROYL SARCOSINATE GLYCERIN ROYAL JELLY HYDROGENATED SOYBEAN LECITHIN SHEA BUTTER PEG-150 PENTAERYTHRITYL TETRASTEARATE CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) GLYCOL STEARATE WINE GRAPE JUICE XANTHAN GUM POTASSIUM SORBATE TROLAMINE MICA BISMUTH OXYCHLORIDE PHENYLETHYL ALCOHOL ETHYLHEXYLGLYCERIN MALTODEXTRIN LECITHIN, SOYBEAN DIPROPYLENE GLYCOL PHENOXYETHANOL HYALURONATE SODIUM ISOMETHYL-.ALPHA.-IONONE BUTYLPHENYL METHYLPROPIONAL .BETA.-CITRONELLOL, (R)- .ALPHA.-HEXYLCINNAMALDEHYDE HYDROXYCITRONELLAL LIMONENE, (+)- LINALOOL, (+/-)- Brightening Hydrogel Moisturizer DISTEARDIMONIUM HECTORITE WATER GLYCERIN PALMARIA PALMATA CYCLOMETHICONE 5 SILICON DIOXIDE HYALURONATE SODIUM TREHALOSE SODIUM PYRROLIDONE CARBOXYLATE UREA TRIACETIN DIMETHICONE BIS-PEG-18 METHYL ETHER DIMETHYL SILANE ROYAL JELLY HYDROGENATED SOYBEAN LECITHIN SHEA BUTTER PHENOXYETHANOL CAPRYLYL GLYCOL ETHYLHEXYLGLYCERIN HEXYLENE GLYCOL CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) MEDIUM-CHAIN TRIGLYCERIDES HYDROXYETHYL UREA TROLAMINE PHENYLETHYL ALCOHOL MALTODEXTRIN LECITHIN, SOYBEAN DIPROPYLENE GLYCOL CYCLOMETHICONE 6 Brightening Serum Concentrate GLYCERIN WATER CAPRYLHYDROXAMIC ACID 1,2-HEXANEDIOL PROPANEDIOL SODIUM POLYACRYLATE (8000 MW) DIMETHICONE CYCLOMETHICONE 5 TRIDECETH-6 PEG/PPG-18/18 DIMETHICONE ROYAL JELLY HYDROGENATED SOYBEAN LECITHIN SHEA BUTTER PALMARIA PALMATA HYALURONATE SODIUM TREHALOSE SODIUM PYRROLIDONE CARBOXYLATE UREA TRIACETIN TOCOPHEROL EDETATE TRISODIUM PHENYLETHYL ALCOHOL ETHYLHEXYLGLYCERIN MALTODEXTRIN LECITHIN, SOYBEAN DIPROPYLENE GLYCOL PHENOXYETHANOL ISOMETHYL-.ALPHA.-IONONE BUTYLPHENYL METHYLPROPIONAL .BETA.-CITRONELLOL, (R)- .ALPHA.-HEXYLCINNAMALDEHYDE HYDROXYCITRONELLAL LIMONENE, (+)- LINALOOL, (+/-)- Luna Bright Brightening Daily Protector Broad Spectrum SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) LAUROYL LYSINE CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) ARACHIDYL ALCOHOL DOCOSANOL ARGININE LEVOMENOL SHEA BUTTER BUTYLENE GLYCOL CHLORPHENESIN ETHYLHEXYLGLYCERIN PHENOXYETHANOL ALLANTOIN, (+)- ALUMINUM STARCH OCTENYLSUCCINATE ARACHIDYL GLUCOSIDE BENZYL ALCOHOL CYCLOMETHICONE 5 EDETATE DISODIUM ISOHEXADECANE HYDROGENATED SOYBEAN LECITHIN LECITHIN, SOYBEAN MALTODEXTRIN PEG-100 STEARATE DULSE POLYSORBATE 60 ROYAL JELLY SILICON DIOXIDE PEG-20 SORBITAN ISOSTEARATE COCOA GLYCERYL MONOSTEARATE GLYCERIN WATER DIPROPYLENE GLYCOL PHENYLETHYL ALCOHOL AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE 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.Product label image description
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information 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.Warnings For external use only Do not use on damaged or broken skin Stop use and ask a doctor if rash occurs 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