Jafra Royal Defy Sample Kit
Avobenzone, Homosalate, Octisalate, Octocrylene
Jafra Cosmetics International
Human Otc Drug
NDC 68828-760Jafra Royal Defy Sample Kit also known as Avobenzone, Homosalate, Octisalate, Octocrylene is a human otc drug labeled by 'Jafra Cosmetics International'. National Drug Code (NDC) number for Jafra Royal Defy Sample Kit is 68828-760. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Jafra Royal Defy Sample Kit drug includes . The currest status of Jafra Royal Defy Sample Kit drug is Active.
Drug Information:
| Drug NDC: | 68828-760 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Jafra Royal Defy Sample Kit |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Avobenzone, Homosalate, Octisalate, Octocrylene |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Jafra Cosmetics International |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 12 Jan, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | part352 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Jafra cosmetics International
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | G63QQF2NOX
V06SV4M95S
4X49Y0596W
5A68WGF6WM
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 68828-760-01 | 1 KIT in 1 KIT (68828-760-01) * 7.5 mL in 1 TUBE * 7.5 mL in 1 TUBE * 7.5 mL in 1 TUBE (68828-761-01) * 7.5 mL in 1 TUBE | 13 Jan, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose sunscreen
Product Elements:
Jafra royal defy sample kit avobenzone, homosalate, octisalate, octocrylene active firming serum water dimethicone dimethicone/vinyl dimethicone crosspolymer (soft particle) butylene glycol polysorbate 20 bis-peg-18 methyl ether dimethyl silane lauryl peg-9 polydimethylsiloxyethyl dimethicone .alpha.-tocopherol acetate silicon dioxide polymethylsilsesquioxane (4.5 microns) glycerin royal jelly medium-chain triglycerides tocopherol lecithin, soybean dipropylene glycol hydrogenated soybean lecithin shea butter methyl gluceth-20 dimethyl isosorbide acetyl tetrapeptide-11 acetyl tetrapeptide-9 phenoxyethanol caffeine niacinamide ethylhexylglycerin caprylyl glycol sodium pyrrolidone carboxylate carbomer homopolymer type b (allyl pentaerythritol or allyl sucrose crosslinked) hyaluronic acid xanthan gum phenylethyl alcohol maltodextrin edetate disodium citric acid monohydrate soybean ceramide np sodium benzoate potassium sorbate avocado oil olive oil benzyl salicylate limonene, (+)- hydroxycitronellal linalool, (+/-)- butylphenyl methylpropional 4d defining hydrator water glycerin xylitol xylitylglucoside anhydroxylitol octyldodecanol octyldodecyl xyloside peg-30 dipolyhydroxystearate (4000 mw) ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) ethylhexyl palmitate chondrus crispus carrageenan caffeine dextran 40 trifluoroacetyl tripeptide-2 hyaluronate sodium sodium pyrrolidone carboxylate .alpha.-tocopherol acetate isosorbide dicaprylate soybean ceramide np avocado oil olive oil phenoxyethanol caprylyl glycol potassium sorbate hexylene glycol mangifera indica seed butter jojoba oil ceramide ng palmitoyl hexapeptide-12 alkyl (c12-15) benzoate tribehenin medium-chain triglycerides royal jelly tocopherol hydrogenated soybean lecithin shea butter phenylethyl alcohol ethylhexylglycerin maltodextrin lecithin, soybean dipropylene glycol sodium benzoate benzyl salicylate limonene, (+)- hydroxycitronellal linalool, (+/-)- butylphenyl methylpropional rich creme cleanser water alkyl (c12-15) benzoate glycerin dimethicone medium-chain triglycerides glyceryl monostearate peg-100 stearate shea butter stearyl heptanoate stearyl caprylate cetyl alcohol hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) isohexadecane polysorbate 60 sorbitan isostearate phenoxyethanol ethylhexylglycerin hydrogenated soybean lecithin caprylyl glycol xanthan gum .alpha.-tocopherol acetate sodium pyrrolidone carboxylate edetate disodium hyaluronate sodium royal jelly phenylethyl alcohol maltodextrin lecithin, soybean dipropylene glycol tocopherol avocado oil olive oil soybean ceramide np sodium benzoate potassium sorbate royal defy multi-performance age protector broad spectrum spf 50 avobenzone, homosalate, octisalate, octocrylene styrene/acrylamide copolymer (500000 mw) sucrose stearate ceric oxide aluminum oxide vinylpyrrolidone/eicosene copolymer glycerin ethylhexylglycerin ethylhexyl methoxycrylene butyloctyl salicylate phenylethyl alcohol polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) ceramide np butylene glycol polysorbate 60 phenoxyethanol dipropylene glycol potassium sorbate hydrogenated soybean lecithin avocado oil poly(methyl methacrylate; 450000 mw) water cocoa glyceryl monostearate peg-100 stearate hexylene glycol hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) lecithin, soybean maltodextrin squalane tocopherol xanthan gum medium-chain triglycerides caprylyl glycol hyaluronate sodium soybean sodium benzoate royal jelly sodium pyrrolidone carboxylate pyrrolidone carboxylic acid .alpha.-tocopherol acetate shea butter olive oil avobenzone avobenzone homosalate homosalate octisalate octisalate octocrylene octocrylene royal defy multi-performance age protector broad spectrum spf 50 avobenzone, homosalate, octisalate, octocrylene aluminum oxide butylene glycol butyloctyl salicylate shea butter medium-chain triglycerides caprylyl glycol ceramide np ceric oxide dipropylene glycol ethylhexyl methoxycrylene ethylhexylglycerin glycerin glyceryl monostearate soybean hexylene glycol hydrogenated soybean lecithin hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) lecithin, soybean maltodextrin olive oil peg-100 stearate avocado oil phenylethyl alcohol phenoxyethanol polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) poly(methyl methacrylate; 450000 mw) polysorbate 60 potassium sorbate royal jelly sodium benzoate hyaluronate sodium sodium pyrrolidone carboxylate squalane styrene/acrylamide copolymer (500000 mw) sucrose stearate cocoa tocopherol .alpha.-tocopherol acetate vinylpyrrolidone/eicosene copolymer water xanthan gum avobenzone avobenzone homosalate homosalate octisalate octisalate octocrylene octocrylene jafra royal defy travel kit avobenzone, homosalate, octisalate, octocrylene active firming serum phenoxyethanol caffeine niacinamide ethylhexylglycerin caprylyl glycol sodium pyrrolidone carboxylate carbomer homopolymer type b (allyl pentaerythritol or allyl sucrose crosslinked) hyaluronic acid xanthan gum phenylethyl alcohol maltodextrin edetate disodium citric acid monohydrate soybean ceramide np sodium benzoate potassium sorbate avocado oil olive oil benzyl salicylate limonene, (+)- hydroxycitronellal linalool, (+/-)- butylphenyl methylpropional water dimethicone dimethicone/vinyl dimethicone crosspolymer (soft particle) butylene glycol polysorbate 20 bis-peg-18 methyl ether dimethyl silane lauryl peg-9 polydimethylsiloxyethyl dimethicone .alpha.-tocopherol acetate silicon dioxide polymethylsilsesquioxane (4.5 microns) glycerin royal jelly medium-chain triglycerides tocopherol lecithin, soybean dipropylene glycol hydrogenated soybean lecithin shea butter methyl gluceth-20 dimethyl isosorbide acetyl tetrapeptide-11 acetyl tetrapeptide-9 4d defining hydrator water glycerin xylitol xylitylglucoside anhydroxylitol octyldodecanol octyldodecyl xyloside peg-30 dipolyhydroxystearate (4000 mw) ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) ethylhexyl palmitate chondrus crispus carrageenan caffeine dextran 40 trifluoroacetyl tripeptide-2 hyaluronate sodium sodium pyrrolidone carboxylate .alpha.-tocopherol acetate isosorbide dicaprylate soybean ceramide np avocado oil olive oil phenoxyethanol caprylyl glycol potassium sorbate hexylene glycol mangifera indica seed butter jojoba oil ceramide ng palmitoyl hexapeptide-12 alkyl (c12-15) benzoate tribehenin medium-chain triglycerides royal jelly tocopherol hydrogenated soybean lecithin shea butter phenylethyl alcohol ethylhexylglycerin maltodextrin lecithin, soybean dipropylene glycol sodium benzoate benzyl salicylate limonene, (+)- hydroxycitronellal linalool, (+/-)- butylphenyl methylpropional rich creme cleanser water alkyl (c12-15) benzoate glycerin dimethicone medium-chain triglycerides glyceryl monostearate peg-100 stearate shea butter stearyl heptanoate stearyl caprylate cetyl alcohol hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) isohexadecane polysorbate 60 sorbitan isostearate phenoxyethanol ethylhexylglycerin hydrogenated soybean lecithin caprylyl glycol xanthan gum .alpha.-tocopherol acetate sodium pyrrolidone carboxylate edetate disodium hyaluronate sodium royal jelly phenylethyl alcohol maltodextrin lecithin, soybean dipropylene glycol tocopherol avocado oil olive oil soybean ceramide np sodium benzoate potassium sorbate royal defy age and pollution protector broad spectrum spf 50 avobenzone, homosalate, octisalate, octocrylene styrene/acrylamide copolymer (500000 mw) sucrose stearate ceric oxide aluminum oxide vinylpyrrolidone/eicosene copolymer glycerin ethylhexylglycerin ethylhexyl methoxycrylene butyloctyl salicylate phenylethyl alcohol polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) ceramide np butylene glycol polysorbate 60 phenoxyethanol dipropylene glycol potassium sorbate hydrogenated soybean lecithin avocado oil poly(methyl methacrylate; 450000 mw) water cocoa glyceryl monostearate peg-100 stearate hexylene glycol hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (100000 mpa.s at 1.5%) lecithin, soybean maltodextrin squalane tocopherol xanthan gum medium-chain triglycerides caprylyl glycol hyaluronate sodium soybean sodium benzoate royal jelly sodium pyrrolidone carboxylate pyrrolidone carboxylic acid .alpha.-tocopherol acetate shea butter olive oil avobenzone avobenzone homosalate homosalate octisalate octisalate octocrylene octocrylene
Indications and Usage:
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.
Warnings:
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
Dosage and Administration:
Directions apply generously and evenly 15 minutes before sun exposure use a water-resistant sunscreen if swimming or sweating reapply at least every 2 hours. children under 6 months of age: 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 your time in the sun, especially from 10 a.m. 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses
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