Jafra Royal Defy Travel Kit
Avobenzone, Homosalate, Octisalate, Octocrylene
Jafra Cosmetics International
Human Otc Drug
NDC 68828-513Jafra Royal Defy Travel 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 Travel Kit is 68828-513. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Jafra Royal Defy Travel Kit drug includes . The currest status of Jafra Royal Defy Travel Kit drug is Active.
Drug Information:
| Drug NDC: | 68828-513 |
| 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 Travel 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: | 22 Aug, 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 |
|---|
| 68828-513-01 | 1 KIT in 1 KIT (68828-513-01) * 7.5 mL in 1 TUBE * 14 mL in 1 TUBE * 14 mL in 1 TUBE (68828-514-01) * 30 mL in 1 TUBE | 22 Aug, 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 gentle cleansing milk water cocamidopropyl betaine peg-7 glyceryl cocoate coco glucoside decyl glucoside styrene/acrylamide copolymer (500000 mw) sodium lauroyl sarcosinate glycol stearate phenoxyethanol sodium hydroxide allantoin edetate sodium benzoic acid dehydroacetic acid caprylyl glycol sodium ascorbyl phosphate glycerin polygonum aviculare top royal jelly shea butter dipropylene glycol lecithin, soybean hydrogenated soybean lecithin phenylethyl alcohol ethylhexylglycerin maltodextrin benzyl salicylate spot serum water octyldodecanol biosaccharide gum-1 sodium polyacrylate (2500000 mw) butylene glycol kiwi fruit oil dmdm hydantoin coconut edetate trisodium sodium ascorbyl phosphate moringa oleifera leaf alcohol sophora flavescens root lecithin, soybean phenoxyethanol shea butter iodopropynyl butylcarbamate dipropylene glycol garden cress sprout hydrogenated soybean lecithin phenylethyl alcohol royal jelly ethylhexylglycerin maltodextrin benzyl salicylate butylphenyl methylpropional hydroxycitronellal limonene, (+)- longevity creme water polyisobutylene (800000 mw) cetostearyl alcohol polyoxyl 20 cetostearyl ether isopropyl palmitate alkyl (c12-15) benzoate dimethicone pentylene glycol di-ppg-3 myristyl ether adipate stearyl stearate pentaerythrityl distearate royal jelly honey hydrogenated soybean lecithin shea butter sodium pyrrolidone carboxylate myristyl myristate palmitoyl glycine phenylethyl alcohol ethylhexylglycerin maltodextrin squalene coconut oil trolamine carbomer interpolymer type a (allyl sucrose crosslinked) edetate trisodium peg-4 laurate iodopropynyl butylcarbamate lecithin, soybean dipropylene glycol dmdm hydantoin vitamin a palmitate ascorbyl palmitate .alpha.-tocopherol acetate benzyl salicylate limonene, (+)- hydroxycitronellol butylphenyl methylpropional linalool, (+/-)- revitalize solar protection fluid broad spectrum spf 50 avobenzone, homosalate, octisalate, octocrylene carbomer interpolymer type a (allyl sucrose crosslinked) kiwi fruit oil alcohol allantoin aluminum starch octenylsuccinate arachidyl alcohol arachidyl glucoside arginine docosanol benzyl alcohol levomenol butylene glycol shea butter chlorphenesin coconut cyclomethicone 5 dipropylene glycol edetate disodium anhydrous ethylhexylglycerin glycerin glyceryl monostearate hydrogenated soybean lecithin lauroyl lysine lecithin, soybean maltodextrin moringa oleifera leaf peg-100 stearate phenylethyl alcohol polygonum aviculare top royal jelly sodium ascorbyl phosphate sophora flavescens root styrene/acrylamide copolymer (500000 mw) water benzyl salicylate butylphenyl methylpropional hydroxycitronellal limonene, (+)- linalool, (+/-)- avobenzone avobenzone homosalate homosalate octisalate octisalate octocrylene octocrylene revitalize solar protection fluid broad spectrum spf 50 avobenzone, homosalate, octisalate, octocrylene carbomer interpolymer type a (allyl sucrose crosslinked) kiwi fruit oil alcohol allantoin aluminum starch octenylsuccinate arachidyl alcohol arachidyl glucoside arginine docosanol benzyl alcohol levomenol butylene glycol shea butter chlorphenesin coconut cyclomethicone 5 dipropylene glycol edetate disodium anhydrous ethylhexylglycerin glycerin glyceryl monostearate hydrogenated soybean lecithin lauroyl lysine lecithin, soybean maltodextrin moringa oleifera leaf peg-100 stearate phenylethyl alcohol polygonum aviculare top royal jelly sodium ascorbyl phosphate sophora flavescens root styrene/acrylamide copolymer (500000 mw) water benzyl salicylate butylphenyl methylpropional hydroxycitronellal limonene, (+)- linalool, (+/-)- avobenzone avobenzone homosalate homosalate octisalate octisalate octocrylene octocrylene jafra royal defy travel kit avobenzone, homosalate, octisalate, octocrylene gentle cleansing milk water cocamidopropyl betaine peg-7 glyceryl cocoate coco glucoside decyl glucoside styrene/acrylamide copolymer (500000 mw) sodium lauroyl sarcosinate glycol stearate phenoxyethanol sodium hydroxide allantoin edetate sodium benzoic acid dehydroacetic acid caprylyl glycol sodium ascorbyl phosphate glycerin polygonum aviculare top royal jelly shea butter dipropylene glycol lecithin, soybean hydrogenated soybean lecithin phenylethyl alcohol ethylhexylglycerin maltodextrin benzyl salicylate spot serum water octyldodecanol biosaccharide gum-1 sodium polyacrylate (2500000 mw) butylene glycol royal jelly kiwi fruit oil dmdm hydantoin coconut edetate trisodium sodium ascorbyl phosphate moringa oleifera leaf alcohol sophora flavescens root lecithin, soybean phenoxyethanol shea butter iodopropynyl butylcarbamate dipropylene glycol garden cress sprout hydrogenated soybean lecithin phenylethyl alcohol ethylhexylglycerin maltodextrin benzyl salicylate butylphenyl methylpropional hydroxycitronellal limonene, (+)- longevity creme water polyisobutylene (800000 mw) cetostearyl alcohol polyoxyl 20 cetostearyl ether isopropyl palmitate alkyl (c12-15) benzoate dimethicone pentylene glycol di-ppg-3 myristyl ether adipate stearyl stearate pentaerythrityl distearate royal jelly honey hydrogenated soybean lecithin shea butter sodium pyrrolidone carboxylate myristyl myristate palmitoyl glycine phenylethyl alcohol ethylhexylglycerin maltodextrin squalene coconut oil trolamine carbomer interpolymer type a (allyl sucrose crosslinked) edetate trisodium peg-4 laurate iodopropynyl butylcarbamate lecithin, soybean dipropylene glycol dmdm hydantoin vitamin a palmitate ascorbyl palmitate .alpha.-tocopherol acetate benzyl salicylate limonene, (+)- hydroxycitronellol butylphenyl methylpropional linalool, (+/-)- revitalize solar protection fluid broad spectrum spf 50 avobenzone, homosalate, octisalate, octocrylene carbomer interpolymer type a (allyl sucrose crosslinked) kiwi fruit oil alcohol allantoin aluminum starch octenylsuccinate arachidyl alcohol arachidyl glucoside arginine docosanol benzyl alcohol levomenol butylene glycol shea butter chlorphenesin coconut cyclomethicone 5 dipropylene glycol edetate disodium anhydrous ethylhexylglycerin glycerin hydrogenated soybean lecithin lauroyl lysine lecithin, soybean maltodextrin moringa oleifera leaf peg-100 stearate phenylethyl alcohol polygonum aviculare top royal jelly sodium ascorbyl phosphate sophora flavescens root styrene/acrylamide copolymer (500000 mw) water benzyl salicylate butylphenyl methylpropional hydroxycitronellal limonene, (+)- linalool, (+/-)- glyceryl monostearate 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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