Beauty Before Age Ahava Uplift Day Broad Spectrum Spf 20

Homosalate, Octisalate, And Avobenzone


Ahava Dead Sea Laboratories Ltd
Human Otc Drug
NDC 60289-283
Beauty Before Age Ahava Uplift Day Broad Spectrum Spf 20 also known as Homosalate, Octisalate, And Avobenzone is a human otc drug labeled by 'Ahava Dead Sea Laboratories Ltd'. National Drug Code (NDC) number for Beauty Before Age Ahava Uplift Day Broad Spectrum Spf 20 is 60289-283. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Beauty Before Age Ahava Uplift Day Broad Spectrum Spf 20 drug includes Avobenzone - 1.5 g/50mL Homosalate - 3.5 g/50mL Octisalate - 2.5 g/50mL . The currest status of Beauty Before Age Ahava Uplift Day Broad Spectrum Spf 20 drug is Active.

Drug Information:

Drug NDC: 60289-283
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: Beauty Before Age Ahava Uplift Day Broad Spectrum Spf 20
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Beauty Before Age
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: AHAVA UPLIFT DAY broad spectrum SPF 20
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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: Homosalate, Octisalate, And Avobenzone
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Ahava Dead Sea Laboratories Ltd
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Cream
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:AVOBENZONE - 1.5 g/50mL
HOMOSALATE - 3.5 g/50mL
OCTISALATE - 2.5 g/50mL
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: 15 May, 2015
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 26 Dec, 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:AHAVA Dead Sea Laboratories Ltd
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
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
60289-283-241 JAR in 1 CARTON (60289-283-24) / 50 mL in 1 JAR15 May, 2015N/ANo
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:

Active ingredients purpose avobenzone [3%] sunscreens homosalate [7%] sunscreens octisalate [5%] sunscreens

Product Elements:

Beauty before age ahava uplift day broad spectrum spf 20 homosalate, octisalate, and avobenzone homosalate homosalate octisalate octisalate avobenzone avobenzone water butyloctyl salicylate butylene glycol acetyl tyrosylarginine cetyl ester sorbitan monolaurate cyclomethicone 5 propanediol octyldodecyl neopentanoate glyceryl monostearate peg-100 stearate trehalose myristyl myristate glycerin palmitoyl lysyldioxymethionyllysine flax seed ethylhexylglycerin phenoxyethanol aloe vera leaf mentha piperita leaf dimethicone silicon dioxide allantoin propylene glycol chamomile xanthan gum .alpha.-tocopherol acetate benzotriazolyl dodecyl p-cresol .alpha.-tocopherol benzyl salicylate .alpha.-hexylcinnamaldehyde linalool, (+/-)- .beta.-citronellol, (r)- hydroxycitronellal polyester-8 (1400 mw, cyanodiphenylpropenoyl capped) cetostearyl alcohol butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) glycol stearate sorbitan tristearate peg-40 stearate polyoxyl 20 cetostearyl ether hydroxyethyl cellulose (4000 mpa.s at 1%) hydroxypropyl .alpha.-cyclodextrin methyl methacrylate/glycol dimethacrylate crosspolymer limonene, (-)- sodium benzoate potassium sorbate sunflower oil ledikite benzyl benzoate isomethyl-.alpha.-ionone

Indications and Usage:

Uses helps prevent sunburn

Warnings:

Warnings for external use only when using this product keep out of eyes. rinse with water to remove stop use and consult a doctor if rash or irritation develops and lasts do not use on damaged or broken skin keep out of reach of children. if swallowed, get medical attention or contact a poison control center right away

Do Not Use:

Warnings for external use only when using this product keep out of eyes. rinse with water to remove stop use and consult a doctor if rash or irritation develops and lasts do not use on damaged or broken skin keep out of reach of children. if swallowed, get medical attention or contact a poison control center right away

When Using:

When using this product keep out of eyes. rinse with water to remove

Dosage and Administration:

Directions apply liberally and evenly to clean face 15 minutes before sun exposure apply daily for a clearer, brighter complexion 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 broad spectrum spf value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m.-2 p.m. wear long-sleeved shirts, pants, hats and sunglasses

Stop Use:

Stop use and consult a doctor if rash or irritation develops and lasts

Package Label Principal Display Panel:

Principal display panel - 50 ml jar carton ahava beauty before age uplift day cream broad spectrum spf20 50 ml ℮ 1.7 fl.oz principal display panel - 50 ml jar carton

Further Questions:

Questions or comments call toll free 1-800-366-7254


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.