Tanning Sunscreen Uvb Protection Dry Oil Equate

Avobenzone, Homosalate, Octisalate


Wal-mart Stores Inc.
Human Otc Drug
NDC 79903-007
Tanning Sunscreen Uvb Protection Dry Oil Equate also known as Avobenzone, Homosalate, Octisalate is a human otc drug labeled by 'Wal-mart Stores Inc.'. National Drug Code (NDC) number for Tanning Sunscreen Uvb Protection Dry Oil Equate is 79903-007. This drug is available in dosage form of Aerosol, Spray. The names of the active, medicinal ingredients in Tanning Sunscreen Uvb Protection Dry Oil Equate drug includes Avobenzone - 20 mg/g Homosalate - 100 mg/g Octisalate - 50 mg/g . The currest status of Tanning Sunscreen Uvb Protection Dry Oil Equate drug is Active.

Drug Information:

Drug NDC: 79903-007
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: Tanning Sunscreen Uvb Protection Dry Oil Equate
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Tanning Sunscreen Uvb Protection Dry Oil
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: Equate
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: Avobenzone, Homosalate, Octisalate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Wal-mart Stores Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Aerosol, Spray
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 - 20 mg/g
HOMOSALATE - 100 mg/g
OCTISALATE - 50 mg/g
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 NOT 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: 31 Aug, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 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:WAL-MART STORES INC.
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.
UPC:0681131366960
UPC stands for Universal Product Code.
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
79903-007-37156 g in 1 CAN (79903-007-37)31 Aug, 2020N/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:

Purpose sunscreen

Product Elements:

Tanning sunscreen uvb protection dry oil equate avobenzone, homosalate, octisalate alcohol glycerin homosalate homosalate octisalate octisalate acrylate/isobutyl methacrylate/n-tert-octylacrylamide copolymer (75000 mw) light mineral oil avobenzone avobenzone tridecyl salicylate

Indications and Usage:

Uses • helps prevent sunburn • skin cancer/skin aging alert: spending time in the sun increases your risk of skin cancer and early signs of aging. this product has been shown only to prevent sunburn, not skin cancer or early skin aging.

Warnings:

Warnings for external use only flammable: • do not use near heat, flame or while smoking • avoid long term storage above 104°f (40°c)

Do Not Use:

Warnings for external use only flammable: • do not use near heat, flame or while smoking • avoid long term storage above 104°f (40°c)

When Using:

When using this product • keep out of eyes. rinse with water to remove. • keep away from face to avoid breathing it. • do not puncture or incinerate. contents under pressure. • do not store at temperatures above 120°f.

Dosage and Administration:

Directions • spray liberally and spread evenly by hand 15 minutes before sun exposure • hold can 4-6 inches away from the skin to apply • do not spray directly into face. spray into hands then apply to face • do not apply in windy conditions • use in a well-ventilated area • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • children under 6 months of age: ask a doctor

Package Label Principal Display Panel:

Label equate tanning sunscreen uvb protection spf 15 spray dry oil 5.5 oz (156 g) ndc 79903-007-37 label eq36696a2


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.