Sheer Broad Spectrum Spf45

Zinc Oxide, Octocrylene, Octinoxate, Octisalate


Vivier Pharma Inc.
Human Otc Drug
NDC 67226-2845
Sheer Broad Spectrum Spf45 also known as Zinc Oxide, Octocrylene, Octinoxate, Octisalate is a human otc drug labeled by 'Vivier Pharma Inc.'. National Drug Code (NDC) number for Sheer Broad Spectrum Spf45 is 67226-2845. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Sheer Broad Spectrum Spf45 drug includes Octinoxate - 75 mg/mL Octisalate - 50 mg/mL Octocrylene - 80 mg/mL Zinc Oxide - 99 mg/mL . The currest status of Sheer Broad Spectrum Spf45 drug is Active.

Drug Information:

Drug NDC: 67226-2845
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: Sheer Broad Spectrum Spf45
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: Zinc Oxide, Octocrylene, Octinoxate, Octisalate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Vivier Pharma Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Lotion
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:OCTINOXATE - 75 mg/mL
OCTISALATE - 50 mg/mL
OCTOCRYLENE - 80 mg/mL
ZINC OXIDE - 99 mg/mL
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: 14 May, 2015
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 28 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:Vivier Pharma 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:0696163891250
UPC stands for Universal Product Code.
UNII:4Y5P7MUD51
4X49Y0596W
5A68WGF6WM
SOI2LOH54Z
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.
Pharmacologic Class:Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
67226-2845-2250 mL in 1 TUBE (67226-2845-2)14 May, 2015N/ANo
67226-2845-91 BOTTLE in 1 CARTON (67226-2845-9) / 90 mL in 1 BOTTLE14 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:

Purpose sunscreen

Product Elements:

Sheer broad spectrum spf45 zinc oxide, octocrylene, octinoxate, octisalate polyoxyl 20 cetostearyl ether cetostearyl alcohol cyclomethicone 5 cyclomethicone 4 ethylparaben methylparaben phenoxyethanol phenyl trimethicone docosanol butylparaben alkyl (c12-15) benzoate propylparaben silicon dioxide edetate sodium .alpha.-tocopherol acetate triethoxycaprylylsilane water zinc oxide zinc cation octocrylene octocrylene octinoxate octinoxate octisalate octisalate

Indications and Usage:

Uses • helps prevent sunburn and provides a sun protection factor of 45. • ideal for daily use; can be applied under makeup.

Warnings:

For external use only • the sun may cause sunburn, premature aging of the skin and skin cancer. avoiding the sun, wearing protective clothing and regular use of sunscreens over the years may reduce the chance of these harmful effects. when using this product • avoid contact with eyes. if contact occurs, rinse thoroughly with water. • do not use on damaged or broken skin. stop use and ask a doctor if • rash or irritation develops and lasts. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

When Using:

When using this product • avoid contact with eyes. if contact occurs, rinse thoroughly with water. • do not use on damaged or broken skin.

Dosage and Administration:

Directions • apply daily to face, neck and chest. • apply liberally and evenly 15 minutes before sun exposure. • reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing. • for use on children less than 6 months of age, consult a healthcare practitioner. • use a water resistant sunscreen if swimming or sweating.

Stop Use:

Stop use and ask a doctor if • rash or irritation develops and lasts.

Package Label Principal Display Panel:

Product labels bottle carton

250ml packaging 250ml package label

Further Questions:

Questions? 450 455 9779 1 877 484 8437


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.