NDC 76147-232 Strivectin Advanced Spf Full Screen Illuminating
Avobenzone, Homosalate, Octisalate, Octocrylene Lotion Topical

Product Information

What is NDC 76147-232?

The NDC code 76147-232 is assigned by the FDA to the product Strivectin Advanced Spf Full Screen Illuminating which is a human over the counter drug product labeled by Strivectin Operating Company, Inc.. The generic name of Strivectin Advanced Spf Full Screen Illuminating is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is lotion and is administered via topical form. The product is distributed in a single package with assigned NDC code 76147-232-11 1 tube in 1 box / 44 ml in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code76147-232
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Strivectin Advanced Spf Full Screen Illuminating
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Avobenzone, Homosalate, Octisalate, Octocrylene
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
Human Otc Drug
Dosage FormLotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Strivectin Operating Company, Inc.
Labeler Code76147
FDA Application Number What is the FDA Application Number?
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.
part352
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
12-04-2019
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.
12-31-2023
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
N
NDC Code Structure

What are the uses for Strivectin Advanced Spf Full Screen Illuminating?


Product Packages

NDC Code 76147-232-11

Package Description: 1 TUBE in 1 BOX / 44 mL in 1 TUBE

Product Details

What are Strivectin Advanced Spf Full Screen Illuminating Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Strivectin Advanced Spf Full Screen Illuminating Active Ingredients UNII Codes

Strivectin Advanced Spf Full Screen Illuminating Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Strivectin Advanced Spf Full Screen Illuminating Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredients



Avobenzone 3.0%
Homosalate 7.0%
Octisalate 4.5%
Octocrylene 10%


Purpose



Sunscreen


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



  • 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

Otc - Keep Out Of Reach Of Children



  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions



  • Apply generously 15 minutes before sun exposure and as needed
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time inthe sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protectionmeasures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats,and sunglasses
  • children under 6 months of age: ask a doctor

Other Information



Protect the product in this container from excessive heat and direct sun.


Inactive Ingredients



Aqua (Water, Eau), Glycerin, Butyloctyl Salicylate, Mica, Dimethicone, Titanium Dioxide, Diisobutyl Adipate, Polymethylsilsesquioxane/Silica Crosspolymer, Acrylates/Dimethicone Copolymer, Fragrance (Parfum), Myristyl Nicotinate, Argania Spinosa (Argan) Kernel Oil, Cocos Nucifera (Coconut) Oil, Ethylhexyl Olivate, Glycine Soja (Soybean) Oil, Brassica Campestris (Rapeseed) Seed Oil, Polysilicone-11, Caprylyl Glycol, Tocopherol, Bis(Cyano Butylacetate) Anthracenediylidene, Sodium Acrylates Copolymer, Phenoxyethanol, Polyglyceryl-3 Diisostearate, Quercus Suber Bark Extract, Polyglyceryl-4 Olivate, Glycyrrhiza Glabra (Licorice) Root Extract, Hexylene Glycol, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Disodium EDTA, Oak Root Extract, Althaea Officinalis Root Extract, Oryza Sativa (Rice) Bran Extract, Retinyl Palmitate, 7-Dehydrocholesterol, Ascorbyl Palmitate, Limonene, Citral, Linalool, Tin Oxide


* Please review the disclaimer below.