NDC 76147-232 Strivectin Advanced Spf Full Screen Illuminating

Avobenzone, Homosalate, Octisalate, Octocrylene

  1. Labeler Index
  2. Strivectin Operating Company, Inc.
  3. NDC: 76147-232 Strivectin Advanced Spf Full Screen Illuminating

NDC Product Code 76147-232

NDC CODE: 76147-232

Proprietary Name: Strivectin Advanced Spf Full Screen Illuminating 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.
Non-Proprietary Name: Avobenzone, Homosalate, Octisalate, Octocrylene 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.

NDC Code Structure

  • 76147 - Strivectin Operating Company, Inc.
    • 76147-232 - Strivectin Advanced Spf Full Screen

NDC 76147-232-11

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

NDC Product Information

Strivectin Advanced Spf Full Screen Illuminating with NDC 76147-232 is a 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.

Labeler Name: Strivectin Operating Company, Inc.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug 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.

Strivectin Advanced Spf Full Screen Illuminating Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
  • AVOBENZONE 3 g/100mL
  • HOMOSALATE 7 g/100mL
  • OCTISALATE 4.5 g/100mL
  • OCTOCRYLENE 10 g/100mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • MICA (UNII: V8A1AW0880)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • DIISOBUTYL ADIPATE (UNII: 8OPY05ZY7S)
  • POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MYRISTYL NICOTINATE (UNII: 8QWM6I035C)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ETHYLHEXYL OLEATE (UNII: R34927QY59)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • CANOLA OIL (UNII: 331KBJ17RK)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • BUTYL ACETATE (UNII: 464P5N1905)
  • SODIUM ACRYLATE (UNII: 7C98FKB43H)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • QUERCUS SUBER BARK (UNII: 8R5219271Q)
  • POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX)
  • LICORICE (UNII: 61ZBX54883)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • QUERCUS SPP. WHOLE (UNII: MF4E5I2OUQ)
  • ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • 7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • CITRAL (UNII: T7EU0O9VPP)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • STANNIC OXIDE (UNII: KM7N50LOS6)

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.

Labeler Name: Strivectin Operating Company, Inc.
Labeler Code: 76147
FDA Application Number: part352 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.
Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.
Start Marketing Date: 12-04-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date: 12-31-2021 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.
Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Strivectin Advanced Spf Full Screen Illuminating Product Label Images

Strivectin Advanced Spf Full Screen Illuminating Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

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

Purpose

Sunscreen

Uses

  • Helps prevent sunburnif 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 onlyDo not use on damaged or broken skinWhen 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 neededreapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 sunglasseschildren 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.