NDC 13537-402 Lbel Uv Defense 365

Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, And Zinc Oxide

NDC Product Code 13537-402

NDC Code: 13537-402

Proprietary Name: Lbel Uv Defense 365 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: Homosalate, Octinoxate, Octisalate, Oxybenzone, Titanium Dioxide, And Zinc Oxide 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

  • 13537 - Ventura Corporation Ltd. (san Juan, P.r)
    • 13537-402 - Lbel Uv Defense 365

NDC 13537-402-02

Package Description: 1 BOTTLE in 1 BOX > 30 mL in 1 BOTTLE (13537-402-01)

NDC 13537-402-04

Package Description: 1 BOTTLE in 1 BOX > 3 mL in 1 BOTTLE (13537-402-03)

NDC 13537-402-05

Package Description: 1 mL in 1 PACKET

NDC Product Information

Lbel Uv Defense 365 with NDC 13537-402 is a a human over the counter drug product labeled by Ventura Corporation Ltd. (san Juan, P.r). The generic name of Lbel Uv Defense 365 is homosalate, octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Ventura Corporation Ltd. (san Juan, P.r)

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.

Lbel Uv Defense 365 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.

  • HOMOSALATE .05 g/mL
  • OCTINOXATE .07 g/mL
  • OCTISALATE .05 g/mL
  • OXYBENZONE .04 g/mL
  • TITANIUM DIOXIDE .0624 g/mL
  • ZINC OXIDE .0388 g/mL

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)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARETH-12 (UNII: 7V4MR24V5P)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • AMBROSIA PERUVIANA LEAF (UNII: 458F79CGBF)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • MICA (UNII: V8A1AW0880)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • SUNFLOWER SEED (UNII: R9N3379M4Z)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • HEDERA HELIX TOP (UNII: 379040L9FW)
  • PHYTIC ACID (UNII: 7IGF0S7R8I)

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: Ventura Corporation Ltd. (san Juan, P.r)
Labeler Code: 13537
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: 08-29-2011 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: 12-31-2017 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: E 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.

Lbel Uv Defense 365 Product Label Images

Lbel Uv Defense 365 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

Other

Drug Facts

Dist. by Ventura Corporation, Ltd, San Juan, Puerto Rico 00926.

Otc - Purpose

Active IngredientsPurposeHomosalate (5 %)SunscreenOctinoxate (7 %)SunscreenOctisalate (5 %)Sunscreen Oxybenzone (4 %)SunscreenTitanium Dioxide (6.24%)SunscreenZinc Oxide (3.88%)Sunscreen

Uses

  • Helps prevent sunburn.higher SPF gives more sunburn protection

Warnings

  • For external use only.

Otc - When Using

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

Otc - Stop Use

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

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 smoothly every morning before sun exposure and as needed.

Other Information

  • High sun protection product.Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the sun.Apply the product with your fingertips. Use every morning before exposure to UVA and UVB radiation or whenever needed.

Inactive Ingredients

Aqua (water), dicaprylyl carbonate, propylheptyl caprylate, glyceryl stearate, potassium cetyl phosphate, alcohol denat., cyclohexasiloxane, polymethylsilsesquioxane, glycerin, sorbitan stearate, bis-ethylhexyl hydroxydimethoxy benzylmalonate, dimethicone, tocopheryl acetate, ceteareth-20, silica, methicone, cetearyl alcohol, ceteareth-12, cetyl palmitate, peg-8, propylene glycol, phenoxyethanol, methylparaben, ambrosia peruviana leaf extract, xantham gum, caprylyl glycol, mica, propylparaben, triethoxycaprylylsilane, butylene glycol, helianthus annuus (sunflower) seed extract, ppg-1-peg-9-lauryl glycol ether, chlorphenesin, cyclopentasiloxane, hedera helix (ivy) leaf/stem extract, phytic acid, sodium polyacrylate.

* Please review the disclaimer below.

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