NDC 14783-965 Lbel Defense Total Broad Spectrum Spf 50 Plus Sunscreen For Face And Body

Avobenzone, Homosalate, And Octocrylene

NDC Product Code 14783-965

NDC CODE: 14783-965

Proprietary Name: Lbel Defense Total Broad Spectrum Spf 50 Plus Sunscreen For Face And Body 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, And 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

NDC 14783-965-01

Package Description: 120 mL in 1 BOTTLE, PLASTIC

NDC 14783-965-02

Package Description: 80 mL in 1 BOTTLE, PLASTIC

NDC 14783-965-04

Package Description: 1 TUBE in 1 BOX > 10 mL in 1 TUBE (14783-965-03)

NDC 14783-965-05

Package Description: 5 mL in 1 PACKET

NDC 14783-965-06

Package Description: 1 mL in 1 PACKET

NDC 14783-965-08

Package Description: 1 PACKET in 1 CARTON > .07 mL in 1 PACKET (14783-965-07)

NDC Product Information

Lbel Defense Total Broad Spectrum Spf 50 Plus Sunscreen For Face And Body with NDC 14783-965 is a a human over the counter drug product labeled by Ventura International Ltd. The generic name of Lbel Defense Total Broad Spectrum Spf 50 Plus Sunscreen For Face And Body is avobenzone, homosalate, and octocrylene. The product's dosage form is lotion and is administered via topical form.

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 Defense Total Broad Spectrum Spf 50 Plus Sunscreen For Face And Body 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.


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)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
  • PHENETHYL BENZOATE (UNII: 0C143929GK)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
  • PHYSALIS ANGULATA (UNII: W4TKW9D5GG)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • OXOTHIAZOLIDINE (UNII: M6U1ZG59XD)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)

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 International Ltd
Labeler Code: 14783
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-18-2016 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 - NO 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".

* Please review the disclaimer below.

Lbel Defense Total Broad Spectrum Spf 50 Plus Sunscreen For Face And Body Product Label Images

Lbel Defense Total Broad Spectrum Spf 50 Plus Sunscreen For Face And Body 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 Int Ltd. DBA Belcorp USA, Miami, FL 33126

Otc - Purpose

Active IngredientsPurposeAVOBENZONE 3.00%SunscreenHOMOSALATE 10.00%SunscreenOCTOCRYLENE 8.00%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.

Otc - Do Not Use

  • Do not use on damaged or broken skin.

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 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 liberally and evenly 15 minutes before sun exposure.Reapply: after 40 [or 80] minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursChildren under 6 months of age: Ask a doctorSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.–2 p.m.wear long-sleeved shirts, pants, hats, and sunglasses.

Other Information

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

Inactive Ingredients

WATER, BUTYLOCTYL SALICYLATE, DIMETHICONE, POTASSIUM CETYL PHOSPHATE, POLYMETHYLSILSESQUIOXANE, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, ETHYLHEXYL METHOXYCRYLENE, PHENETHYL BENZOATE, PROPYLENE GLYCOL, VP/EICOSENE COPOLYMER, SILICA, TRIMETHYLSILOXYSILICATE, PHENOXYETHANOL, CETYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, FRAGRANCE, PHYSALIS ANGULATA EXTRACT, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETEARYL ALCOHOL, PENTAERYTHRITYL TETRA-DI-t-BUTYL HYDROXYHYDROCINNAMATE, XANTHAN GUM, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CAPRYLYL GLYCOL, DISODIUM EDTA, TOCOPHERYL ACETATE, BUTYLENE GLYCOL, CITRIC ACID, OXOTHIAZOLIDINE, d-LIMONENE, LINALOOL, CITRONELLOL.

* Please review the disclaimer below.