NDC 14783-119 Lederm Day Sunscreen Broad Spectrum Spf 15 Day Facial Spf 15 Against Noticeable Signs Of Aging All Skin Types

Avobenzone, Octisalate, Octocrylene, And Oxybenzone

NDC Product Code 14783-119

NDC CODE: 14783-119

Proprietary Name: Lederm Day Sunscreen Broad Spectrum Spf 15 Day Facial Spf 15 Against Noticeable Signs Of Aging All Skin Types 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, Octisalate, Octocrylene, And Oxybenzone 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

  • 14783 - Ventura International
    • 14783-119 - Lederm Day Sunscreen Broad Spectrum Spf 15 Day Facial Spf 15 Against Noticeable Signs Of Aging All Skin Types

NDC 14783-119-02

Package Description: 1 BOTTLE in 1 BOX > 50 mL in 1 BOTTLE (14783-119-01)

NDC Product Information

Lederm Day Sunscreen Broad Spectrum Spf 15 Day Facial Spf 15 Against Noticeable Signs Of Aging All Skin Types with NDC 14783-119 is a a human over the counter drug product labeled by Ventura International. The generic name of Lederm Day Sunscreen Broad Spectrum Spf 15 Day Facial Spf 15 Against Noticeable Signs Of Aging All Skin Types is avobenzone, octisalate, octocrylene, and oxybenzone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Ventura International

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.

Lederm Day Sunscreen Broad Spectrum Spf 15 Day Facial Spf 15 Against Noticeable Signs Of Aging All Skin Types 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 30 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 30 mg/mL
  • OXYBENZONE 50 mg/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)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • ALBIZIA JULIBRISSIN BARK (UNII: 0J9G6W44DV)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)
  • C20-22 ALCOHOLS (UNII: O4M0347C6A)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ACACIA (UNII: 5C5403N26O)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)

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
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: 09-15-2017 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.

Lederm Day Sunscreen Broad Spectrum Spf 15 Day Facial Spf 15 Against Noticeable Signs Of Aging All Skin Types Product Label Images

Lederm Day Sunscreen Broad Spectrum Spf 15 Day Facial Spf 15 Against Noticeable Signs Of Aging All Skin Types 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%SunscreenOCTISALATE 5%SunscreenOCTOCRYLENE 3%SunscreenOXYBENZONE 5%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.Use a water resistant sunscreen if swimming or sweating.Reapply at 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, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, GLYCERIN, POTASSIUM CETYL PHOSPHATE, ALBIZIA JULIBRISSIN BARK EXTRACT, DIMETHICONE, GLYCERYL STEARATE, PENTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, HYDROGENATED PALM GLYCERIDES, PHENOXYETHANOL, XANTHAN GUM, C20-22 ALKYL PHOSPHATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, FRAGRANCE, C20-22 ALCOHOLS, CHLORPHENESIN, HYDROLYZED CERATONIA SILIQUA SEED EXTRACT, SODIUM HYDROXIDE, ACACIA SENEGAL GUM, DISODIUM EDTA, OLIVE OIL AMINOPROPANEDIOL ESTERS, RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS, HYDROXYPROPYL CYCLODEXTRIN, PALMITOYL TRIPEPTIDE-38.

* Please review the disclaimer below.