NDC 20146-4007 La Bodies Eclipse Sunscreen Spf 30

Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone

NDC Product Code 20146-4007

NDC Code: 20146-4007

Proprietary Name: La Bodies Eclipse Sunscreen Spf 30 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, 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

NDC 20146-4007-1

Package Description: 28 g in 1 TUBE

NDC 20146-4007-2

Package Description: 85 g in 1 TUBE

NDC Product Information

La Bodies Eclipse Sunscreen Spf 30 with NDC 20146-4007 is a a human over the counter drug product labeled by Samson Pharmaceutical. The generic name of La Bodies Eclipse Sunscreen Spf 30 is avobenzone, homosalate, octisalate, octocrylene, and oxybenzone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Samson Pharmaceutical

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.

La Bodies Eclipse Sunscreen Spf 30 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 20 mg/g
  • HOMOSALATE 130 mg/g
  • OCTISALATE 50 mg/g
  • OCTOCRYLENE 20 mg/g
  • OXYBENZONE 40 mg/g

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)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)

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: Samson Pharmaceutical
Labeler Code: 20146
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: 01-01-2015 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: 12-31-2019 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.

La Bodies Eclipse Sunscreen Spf 30 Product Label Images

La Bodies Eclipse Sunscreen Spf 30 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

Manufactured by:Samson Pharmaceutical Inc.Commerce, CA 90040

Active Ingredients

Avobenzone 2%, Homosalate 13%, Octisalate 5%, Octocrylene 2% and Oxybenzone 4%

Purpose

Sunscreen

Use

Helps prevent sunburn

Warnings

For external use only

When Using This Product

  • Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop Use And Ask A Doctor If

  • Irritation or rash develops

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 and evenly to all areas 15 minutes before sun exposurereapply at frequent intervals and after swimming or towel dryingask a doctor before use on children under six months of age

Other Information

  • May stain some materials

Inactive Ingredients

Water (Aqua), Stearyl Alcohol, Cetyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Aloe Barbadensis Leaf Juice, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid,Menthone Glycerin Acetal, Dimethicone, Ethylhexyl Palmitate, Mineral Oil, PEG-8, Citric Acid, PVP, Carbomer, Triethanolamine, Tetrasodium EDTA, Phenoxyethanol,Methylparaben, Propylparaben, Ethylparaben, Butylparaben, Isobutylparaben, Fragrance (Parfum), Lilial, Gamma Methyl Ionone, Lyral, Coumarin, Linalool

* Please review the disclaimer below.