NDC 50066-119 Scar Cream Spf 30

Avobenzone, Octocrylene, Oxybenzone

NDC Product Code 50066-119

NDC Code: 50066-119

Proprietary Name: Scar Cream 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, Octocrylene, 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

  • 50066 - Genomma Lab
    • 50066-119 - Scar Cream Spf 30

NDC 50066-119-01

Package Description: 1 TUBE in 1 CARTON > 19.8 g in 1 TUBE

NDC Product Information

Scar Cream Spf 30 with NDC 50066-119 is a a human over the counter drug product labeled by Genomma Lab. The generic name of Scar Cream Spf 30 is avobenzone, octocrylene, oxybenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Genomma Lab

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Scar Cream 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 3 g/100g
  • OXYBENZONE 6 g/100g
  • OCTOCRYLENE 10 g/100g

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.

  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GARDEN CRESS SPROUT (UNII: PWQ18YNR62)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • JOJOBA OIL (UNII: 724GKU717M)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • MATRICARIA RECUTITA LEAF (UNII: 6I9LN466F0)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • DIMETHICONE 200 (UNII: RGS4T2AS00)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • WATER (UNII: 059QF0KO0R)
  • ONION (UNII: 492225Q21H)
  • SORBITOL (UNII: 506T60A25R)
  • POLYESTER-7 (UNII: 0841698D2F)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • ALLANTOIN (UNII: 344S277G0Z)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)

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: Genomma Lab
Labeler Code: 50066
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: 02-22-2019 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: 12-31-2020 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.

Scar Cream Spf 30 Product Label Images

Scar Cream 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

Active Ingredients

Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

For external use only.
Skin Cancer/Skin Aging Alert: spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer and early skin aging.
Do not use on damaged or broken skin.
When using this product keep out of eyes. Rinse eyes with water to remove.
Stop use and ask a doctor if rash occurs.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply generously and evenly 15 minutes before sun exposure. Reapply:at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingChildren under 6 months: ask a doctor.

Inactive Ingredients

Water, Allium Cepa (Onion) Bulb Extract, Sorbitan Isostearate, Sorbitol, Polyester-7, VP/Eicosene Copolymer, Glyceryl Caprylate, decolorized Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Lepidium Sativum (Cress) Sprout Extract, Allantoin, Tocopherol, Stearic Acid, Polysorbate 80, Carbomer, Dimethicone, Disodium EDTA, Lecithin, Glycerin, Neopentyl Glycol Diheptanoate, Polyglyceryl-3 Distearate, Benzyl Alcohol, Triethanolamine, Phenoxyethanol

* Please review the disclaimer below.

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