NDC 50066-121 Advanced Anti-wrinkle Therapy Cicatricure

Avobenxone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 2.7%, Oxybenzone 4%

NDC Product Code 50066-121

NDC Code: 50066-121

Proprietary Name: Advanced Anti-wrinkle Therapy Cicatricure Additional informationCallout TooltipWhat 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: Avobenxone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 2.7%, Oxybenzone 4% Additional informationCallout TooltipWhat 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.


Code Structure
  • 50066 - Genomma Lab
    • 50066-121 - Advanced Anti-wrinkle Therapy

NDC 50066-121-01

Package Description: 1 TUBE in 1 CARTON > 42 g in 1 TUBE

NDC Product Information

Advanced Anti-wrinkle Therapy Cicatricure with NDC 50066-121 is a a human over the counter drug product labeled by Genomma Lab. The generic name of Advanced Anti-wrinkle Therapy Cicatricure is avobenxone 3%, octinoxate 7.5%, octisalate 5%, octocrylene 2.7%, oxybenzone 4%. 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 Additional informationCallout TooltipWhat 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.


Advanced Anti-wrinkle Therapy Cicatricure Active Ingredient(s)

Additional informationCallout TooltipWhat 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
  • OCTINOXATE 7.5 g/100g
  • OCTISALATE 5 g/100g
  • OCTOCRYLENE 2.7 g/100g
  • OXYBENZONE 4 g/100g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
  • PPG-2 ISOCETETH-20 ACETATE (UNII: BI6C7YO419)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • BAKUCHIOL (UNII: OT12HJU3AR)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • RETINOL (UNII: G2SH0XKK91)
  • HYDROXYPINACOLONE RETINOATE (UNII: NJ3V2F02E1)
  • MYRISTOYL PENTAPEPTIDE-4 (UNII: PMA59A699X)
  • PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SODIUM ASCORBATE (UNII: S033EH8359)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-21-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Advanced Anti-wrinkle Therapy Cicatricure Product Label Images

Advanced Anti-wrinkle Therapy Cicatricure 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 Purpose

Avobenzone 3%........................................Sunscreen

Octinoxate 7.5%.......................................Sunscreen

Octisalate 5%...........................................Sunscreen

Octocrylene 2.7%.....................................Sunscreen

Oxybenzone 4%........................................Sunscreen

Otc - Purpose

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 onlyDo not use on damaged or broken skin
When using this product keep out of eyes.Rinse with water to remove.
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 immediately

Directions

For sunscreen use: • apply generously and evenly 15

minutes before sun exposure. Reapply at least every

2 hours • use a water resistant sunscreen if swimming

or sweating.
Sun 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 factor of 15 or

higher and other skin protection measures including:

• limit time in the sun, especially from 10am to 2pm

• wear long-sleeved shirts, pants, hats and sunglasses

• children under 6 months of age: ask a doctor

Inactive Ingredients

Water

Glycerin

Dimethicone

Ethylhexyl Methoxycrylene

Neopentyl Glycol Diheptanoate

Glyceryl Stearate

Butylene Glycol

Isostearyl Neopentanoate

PPG-2 Isoceteth-20 Acetate

Polymethyl Methacrylate

Acrylamide/Sodium Acryloyldimethyltaurate Copolymer

Bakuchiol

Retinyl Palmitate

Tocopheryl Acetate

Bisabolol

Cetearyl Alcohol

Sorbitan Oleate

Retinol

Hydroxypinacolone Retinoate

Myristoyl Nanapeptide-3

Palmitoyl Oligopeptide

Palmitoyl Tetrapeptide-7

Tocopherol

Sodium Ascorbate

Sodium Hyaluronate

Caprylic/Capric Triglyceride

Dimethicone Crosspolymer

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Behenyl Alcohol

Sodium Lactate

Ethylhexylglycerin

Isohexadecane

Polysorbate 80

Polysorbate 20

Dimethyl Isosorbide

Xanthan Gum

Carbomer

Disodium EDTA

Sodium Hydroxide

Pentylene Glycol

Chlorphenesin

Phenoxyethanol

Caprylyl Glycol

Citric Acid

Potassium Sorbate

Fragrance

* Please review the disclaimer below.

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