NDC 72296-020 Tula Breakout Star Oil-free Acne Moisturizer

Tula Breakout Star Oil-free Acne Moisturizer

NDC Product Information

Tula Breakout Star Oil-free Acne Moisturizer with NDC 72296-020 is a a human over the counter drug product labeled by Tula Life Llc. The generic name of Tula Breakout Star Oil-free Acne Moisturizer is tula breakout star oil-free acne moisturizer. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Tula Life Llc

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Tula Breakout Star Oil-free Acne Moisturizer 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.

  • SALICYLIC ACID 2 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.

  • WATER (UNII: 059QF0KO0R)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
  • LACTOCOCCUS LACTIS (UNII: F1A0PSN10V)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AZELAIC ACID (UNII: F2VW3D43YT)
  • BISABOLOL OXIDE A (UNII: 16AE65F94Y)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CITRULLUS LANATUS WHOLE (UNII: 3J5I6254YO)
  • CITRUS AURANTIUM FLOWER (UNII: O730ZX2Z83)
  • EPILOBIUM ANGUSTIFOLIUM WHOLE (UNII: C278QS9YBT)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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.
  • 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: Tula Life Llc
Labeler Code: 72296
FDA Application Number: part333D 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: 11-25-2019 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.

Tula Breakout Star Oil-free Acne Moisturizer Product Label Images

Tula Breakout Star Oil-free Acne Moisturizer 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

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

• treats acne• Helps prevent the development or new acne blemishes

Warnings

For external use only


Using other topical medications at the same time or


immediately following use of this product may increase


dryness or irritation of the skin. If this occurs, only one


medication should be used unless directed by a doctor.


When using this product


• avoid contact with the eyes


• if contact occurs, rinse thoroughly with water

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

• clean the skin thoroughly before applying this product


• cover the entire affected area with a thin layer one to three


times daily


• because excessive drying of the skin may occur, start with


one application daily, then gradually increase to two or three


times daily if needed or as directed by a doctor


• if bothersome dryness or peeling occurs, reduce application


to once a day or every other day

Inactive Ingredients

Aqua/Water/Eau, Propanediol, Dimethicone, Glycerin, Dimethyl Isosorbide, Lactococcus Ferment Lysate, Polysorbate 20, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Niacinamide, Aloe Barbadensis Leaf Juice, Azelaic Acid, Bisabolol, Cetearyl Olivate, Cirusllus Lanatus (Watermelon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Epilobium


Angustifolium Flower/Leaf/Stem Extract, Lactic Acid, Lens Esculenta (Lentil) Fruit Extract, Ocimum Sanctum Leaf Extract, Ocimum Sanctum Leaf Extract, Ozonized Oryza Sativa (Rice) Callus Culture Extract, Phenoxyethanol, Polyacrylate Crosspolymer-6, Saccharide Isomerate, Sodium Chloride, Sodium Lactate, Sodium PCA, Sorbitan Isostearate, Sorbitan Olivate, Trisodium Ethylenediamine Disuccinate, Ethylhexylglycerin, Xanthan Gum

* Please review the disclaimer below.