NDC 49404-145 Dr.jart Dis-a-pore Beauty Balm 01

Titanium Dioxide, Octinoxate, Octisalate

NDC Product Code 49404-145

NDC CODE: 49404-145

Proprietary Name: Dr.jart Dis-a-pore Beauty Balm 01 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: Titanium Dioxide, Octinoxate, Octisalate 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

  • 49404 - Have & Be Co., Ltd.
    • 49404-145 - Dr.jart Dis-a-pore Beauty Balm 01

NDC 49404-145-02

Package Description: 1 CONTAINER in 1 CARTON > 40 mL in 1 CONTAINER (49404-145-01)

NDC Product Information

Dr.jart Dis-a-pore Beauty Balm 01 with NDC 49404-145 is a a human over the counter drug product labeled by Have & Be Co., Ltd.. The generic name of Dr.jart Dis-a-pore Beauty Balm 01 is titanium dioxide, octinoxate, octisalate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Have & Be Co., Ltd.

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.

Dr.jart Dis-a-pore Beauty Balm 01 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.

  • TITANIUM DIOXIDE 6.388 mg/40mL
  • OCTINOXATE 1.996 mg/40mL
  • OCTISALATE 1.2 mg/40mL

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)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
  • ISODODECANE (UNII: A8289P68Y2)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)

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: Have & Be Co., Ltd.
Labeler Code: 49404
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: 11-07-2019 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.

Dr.jart Dis-a-pore Beauty Balm 01 Product Label Images

Dr.jart Dis-a-pore Beauty Balm 01 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

Otc - Active Ingredient

Titanium Dioxide 15.97%Octinoxate 4.99%Octisalate 3.00%

Otc - Purpose

Sunscreen

Indications & Usage

Helps prevent sunburnIf used as directed with other sun protection meausres (see











Directions), decreases the risk of skin cancer and early skin aging casued by the sun

Dosage & Administration

  • Apply liberally 15 minutes before sun exposure.Use a water resistant sunscreen if swimming or sweatingReapply at least every 2 hours.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 value of 15 or higher and other sun protection measures including: – Limit time in the sun, especially from 10 am - 2 pm– Wear long-sleeved shirts, pants, hats and
  • Sunglasses
  • Children under 6 months: Ask a doctor

Warnings

For external use only.











Do not use on damaged or broken skin.











When using this product, keep out of eyes. Rinse with water to remove.











Stop using and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

Inactive Ingredient

WATER, CYCLOPENTASILOXANE, DIMETHICONE/VINYL DIMETHICONECROSSPOLYMER, ISODODECANE, LAURYL PEG-10TRIS(TRIMETHYLSILOXY)SILYLETHYLDIMETHICONE, DIMETHICONE, NIACINAMIDE, METHYLPROPANEDIOL, BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE, IRON OXIDES(CI 77492), SYNTHETIC FLUORPHLOGOPITE, DISTEARDIMONIUM HECTORITE, GLYCERIN, MAGNESIUM SULFATE, ISOPROPYL PALMITATE, HDI/TRIMETHYLOL HEXYLLACTONECROSSPOLYMER, TRIETHOXYCAPRYLYLSILANE, DIPENTAERYTHRITYLHEXAHYDROXYSTEARATE/HEXASTEARATE/HEXAROSINATE, POLYGLYCERYL-4 ISOSTEARATE, ALUMINUM HYDROXIDE, IRON OXIDES(CI 77491), CAPRYLYL GLYCOL, IRON OXIDES(CI 77499), GLYCERYL CAPRYLATE, TRIHYDROXYSTEARIN, ETHYLHEXYLGLYCERIN, PINUS SYLVESTRIS LEAF OIL, CITRUS AURANTIUM BERGAMIA (BERGAMOT)FRUIT OIL, SILICA, ADENOSINE, BHT, TOCOPHEROL, BUTYLENE GLYCOL, ALCOHOL, 1,2-HEXANEDIOL, LECITHIN, PISTACIA LENTISCUS (MASTIC) GUM

Other Safety Information

Protect the product in this container from excessive heat and direct sunlight.

* Please review the disclaimer below.