NDC 49404-141 Dr.jart Premium Beauty Balm 03 Deep

Titanium Dioxide, Zinc Oxide, Octinoxate, Octisalate

NDC Product Code 49404-141

NDC CODE: 49404-141

Proprietary Name: Dr.jart Premium Beauty Balm 03 Deep 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, Zinc Oxide, 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.
    • 49404-141 - Dr.jart Premium Beauty Balm 03 Deep

NDC 49404-141-02

Package Description: 1 CONTAINER in 1 CARTON > 40 mL in 1 CONTAINER (49404-141-01)

NDC Product Information

Dr.jart Premium Beauty Balm 03 Deep with NDC 49404-141 is a a human over the counter drug product labeled by Have & Be Co., Ltd.. The generic name of Dr.jart Premium Beauty Balm 03 Deep is titanium dioxide, zinc oxide, octinoxate, octisalate. The product's dosage form is cream and is administered via topical form.

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 Premium Beauty Balm 03 Deep 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.


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)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TALC (UNII: 7SEV7J4R1U)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • ADENOSINE (UNII: K72T3FS567)
  • PINE NEEDLE OIL (PINUS SYLVESTRIS) (UNII: 5EXL5H740Y)
  • LIME OIL (UNII: UZH29XGA8G)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • LEMON OIL (UNII: I9GRO824LL)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • ALLANTOIN (UNII: 344S277G0Z)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • PLATINUM (UNII: 49DFR088MY)
  • PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)

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: 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: 09-11-2018 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: 12-31-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dr.jart Premium Beauty Balm 03 Deep Product Label Images

Dr.jart Premium Beauty Balm 03 Deep 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 5.8%Zinc Oxide 5.00%Octinoxate 6.79Octisalate 4.50%

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


CYCLOHEXASILOXANE


GLYCERIN


TALC


PEG-10 DIMETHICONE


IRON OXIDES(CI 77492)


C12-15 ALKYL BENZOATE


NIACINAMIDE


DIPHENYLSILOXY PHENYL TRIMETHICONE


DIPROPYLENE GLYCOL


HEXYL LAURATE


DISTEARDIMONIUM HECTORITE


MAGNESIUM SULFATE


DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER


DIMETHICONE


IRON OXIDES(CI 77491)


TRIETHOXYCAPRYLYLSILANE


PHENOXYETHANOL


IRON OXIDES(CI 77499)


METHICONE


POLYGLYCERYL-6 POLYRICINOLEATE


ETHYLHEXYLGLYCERIN


TRIHYDROXYSTEARIN


CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL


ADENOSINE


PINUS SYLVESTRIS LEAF OIL


CITRUS AURANTIFOLIA (LIME) OIL


BHT


EUCALYPTUS GLOBULUS LEAF OIL


CITRUS LIMON (LEMON) PEEL OIL


CITRUS AURANTIUM BERGAMIA (BERGAMOT) FRUIT OIL


ALLANTOIN


GLYCERYL POLYMETHACRYLATE


PROPYLENE GLYCOL


1,2-HEXANEDIOL


PLATINUM POWDER


PALMITOYL TRIPEPTIDE-1


POLYSORBATE 80

Other Safety Information

Protect the product in this container from excessive heat and direct sunlightYou may report a serious adverse event from use of this product to: Report Reaction, LLC PO Box 22 Plainsboro, NJ 08536-0222

* Please review the disclaimer below.