NDC 70905-0019 Dr.althea Double Serum Balm Foundation 23

Octinoxate, Octisalate, Titanium Dioxide, Homosalate

NDC Product Code 70905-0019

NDC CODE: 70905-0019

Proprietary Name: Dr.althea Double Serum Balm Foundation 23 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: Octinoxate, Octisalate, Titanium Dioxide, Homosalate 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

  • 70905 - Dr.althea Co.,ltd
    • 70905-0019 - Dr.althea Double Serum Balm Foundation 23

NDC 70905-0019-2

Package Description: 2 CONTAINER in 1 CARTON > 12 g in 1 CONTAINER (70905-0019-1)

NDC Product Information

Dr.althea Double Serum Balm Foundation 23 with NDC 70905-0019 is a a human over the counter drug product labeled by Dr.althea Co.,ltd. The generic name of Dr.althea Double Serum Balm Foundation 23 is octinoxate, octisalate, titanium dioxide, homosalate. 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.althea Double Serum Balm Foundation 23 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)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
  • CERESIN (UNII: Q1LS2UJO3A)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • GLYCERETH-26 (UNII: NNE56F2N14)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SQUALANE (UNII: GW89575KF9)
  • METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • HEXADECENE (MIXED ISOMERS) (UNII: 38H8547VP0)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

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: Dr.althea Co.,ltd
Labeler Code: 70905
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: 12-08-2021 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: 12-31-2022 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.althea Double Serum Balm Foundation 23 Product Label Images

Dr.althea Double Serum Balm Foundation 23 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

Octinoxate 7.00%Octisalate 4.80%Titanium Dioxide 4.56%Homosalate 2.50%

Otc - Purpose

Sunscreen

Indications & Usage

Helps prevent sunburn

Dosage & Administration

Apply liberally 15 minutes before sun exposure. Reapply at least every two hoursSun 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglassesAsk a doctor to use for children under 6 months

Warnings

For external use onlyDo not use on damaged or broken skinWhen 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 (Aqua), Dipropylene Glycol, Phenyl Trimethicone, Cyclopentasiloxane, C30-45 Alkyldimethylsilyl Polypropylsilsesquioxane, Niacinamide, Diisostearyl Malate, VP/Hexadecene Copolymer, Ceresin, Cyclohexasiloxane, Glycereth-26, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Sodium Chloride, Adansonia Digitata Seed Extract, Camellia Japonica Flower Extract, Hyaluronic Acid, Ceramide NP, Hexapeptide-9, Acetyl Hexapeptide-8, Tripeptide-1, Tripeptide-32, Chitosan, Hydrogenated Lecithin, Dimethicone, Methyl Methacrylate Crosspolymer, Squalane, Aluminum Hydroxide, Acrylates/Ethylhexyl Acrylate/Dimethicone Methacrylate Copolymer, Glyceryl Caprylate, Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Hexadecene, Triethoxycaprylylsilane, Disodium Stearoyl Glutamate, Adenosine, Glycerin, Caprylic/Capric Triglyceride, Tripropylene Glycol, Sodium Citrate, Butylene Glycol, Propylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Tocopherol, Tocopheryl Acetate, Disodium EDTA, BHT, Phenoxyethanol, Fragrance (Parfum), Ultramarines, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

Other Safety Information

Protect the product in the container from excessive heat and direct sun

* Please review the disclaimer below.