NDC 71261-009 Jungsaemmool Skin Setting Tone Correcting Base

Octinoxate, Homosalate, Octisalate, Titanium Dioxide, Octocrylene

NDC Product Code 71261-009

NDC CODE: 71261-009

Proprietary Name: Jungsaemmool Skin Setting Tone Correcting Base 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, Homosalate, Octisalate, Titanium Dioxide, Octocrylene 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

  • 71261 - Jungsaemmool Beauty Co., Ltd.
    • 71261-009 - Jungsaemmool Skin Setting Tone Correcting Base

NDC 71261-009-02

Package Description: 1 CONTAINER in 1 CARTON > 40 mL in 1 CONTAINER (71261-009-01)

NDC Product Information

Jungsaemmool Skin Setting Tone Correcting Base with NDC 71261-009 is a a human over the counter drug product labeled by Jungsaemmool Beauty Co., Ltd.. The generic name of Jungsaemmool Skin Setting Tone Correcting Base is octinoxate, homosalate, octisalate, titanium dioxide, octocrylene. The product's dosage form is cream and is administered via topical form.

Labeler Name: Jungsaemmool Beauty 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.

Jungsaemmool Skin Setting Tone Correcting Base 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.

  • OCTINOXATE 65 mg/mL
  • HOMOSALATE 50 mg/mL
  • OCTISALATE 45 mg/mL
  • TITANIUM DIOXIDE 34 mg/mL
  • OCTOCRYLENE 30 mg/mL

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)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DIBUTYL ADIPATE (UNII: F4K100DXP3)
  • DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BEMOTRIZINOL (UNII: PWZ1720CBH)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • MICA (UNII: V8A1AW0880)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • CHROMIC OXIDE (UNII: X5Z09SU859)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SUCROSE STEARATE (UNII: 274KW0O50M)
  • SQUALANE (UNII: GW89575KF9)
  • JOJOBA OIL (UNII: 724GKU717M)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
  • CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
  • ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • PREZATIDE COPPER (UNII: 6BJQ43T1I9)

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: Jungsaemmool Beauty Co., Ltd.
Labeler Code: 71261
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: 07-14-2020 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 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.

Jungsaemmool Skin Setting Tone Correcting Base Product Label Images

Jungsaemmool Skin Setting Tone Correcting Base 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 6.5%


Homosalate 5.0%


Octisalate 4.5%


Titanium Dioxide 3.4%


Octocrylene 3.0%

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), BUTYLENE GLYCOL, DIBUTYL ADIPATE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, GLYCERYL STEARATE, ALCOHOL DENAT., GLYCERIN, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, TITANIUM DIOXIDE (CI 77891), PEG-100 STEARATE, 1,2-HEXANEDIOL, METHYL METHACRYLATE CROSSPOLYMER, CETEARYL ALCOHOL, POLYGLYCERYL-2 CAPRATE, PANTHENOL, CAPRYLYL METHICONE, POLYSORBATE 60, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, MICA, OCTYLDODECANOL, CHROMIUM OXIDE GREENS (CI 77288), FRAGRANCE (PARFUM), CAPRYLYL GLYCOL, SUCROSE STEARATE, SQUALANE, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, IRON OXIDES (CI 77492), STEARIC ACID, ALUMINA, GLYCERYL CAPRYLATE, CENTELLA ASIATICA EXTRACT, POLYACRYLATE-13, XANTHAN GUM, ETHYLHEXYLGLYCERIN, POLYACRYLATE CROSSPOLYMER-6, ECHIUM PLANTAGINEUM SEED OIL, ALUMINUM HYDROXIDE, POLYISOBUTENE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES, POLYSORBATE 20, SORBITAN ISOSTEARATE, CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT, t-BUTYL ALCOHOL, ETHYLHEXYL PALMITATE, SODIUM PCA, TOCOPHEROL, TRIHYDROXYSTEARIN, SODIUM HYALURONATE, COPPER TRIPEPTIDE-1

Other Safety Information

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

* Please review the disclaimer below.