NDC 67225-2025 Aekyungluna Long Lasting Tip Concealer Fixing-fit 02 Natural Beige

Titanium Dioxide

NDC Product Code 67225-2025

NDC CODE: 67225-2025

Proprietary Name: Aekyungluna Long Lasting Tip Concealer Fixing-fit 02 Natural Beige 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 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

  • 67225 - Aekyung Industrial Co., Ltd.
    • 67225-2025 - Aekyungluna Long Lasting Tip Concealer Fixing-fit 02 Natural Beige

NDC 67225-2025-2

Package Description: 1 BOTTLE, WITH APPLICATOR in 1 BOX > 7.5 g in 1 BOTTLE, WITH APPLICATOR (67225-2025-1)

NDC Product Information

Aekyungluna Long Lasting Tip Concealer Fixing-fit 02 Natural Beige with NDC 67225-2025 is a a human over the counter drug product labeled by Aekyung Industrial Co., Ltd.. The generic name of Aekyungluna Long Lasting Tip Concealer Fixing-fit 02 Natural Beige is titanium dioxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Aekyung Industrial 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.

Aekyungluna Long Lasting Tip Concealer Fixing-fit 02 Natural Beige 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 1.7 g/7.5g

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.

  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • PINUS KORAIENSIS SEED OIL (UNII: 08F703RHY3)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ADENOSINE (UNII: K72T3FS567)
  • PINUS SYLVESTRIS CONE (UNII: 856B44M480)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • P-ANISIC ACID (UNII: 4SB6Y7DMM3)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • TALC (UNII: 7SEV7J4R1U)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • THYMUS VULGARIS LEAF (UNII: GRX3499643)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
  • DIMETHICONE 100 (UNII: RO266O364U)
  • ROSEMARY (UNII: IJ67X351P9)

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: Aekyung Industrial Co., Ltd.
Labeler Code: 67225
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: 04-13-2021 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.

Aekyungluna Long Lasting Tip Concealer Fixing-fit 02 Natural Beige Product Label Images

Aekyungluna Long Lasting Tip Concealer Fixing-fit 02 Natural Beige 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 Ingredient

Titanium dioxide 22.68 %

Uses

Helps prevent sunburn

Warnings

For external use only.

Do Not Use

On damaged skin or broken skin

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

If rash occurs

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ Apply an appropriate amount to the area that

needs to be covered, then tap it with your fingers to absorb

cleanly. ■ Apply liberally 15 minutes before sun exposure. 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 sunprotection measuring including:

• limit time in the sun, especially from 10 a.m. - 2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses

■ Children under 6 months of age: Ask a doctor

■ Reapply at least every 2 hours.

■ Use a water-resistant sunscreen if swimming or sweating.

Other Information

■ Store at room temperature

Inactive Ingredients

Water, Cyclopentasiloxane, Phenyl

Trimethicone, Silica, Cetyl PEG/PPG-10/1 Dimethicone,

Butylene Glycol, Talc, Trimethylsiloxysilicate, Niacinamide, Vinyl

Dimethicone/Methicone Silsesquioxane Crosspolymer, Sodium Chloride,

PEG-10 Dimethicone, Polymethylsilsesquioxane, Triethoxycaprylylsilane,

Disteardimonium Hectorite, Aluminum Hydroxide, Acrylates/Stearyl

Acrylate/Dimethicone Methacrylate Copolymer, p-Anisic Acid, Glyceryl

Caprylate, Palmitic Acid, Dimethicone, Stearic Acid, Adenosine,

1,2-Hexanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract,

Thymus Vulgaris (Thyme) Leaf Extract, Chamaecyparis Obtusa Leaf

Extract, Pinus Sylvestris Cone Extract, Pinus Koraiensis Seed Extract,

Fragrance, May contain: Iron Oxides (CI 77492, CI 77491, CI 77499)

* Please review the disclaimer below.