NDC 90069-202 Purpleu Glow Beautifully Bright

Dimethicone, Titanium Dioxide, Zinc Oxide, Niacinamide, Adenosine

NDC Product Code 90069-202

NDC CODE: 90069-202

Proprietary Name: Purpleu Glow Beautifully Bright 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: Dimethicone, Titanium Dioxide, Zinc Oxide, Niacinamide, Adenosine 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used as a moisturizer to treat or prevent dry, rough, scaly, itchy skin and minor skin irritations (e.g., diaper rash, skin burns from radiation therapy). Emollients are substances that soften and moisturize the skin and decrease itching and flaking. Some products (e.g., zinc oxide, white petrolatum) are used mostly to protect the skin against irritation (e.g., from wetness). Dry skin is caused by a loss of water in the upper layer of the skin. Emollients/moisturizers work by forming an oily layer on the top of the skin that traps water in the skin. Petrolatum, lanolin, mineral oil and dimethicone are common emollients. Humectants, including glycerin, lecithin, and propylene glycol, draw water into the outer layer of skin. Many products also have ingredients that soften the horny substance (keratin) that holds the top layer of skin cells together (e.g., urea, alpha hydroxy acids such as lactic/citric/glycolic acid, and allantoin). This helps the dead skin cells fall off, helps the skin keep in more water, and leaves the skin feeling smoother and softer.
  • This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.
  • Niacinamide (nicotinamide) is a form of vitamin B3 (niacin) and is used to prevent and treat niacin deficiency (pellagra). Niacin deficiency can cause diarrhea, confusion (dementia), tongue redness/swelling, and peeling red skin. Niacinamide is often used instead of niacin because it causes fewer side effects (e.g., flushing). Unlike niacin, niacinamide does not help correct blood fat levels and cannot be substituted for niacin if you are being treated for a blood fat problem (e.g., high cholesterol). Niacin deficiency may happen as a result of poor diet, certain medical conditions (e.g., alcohol abuse, malabsorption syndrome, Hartnup disease), or long-term use of certain medications (e.g., isoniazid). It is best to get your vitamins from healthy foods. A multivitamin may be recommended by your doctor instead of niacinamide because poor diet usually causes deficiencies in more than one vitamin. Vitamins help to support the body's ability to make and break down natural substances (metabolism) and are needed for good health.
  • Drug uses not available

NDC Code Structure

  • 90069 - Purple U Co., Ltd

NDC 90069-202-01

Package Description: 35 mL in 1 BOTTLE

NDC Product Information

Purpleu Glow Beautifully Bright with NDC 90069-202 is a a human over the counter drug product labeled by Purple U Co., Ltd. The generic name of Purpleu Glow Beautifully Bright is dimethicone, titanium dioxide, zinc oxide, niacinamide, adenosine. The product's dosage form is cream and is administered via topical form.

Labeler Name: Purple U 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.

Purpleu Glow Beautifully Bright 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.

  • DIMETHICONE 1 g/100mL
  • TITANIUM DIOXIDE 5.89 g/100mL
  • ZINC OXIDE 4.9 g/100mL
  • NIACINAMIDE 2 g/100mL
  • ADENOSINE .04 g/100mL

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.

  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • FRANKINCENSE OIL (UNII: 67ZYA5T02K)
  • VETIVER OIL (UNII: 9M9P32M01L)
  • AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • CARROT SEED OIL (UNII: 595AO13F11)
  • ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
  • ISOTRIDECYL ISONONANOATE (UNII: WEF51750MT)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • OCTINOXATE (UNII: 4Y5P7MUD51)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • STEARIC ACID (UNII: 4ELV7Z65AP)

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: Purple U Co., Ltd
Labeler Code: 90069
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-02-2020 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.

Purpleu Glow Beautifully Bright Product Label Images

Purpleu Glow Beautifully Bright 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 Ingredients

Dimethicone 1.0%Titanium Dioxide 5.89%Zinc Oxide 4.90%Niacinamide 2.0%Adenosine 0.04%

Purpose

Skin ProtectantSunscreenBrighteningWrinkle improvement

Uses

Helps prevent sunburnIf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

  • For external use onlyDo not use on damaged 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 product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Apply liberally 15 minutes before sun exposureReapply at least every 2 hoursUse water resistant sunscreen if swimming or sweatingSun 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 sun, especially from 10a.m.–2 p.m.Wear long-sleeved shirts, pants, hats, and sunglassesChildren under 6 months: ask a doctor

Other Information

Protect this product from excessive heat and direct sun

Inactive Ingredients

Cyclopentasiloxane, Water, Dimethicone, Cyclohexasiloxane, Titanium Dioxide (CI 77891), Ethylhexyl Methoxycinnamate, Zinc Oxide (CI 77947), Dimethicone Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Isotridecyl Isononanoate, Glycerin, Niacinamide, Dicaprylyl Carbonate, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogenated Poly(C6-14 Olefin), Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone, Pentylene Glycol, Polymethyl Methacrylate, Citrus Aurantium Dulcis (Orange) Peel Oil, Boswellia Carterii Oil, Pelargonium Graveolens Flower Oil, Vetiveria Zizanoides Root Oil, Amyris Balsamifera Bark Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Daucus Carota Sativa (Carrot) Seed Oil, Adansonia Digitata Seed Oil, Argania Spinosa Kernel Oil, Hydrolyzed Hyaluronic Acid, Olea Europaea (Olive) Fruit Oil, Hydrolyzed Collagen, Rose Flower Oil, Adansonia Digitata Fruit Extract, PEG-10 Dimethicone, Silica, Disteardimonium Hectorite, Magnesium Sulfate, Synthetic Fluorphlogopite, Stearic Acid, Triethoxycaprylylsilane, Ethylhexylglycerin, Adenosine, Butylene Glycol, Dipalmitoyl Hydroxyproline, Sodium Cocoyl Alaninate, Tocopherol, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum), Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499)

* Please review the disclaimer below.