NDC 90069-201 Purpleu Baobab And Rose Deep Hydration Cream Therapy

Dimethicone

  1. Labeler Index
  2. Purple U Co., Ltd
  3. NDC: 90069-201 Purpleu Baobab And Rose Deep Hydration Cream Therapy

NDC Product Code 90069-201

NDC CODE: 90069-201

Proprietary Name: Purpleu Baobab And Rose Deep Hydration Cream Therapy 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 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.

NDC Code Structure

  • 90069 - Purple U Co., Ltd
    • 90069-201 - Purpleu Baobab And Rose Deep Hydration Cream Therapy

NDC 90069-201-01

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Purpleu Baobab And Rose Deep Hydration Cream Therapy with NDC 90069-201 is a a human over the counter drug product labeled by Purple U Co., Ltd. The generic name of Purpleu Baobab And Rose Deep Hydration Cream Therapy is dimethicone. 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 Baobab And Rose Deep Hydration Cream Therapy 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 .3 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.
  • CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
  • DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)
  • PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)
  • BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • FARNESOL (UNII: EB41QIU6JL)
  • AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
  • ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • HOLY BASIL LEAF (UNII: SCJ765569P)
  • GINKGO BILOBA SEED (UNII: 8CQ734K3W7)
  • DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)
  • PEG/PPG-17/6 COPOLYMER (UNII: P5QZM4T259)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAMELLIA OIL (UNII: T1PE06G0VE)
  • TURMERIC (UNII: 856YO1Z64F)
  • ROSEMARY (UNII: IJ67X351P9)
  • WHITE MULBERRY (UNII: MN25R0HH5A)
  • HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • DIPENTAERYTHRITYL HEXASTEARATE (UNII: WTF09990PK)
  • ADANSONIA DIGITATA FRUIT (UNII: 51N9TR1W6P)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ECLIPTA PROSTRATA LEAF (UNII: H86R96580E)
  • .ALPHA.-AMYLCINNAMYL ALCOHOL (UNII: DKB52S61GU)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • CORALLINA OFFICINALIS (UNII: 4004498D06)
  • MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)
  • FIG (UNII: TGD87RII2U)
  • POMEGRANATE (UNII: 56687D1Z4D)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • GERANIOL (UNII: L837108USY)
  • BENZYL BENZOATE (UNII: N863NB338G)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)

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
FDA Application Number: part347 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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 Baobab And Rose Deep Hydration Cream Therapy Product Label Images

Purpleu Baobab And Rose Deep Hydration Cream Therapy 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 0.3%

Purpose

Skin Protectant

Uses

Helps protectant the skin from outside environment

Warnings

For external use onlyDo not use on damaged or broken skinWhen using this product keep out of eyesRinse with water to remove

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If productis swallowed, get medical help or contact a Poison Control Center right away.

Directions

Use at any desired time. Scoop the desired amount of the luxurious hydration cream with the spatula that is provided with the cream. Then apply in an upward and outward motion to the face and it also can be applied on the neck and body.

Inactive Ingredients

Water, Adansonia Digitata Fruit Extract, Glycerin, Butylene Glycol, Octyldodecanol, Cyclopentasiloxane, Glyceryl Stearate, Pentylene Glycol, Phenyl Trimethicone, Cetearyl Alcohol, Cetyl Alcohol, Cyclohexasiloxane, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Rosa Damascena Flower Water, Copernicia Cerifera (Carnauba) Wax, Eclipta Prostrata Extract, Melia Azadirachta Leaf Extract, Melia Azadirachta Flower Extract, Adansonia Digitata Seed Oil, Camellia Japonica Seed Oil, Camellia Oleifera Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Curcuma Longa(Turmeric) Root Extract, Ocimum Sanctum Leaf Extract, Pelargonium Graveolens Flower Oil, Corallina Officinalis Extract, Moringa Oleifera Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Ficus Carica (Fig) Fruit Extract, Ginkgo Biloba Nut Extract, Morus Alba Fruit Extract, Punica Granatum Fruit Extract, Hamamelis Virginiana (Witch Hazel) Extract, Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/ Hexarosinate, PEG-20 Methyl Glucose Sesquistearate, PEG/PPG-17/6 Copolymer, PEG-100 Stearate, Bis-Diglyceryl Polyacyladipate-2, Panthenol, Hydroxyacetophenone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tromethamine, Sodium Polyacrylate Starch, Dimethicone/ Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Disodium EDTA, Phenoxyethanol, Fragrance(Parfum), Citronellol, Hexyl Cinnamal, Geraniol, Butylphenyl Methylpropional, Farnesol, Benzyl Benzoate, Amylcinnamyl Alcohol, Linalool

* Please review the disclaimer below.