NDC 14222-2130 Unblemish Shine Free

Titanium Dioxide, Zinc Oxide

NDC Product Code 14222-2130

NDC Code: 14222-2130

Proprietary Name: Unblemish Shine Free Additional informationCallout TooltipWhat 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, Zinc Oxide Additional informationCallout TooltipWhat 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.


Code Structure
  • 14222 - Rodan & Fields
    • 14222-2130 - Unblemish Shine Free

NDC 14222-2130-1

Package Description: 1 TUBE in 1 CARTON > 30 mL in 1 TUBE

NDC Product Information

Unblemish Shine Free with NDC 14222-2130 is a a human over the counter drug product labeled by Rodan & Fields. The generic name of Unblemish Shine Free is titanium dioxide, zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Rodan & Fields

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Unblemish Shine Free Active Ingredient(s)

Additional informationCallout TooltipWhat 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 .03 g/mL
  • ZINC OXIDE .14 g/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • BOERHAVIA DIFFUSA ROOT (UNII: KR0SR09KYL)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • CHOLESTEROL (UNII: 97C5T2UQ7J)
  • DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • DIMETHICONOL (600000 CST) (UNII: RKI3S914RT)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • SQUALANE (UNII: GW89575KF9)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • GERANIOL (UNII: L837108USY)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Rodan & Fields
Labeler Code: 14222
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-13-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Unblemish Shine Free Product Label Images

Unblemish Shine Free 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

Titanium Dioxide 3%
Zinc Oxide 14%

Purpose

Sunscreen
Sunscreen

Uses

  • Helps prevent sunburn.
  • Lf 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 only

Otc - Do Not Use

  • Do not useOn damaged or broken skin.

Otc - When Using

  • When using this productKeep out of eyes. Rinse with water to remove.

Otc - Stop Use

  • Stop use and ask a doctorIf rash occurs.

Otc - Keep Out Of Reach Of Children

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

Directions

  • Apply liberally 15 minutes before sun exposure.
  • Reapply every 2 hours.
  • Use a water-resistant sunscreen if swimming or sweating.
  • 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 of 15or higher and other sun protection measures including:Limit time in the sun, especially from 10 a.m.-2 p.m.
  • Wear long-sleeve shirts, pants, hats and sunglasses.
  • Children under 6 months: Ask a doctor.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water,Cyclopentasiloxane,Dimethicone, Butyloctyl Salicylate, PEG-10 Dimethicone, Pentylene Glycol, Cetearyl Alcohol, Styrene/Acrylates Copolymer, Butylene Glycol, Hexyl Laurate, Polysilicone-11, Tocopheryl Acetate, Boerhavia Diffusa Root Extract, Sodium PCA, Tetrahexyldecyl Ascorbate, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Cholesterol, Glycerin, Sorbitan Stearate, Oleanolic Acid, Polyglyceryl-4 lsostearate, Sorbitan lsostearate, Squalane, Stearic Acid, Fragrance, Alumina, Carbomer, Ceteth-10 Phosphate, Dicetyl Phosphate, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxypropyl Methylcellulose Stearoxy Ether, Ammonium Polyacryloyldimethyl Taurate, Polysorbate 10, Polysorbate 60, Polysorbate 80, lsohexadecane, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Sodium Metabisulfite, Caprylyl Glycol, 1,2-Hexanediol, Chlorphenesin, Phenoxyethanol, Limonene, Linalool, Citronellol, Geraniol.

Questions

1-888-995-5656

* Please review the disclaimer below.

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