NDC 51417-0003 Ren Clean Favourites

Zinc Oxide

NDC Product Code 51417-0003

NDC 51417-0003-1

Package Description: 1 KIT in 1 KIT * 1 TUBE in 1 BOX (51417-0002-1) > 10 mL in 1 TUBE

NDC Product Information

Ren Clean Favourites with NDC 51417-0003 is a a human over the counter drug product labeled by Ren Ltd. The generic name of Ren Clean Favourites is zinc oxide. The product's dosage form is kit and is administered via form.

Labeler Name: Ren Ltd

Dosage Form: Kit - A packaged collection of related material.

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.

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)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CAPRYLYL CAPRYLATE/CAPRATE (UNII: 22MCG4RSMR)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • STARCH, RICE (UNII: 4DGK8B7I3S)
  • KARUM SEED OIL (UNII: 62160PU6FJ)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERYL OLEATE (UNII: 4PC054V79P)
  • CRANBERRY SEED OIL (UNII: 73KDS3BW5E)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • MANDARIN OIL (UNII: NJO720F72R)
  • CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Ren Ltd
Labeler Code: 51417
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: 09-01-2019 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: 12-31-2020 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.

Ren Clean Favourites 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

Zinc Oxide 22%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.If 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

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

Directions

  • Apply liberally 15 minutes before sun exposure Reapply at least every 2 hoursUse a 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 the sun, especially from 10 a.m. - 2p.m.Wear long-sleeved shirts, pants, hats and sunglassesChildren under 6 months of age: Ask a doctor

Other Information

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

Inactive Ingredients

Aqua (Water), Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Glycerin, Caprylyl Caprylate/Caprate, Propanediol, Arachidyl Alcohol, Cetearyl Alcohol, Coco-Glucoside, Oryza Sativa Starch, Pongamia Glabra Seed Oil, Microcrystalline Cellulose, Behenyl Alcohol, Phenoxyethanol, Arachidyl Glucoside, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Passiflora Edulis Fruit Extract, Ethylhexylglycerin, Glyceryl Oleate, Vaccinium Macrocarpon (Cranberry) Seed Oil, Xanthan Gum, Cellulose Gum, Sodium Chloride, HippophaeRhamnoides Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Anthemis Nobilis Flower Oil, Cinnamomum Camphora Linalloliferum Wood Oil, Pelargonium Graveolens Flower Oil, Glucose, Parfum* (Fragrance), Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Rosmarinus Officinalis (Rosmary) Leaf Extract, Hydrogenated Palm Glycerides Citrate, Citric Acid, Sodium Hydroxide, Citronellol, Geraniol, Limonene, Linalool*100% Natural Fragrance - Parfum 100% Naturel

* Please review the disclaimer below.