NDC 10967-639 Revlon Youth Fx

Zinc Oxide, Titanium Dioxide Make-up

NDC Product Code 10967-639

NDC 10967-639-01

Package Description: 30 mL in 1 TUBE

NDC Product Information

Revlon Youth Fx with NDC 10967-639 is a a human over the counter drug product labeled by Revlon Consumer Products Corp. The generic name of Revlon Youth Fx is zinc oxide, titanium dioxide make-up. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Revlon Consumer Products Corp

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Revlon Youth Fx 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.

  • ZINC OXIDE 2.8 mg/30mL
  • TITANIUM DIOXIDE 4.3 mg/30mL

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)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • PEG/PPG-19/19 DIMETHICONE (UNII: EHH90CO7TL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
  • TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • SEA SALT (UNII: 87GE52P74G)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • TRISILOXANE (UNII: 9G1ZW13R0G)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)

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: Revlon Consumer Products Corp
Labeler Code: 10967
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: 09-19-2019 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’.

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Revlon Youth Fx Product Label Images

Revlon Youth Fx 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 4.3%Zinc Oxide 2.8Purpose:Sunscreen

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 only Do notuse 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 a 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 exposureUse a water resistant sunscreen if swimming or sweatingReapply at least every 2 hoursChildren under 6 months: Ask a doctor.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 sun protection measures including: Limit time in the sun, especially from 10 am - 2 pmWear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients:

Dimethicone, Cyclopentasiloxane, Aqua (Water (Eau)), PEG/PPG-19/19 Dimethicone, C13-16 Isoparaffin, Trimethylsiloxysilicate, Isohexadecane, Dimethicone Crosspolymer, Stearyl Heptanoate, Boron Nitride, Tribehenin, Stearyl Caprylate, C10-13 Isoparaffin, Maris Sal ((Sea Salt) Sel Marin), Tocopherol, Niacinamide, Sodium Ascorbyl Phosphate, Tocopheryl Acetate, Sodium Carrageenan, Saccharide Isomerate, Glycerin, Trisiloxane, Alumina, Methicone, Triethoxycaprylylsilane, Polymethylsilsesquioxane, Sodium Chloride, Dimethicone/Vinyl Dimethicone Crosspolymer, HDI/Trimethylol Hexyllactone Crosspolymer, Sorbitan Sesquioleate, Tetrasodium EDTA, Phenoxyethanol, 1,2-Hexanediol, Caprylyl GlycolMay Contain Mica, Titanium Dioxide (Ci 77891), Iron Oxides (CI 77491, 77492, 77499)

* Please review the disclaimer below.