NDC 62032-536 Obagi-c Fx System Normal-oily Skin Brightening System With Arbutin

Homosalate, Octisalate, And Zinc Oxide

NDC Product Code 62032-536

NDC CODE: 62032-536

Proprietary Name: Obagi-c Fx System Normal-oily Skin Brightening System With Arbutin 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: Homosalate, Octisalate, And Zinc Oxide 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.

NDC Code Structure

  • 62032 - Obagi Cosmeceuticals Llc

NDC 62032-536-57

Package Description: 1 KIT in 1 CARTON * 85 g in 1 TUBE (62032-142-11) * 177 mL in 1 BOTTLE, PLASTIC * 198 mL in 1 BOTTLE, PLASTIC * 57 g in 1 BOTTLE, PLASTIC * 1 BOTTLE, GLASS in 1 CARTON > 30 mL in 1 BOTTLE, GLASS

NDC Product Information

Obagi-c Fx System Normal-oily Skin Brightening System With Arbutin with NDC 62032-536 is a a human over the counter drug product labeled by Obagi Cosmeceuticals Llc. The generic name of Obagi-c Fx System Normal-oily Skin Brightening System With Arbutin is homosalate, octisalate, and zinc oxide. The product's dosage form is kit and is administered via form.

Labeler Name: Obagi Cosmeceuticals Llc

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)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • C15-19 ALKANE (UNII: CI87N1IM01)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Labeler Information

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

Labeler Name: Obagi Cosmeceuticals Llc
Labeler Code: 62032
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: 12-02-2019 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.

Obagi-c Fx System Normal-oily Skin Brightening System With Arbutin Product Label Images

Obagi-c Fx System Normal-oily Skin Brightening System With Arbutin 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

Other

Drug Facts

Distributed by Obagi Cosmeceuticals LLC, Long Beach, CA 90806

Otc - Purpose

Active ingredientsPurposeHomosalate 10%SunscreenOctisalate 5%SunscreenZinc Oxide 16.5%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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

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 exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hoursSun 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.–2 p.m.wear long-sleeved shirts, pants, hats, and sunglasseschildren under 6 months: Ask a doctor

Other Information

  • Store at controlled room temperature: 15°C–25°C (59°F–77°F)protect this product from excessive heat and direct sun

Inactive Ingredients

Water (Aqua), C15-19 Alkane, Octyldodecyl Neopentanoate, Polymethylsilsesquioxane, Sorbitan Olivate, Silica, Polyglyceryl-6 Polyrininoleate, Sodium Chloride, Xanthan Gum, Glycerin, Hydroxyacetophenone, Disodium EDTA, 1,2-Hexanediol, Caprylyl Glycol, Sodium Hydroxide, Triethoxycaprylsilane, Polyhydroxystearic Acid, Disteardimonium Hectorite, Polyglyceryl-2 Isostearate, Euphorbia Cerifera (candelilla) Wax, Beeswax, Dimethicone

* Please review the disclaimer below.