NDC 68828-255 Radiance Foundation Broad Spectrum Spf 20 - Nude Jafra

Octinoxate, Zinc Oxide

NDC Product Code 68828-255

NDC CODE: 68828-255

Proprietary Name: Radiance Foundation Broad Spectrum Spf 20 - Nude Jafra 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: Octinoxate, 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

  • 68828 - Jafra Cosmetics International
    • 68828-255 - Radiance Foundation Broad Spectrum Spf 20 - Nude

NDC 68828-255-02

Package Description: 1 TUBE in 1 BOX > 30 mL in 1 TUBE (68828-255-01)

NDC Product Information

Radiance Foundation Broad Spectrum Spf 20 - Nude Jafra with NDC 68828-255 is a a human over the counter drug product labeled by Jafra Cosmetics International. The generic name of Radiance Foundation Broad Spectrum Spf 20 - Nude Jafra is octinoxate, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Jafra Cosmetics International

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.

Radiance Foundation Broad Spectrum Spf 20 - Nude Jafra 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.

  • OCTINOXATE 3 g/100mL
  • ZINC OXIDE 6.8 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.

  • WATER (UNII: 059QF0KO0R)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • SQUALANE (UNII: GW89575KF9)
  • DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • BORON NITRIDE (UNII: 2U4T60A6YD)
  • ROYAL JELLY (UNII: L497I37F0C)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • DMDM HYDANTOIN (UNII: BYR0546TOW)
  • RICE BRAN (UNII: R60QEP13IC)
  • ROSEMARY (UNII: IJ67X351P9)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PEG-4 LAURATE (UNII: AYF4VM3N1Z)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)
  • CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: Jafra Cosmetics International
Labeler Code: 68828
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 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: 08-11-2015 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Radiance Foundation Broad Spectrum Spf 20 - Nude Jafra Product Label Images

Radiance Foundation Broad Spectrum Spf 20 - Nude Jafra 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

Otc - Active Ingredient

Octinoxate 3% .................. SunscreenZinc Oxide 6.8% ................ Sunscreen

Otc - Purpose

  • Useshelps prevent sunburnif used as directed with other sun protection measures (see Directions

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Stop use and ask a doctor if rash occurs

Warnings

  • WarningsFor external use onlyDo not use on damaged or broken skinwhen using this product keep out of eyes. Rinse with water to remove

Dosage & Administration

  • Apply liberally 15 minutes befor sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hourschildren under 6 months: Ask a doctorSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the this risk, regularly use a sunscreen with a Broad Spectrum SPF 15 or higher and other sun protection measures including:limit time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleev shirts, pants, hats, and sunglasses

Inactive Ingredient

Water/Aqua, Titanium Dioxide, Triethoxycaprylysilane, Caprylic Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Diemthicone, C12-15 Alkyl Benzoate, Phenyl Dimethicone, Phenyl Trimethicone, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Squalane, Di-PPG-3 Myristyl Ether Adipate Caprylyl Methicone, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Boron Nitride, Royal Jelly, Propanediol, Sodium Chloride, DMDM Hydantoin, Dextin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosamarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Panthenol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Withania Somniferia (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Biosacchardie Gum-4, Chondrus Crispus (Carrageenan) Extract, Smithsonite Extract, Iron Oxides/CI 77491/CI 77492/CI 77499

* Please review the disclaimer below.