NDC 68828-395 Jafra Royal Men Sample Set

Avobenzone, Homosalate

NDC Product Code 68828-395

NDC Code: 68828-395

Proprietary Name: Jafra Royal Men Sample Set 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: Avobenzone, Homosalate 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 International Cosmetics
    • 68828-395 - Jafra Royal Men Sample Set

NDC 68828-395-01

Package Description: 1 KIT in 1 KIT * 7.5 mL in 1 JAR * 25 mL in 1 JAR * 7.5 mL in 1 JAR * 7.5 mL in 1 JAR (68828-396-01)

NDC Product Information

Jafra Royal Men Sample Set with NDC 68828-395 is a a human over the counter drug product labeled by Jafra International Cosmetics. The generic name of Jafra Royal Men Sample Set is avobenzone, homosalate. The product's dosage form is kit and is administered via topical form.

Labeler Name: Jafra International Cosmetics

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.

  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • C13-16 ISOPARAFFIN (UNII: LED42LZG6O)
  • CAFFEINE (UNII: 3G6A5W338E)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)
  • PYRROLIDONE CARBOXYLIC ACID (UNII: 6VT1YZM21H)
  • TRIACETIN (UNII: XHX3C3X673)
  • UREA (UNII: 8W8T17847W)
  • WATER (UNII: 059QF0KO0R)
  • YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • TREHALOSE (UNII: B8WCK70T7I)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • COCOA (UNII: D9108TZ9KG)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SALIX ALBA BARK (UNII: 205MXS71H7)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • ARGININE (UNII: 94ZLA3W45F)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • CITRAL (UNII: T7EU0O9VPP)
  • .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
  • COUMARIN (UNII: A4VZ22K1WT)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • ALLANTOIN (UNII: 344S277G0Z)
  • BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • LIMONENE, (+)- (UNII: GFD7C86Q1W)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
  • LAUROYL LYSINE (UNII: 113171Q70B)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)

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 International Cosmetics
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: 04-09-2019 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.

Jafra Royal Men Sample Set Product Label Images

Jafra Royal Men Sample Set 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

Active Ingredients PurposeAvobenzone 3% SunscreenHomosalate 10% SunscreenOctisalate 5% SunscreenOctocrylene 10% Sunscreen

Otc - Purpose

  • UsesHelps 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

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Stop use and ask a doctor if rash occurs

Warnings

WarningsDo not use on damaged or broken skin
Whe using this product keep out of eyes. RInse with water to remove.

Dosage & Administration

  • DirectionsApply liberally 15 minutes before sun exposureReapply: after 80 minutes of swimming or sweatingImmediately after towel dryingAt 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 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10a.m. – 2p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredient

INGREDIENTS/INGREDIENTES: Water/Aqua, Glycerin, Cetearyl Alcohol, Ceteareth-20, Sodium Pca, Stearyl Stearate, Heptyl Undecylenate, C13-16 Isoparaffin, Dimethicone, Royal Jelly Powder, lecithin, Dipropylene Glycol, Royal Jelly, Tetrapeptide-45, Hydrogenated Lecithin, Sodium Hyaluronate, Hydroxyethyl Urea, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin,

Hexylene Glycol, Hydrolyzed Myrtus Communis Leaf Extract, Butylene Glycol, Rosa Canina Fruit Extract,

Palmaria Palmata (Red Seaweed) Extract, Triethanolamine, Myristyl Myristate, Sodium Acrylates Crosspolymer-2, Bis-Diglyceryl Polyacyladipate-2, Salix Alba (Willow) Bark Extract, Bisabolol, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Panthenol, Caffeine, Tocopheryl Acetate, Fragrance/Parfum, Butylphenyl Methylpropional (Lillial), Citral, Citronellol, Coumarin, Limonene, Linalool, Butyrospermum Parkii (Shea) Butter, Phenethyl Alcohol, Maltodextrin, Quercus Petraea Fruit Extract, Trisodium Edta.

* Please review the disclaimer below.

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