NDC 68828-285 Jafra Royal Luna Bright Kit

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 68828-285

NDC Code: 68828-285

Proprietary Name: Jafra Royal Luna Bright Kit Additional informationCallout TooltipWhat 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, Octisalate, Octocrylene Additional informationCallout TooltipWhat 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.


Code Structure
  • 68828 - Jafra Cosmetics International Inc
    • 68828-285 - Jafra Royal Luna Bright Kit

NDC 68828-285-01

Package Description: 1 KIT in 1 KIT * 7.5 in 1 TUBE * 7.5 in 1 TUBE * 7.5 mL in 1 TUBE (68828-286-01) * 7.5 in 1 TUBE

NDC Product Information

Jafra Royal Luna Bright Kit with NDC 68828-285 is a a human over the counter drug product labeled by Jafra Cosmetics International Inc. The generic name of Jafra Royal Luna Bright Kit is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is kit and is administered via form.

Labeler Name: Jafra Cosmetics International Inc

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

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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)

Additional informationCallout TooltipAbout 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.

  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • LAUROYL LYSINE (UNII: 113171Q70B)
  • CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
  • ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • ARGININE (UNII: 94ZLA3W45F)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ALLANTOIN, (+)- (UNII: XDK458E1J9)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • DULSE (UNII: 7832HOY4ZQ)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • ROYAL JELLY (UNII: L497I37F0C)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • PEG-20 SORBITAN ISOSTEARATE (UNII: X958PZJ9ON)
  • COCOA (UNII: D9108TZ9KG)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)

Product Labeler Information

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Jafra Cosmetics International Inc
Labeler Code: 68828
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-09-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Luna Bright Kit Product Label Images

Jafra Royal Luna Bright Kit 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% SunscreenOxybenzone 7% 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 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

Directionsapply liberally 15 minutes before 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 skin aging. to decreasethis risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun measures including;limit time in the sun, especially from 10 a.m. - 2 p.m.wear long-sleeve shirts, pants, hats, and sunglasses

Inactive Ingredient

Inactive ingredientsAcrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Allantoin, Aluminum Starch octenylsuccinate, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Arginine, Benzyl Alcohol, Bisabolol, Butyrospermum Parkii (Shea) Butter, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Lauroyl Lysine, Hydrogenated Lecithin, Lecithin, Maltodextrin, PEG-100 stearate, Palmaria Palmata (red seaweed) extract, Phenoxyethanol, Phenenthyl Alcohol, Polysorbate, Royal Jelly, Royal Jelly Powder, Silica, Sorbitan Isostearate, Styrene/Acrylates Copolymer, Tetrapeptide-45 , Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Yeast Extract

* Please review the disclaimer below.

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