JAFRA ROYAL LUNA BRIGHT KIT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) KIT [JAFRA COSMETICS INTERNATIONAL INC]

JAFRA ROYAL LUNA BRIGHT KIT (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) KIT [JAFRA COSMETICS INTERNATIONAL INC]
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NDC 68828-285-01, 68828-286-01
Set ID 1a2e453d-2ede-4366-b49e-00df39b69842
Category HUMAN OTC DRUG LABEL
Packager JAFRA COSMETICS INTERNATIONAL INC
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 3% Sunscreen

    Homosalate 10% Sunscreen

    Octisalate 5% Sunscreen

    Oxybenzone 7% Sunscreen

  • PURPOSE

    Uses

    helps prevent sunburn
    if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • 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

    Warnings

    For external use only

    Do not use on damaged or broken skin

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

  • DOSAGE & ADMINISTRATION

    Directions

    apply liberally 15 minutes before sun exposure
    use a water resistant sunscreen if swimming or sweating
    reapply at least every 2 hours
    children under 6 months: Ask a doctor
    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and skin aging. to decrease

    this 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 ingredients

    Acrylates/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

  • PRINCIPAL DISPLAY PANEL

    Jafra Royal

    Royal Jelly

    Luna Bright

    Contains 4 samples

    1 Refining Gel Cleanser

    7.5ml .25 FL OZ

    1 Brightening Hydrogel Moisturizer

    7.5ml .25 FL OZ

    1 Brightening Serum Concentrate

    7.5ml .25 FL OZ

    1 Brightening Daily Protector Broad SpectrumSPF 30

    7.5ml .25 FL OZ

    Total Contents 30ml 1 FL OZ

    luna bright kit front

    luna bright kit back

  • INGREDIENTS AND APPEARANCE
    JAFRA ROYAL LUNA BRIGHT KIT 
    avobenzone, homosalate, octisalate, octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-285
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-285-011 in 1 KIT; Type 1: Convenience Kit of Co-Package01/09/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 7.5 
    Part 21 TUBE 7.5 
    Part 31 TUBE 7.5 
    Part 41 TUBE 7.5 mL
    Part 1 of 4
    BRIGHTENING SERUM CONCENTRATE 
    other skin care preparations
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRCAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    INGR1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    INGRPROPANEDIOL (UNII: 5965N8W85T)  
    INGRSODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRTRIDECETH-6 (UNII: 3T5PCR2H0C)  
    INGRPEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRDULSE (UNII: 7832HOY4ZQ)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRTREHALOSE (UNII: B8WCK70T7I)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRPOLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    INGRUREA (UNII: 8W8T17847W)  
    INGRTRIACETIN (UNII: XHX3C3X673)  
    INGRTOCOPHEROL (UNII: R0ZB2556P8)  
    INGREDETATE TRISODIUM (UNII: 420IP921MB)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    INGR.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRLINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.5 in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 2 of 4
    BRIGHTENING HYDROGEL MOISTURIZER 
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRDULSE (UNII: 7832HOY4ZQ)  
    INGRCYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGRCYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRTREHALOSE (UNII: B8WCK70T7I)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRPOLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    INGRUREA (UNII: 8W8T17847W)  
    INGRTRIACETIN (UNII: XHX3C3X673)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRPEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    INGRDISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    INGRBIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    INGRCARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRHYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.5 in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 3 of 4
    REFINING GEL CLEANSER 
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGRPEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRPEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    INGRCARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    INGRGLYCOL STEARATE (UNII: 0324G66D0E)  
    INGRWINE GRAPE JUICE (UNII: JHQ6158A7R)  
    INGRXANTHAN GUM (UNII: TTV12P4NEE)  
    INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRMICA (UNII: V8A1AW0880)  
    INGRBISMUTH OXYCHLORIDE (UNII: 4ZR792I587)  
    INGRCARMINIC ACID (UNII: CID8Z8N95N)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    INGRISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGR.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    INGR.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRLINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.5 in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 4 of 4
    BRIGHTENING DAILY PROTECTOR BROAD SPECTRUM SPF 30 
    avobenzone, homosalate, octisalate, octocrylene jelly
    Product Information
    Item Code (Source)NDC:68828-286
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-286-017.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart352
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/09/2019
    Labeler - JAFRA COSMETICS INTERNATIONAL INC (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-285, 68828-286)

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