JAFRA ROYAL LUNA BRIGHT KIT- avobenzone, homosalate, octisalate, octocrylene 
JAFRA COSMETICS INTERNATIONAL INC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Jafra Royal Luna Bright Kit

Active Ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Oxybenzone 7% Sunscreen

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. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if rash occurs.

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.

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 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

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

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)

Revised: 1/2019
Document Id: 4b32398b-2efc-444e-a499-d0c26c21c995
Set id: 1a2e453d-2ede-4366-b49e-00df39b69842
Version: 2
Effective Time: 20190115
 
JAFRA COSMETICS INTERNATIONAL INC