Label: JAFRA ROYAL LUNA BRIGHT KIT- avobenzone, homosalate, octisalate, octocrylene kit
- NDC Code(s): 68828-757-01, 68828-758-01
- Packager: JAFRA COSMETICS INTERNATIONAL INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 25, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient(s)
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
-
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 early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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, Phenethyl Alcohol, Polysorbate 60, Royal Jelly, Royal Jelly Powder, Silica, Sorbitan Isostearate, Styrene/Acrylates Copolymer, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Water/Aqua, Yeast Extract
- Other information
- Product label
-
INGREDIENTS AND APPEARANCE
JAFRA ROYAL LUNA BRIGHT KIT
avobenzone, homosalate, octisalate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-757 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-757-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 01/12/2022 05/01/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 7.5 mL Part 2 1 TUBE 7.5 mL Part 3 1 TUBE 7.5 mL Part 4 1 TUBE 7.5 mL Part 1 of 4 REFINING GEL CLEANSER
face and neck (excluding shaving preparations)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR DECYL GLUCOSIDE (UNII: Z17H97EA6Y) INGR PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) INGR COCO GLUCOSIDE (UNII: ICS790225B) INGR SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR ROYAL JELLY (UNII: L497I37F0C) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR GLYCOL STEARATE (UNII: 0324G66D0E) INGR WINE GRAPE JUICE (UNII: JHQ6158A7R) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR MICA (UNII: V8A1AW0880) INGR BISMUTH OXYCHLORIDE (UNII: 4ZR792I587) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) INGR .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 2 of 4 BRIGHTENING HYDROGEL MOISTURIZER
face and neck (excluding shaving preparations)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PALMARIA PALMATA (UNII: 7832HOY4ZQ) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR TREHALOSE (UNII: B8WCK70T7I) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR UREA (UNII: 8W8T17847W) INGR TRIACETIN (UNII: XHX3C3X673) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) INGR ROYAL JELLY (UNII: L497I37F0C) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR CYCLOMETHICONE 6 (UNII: XHK3U310BA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 3 of 4 BRIGHTENING SERUM CONCENTRATE
other skin care preparationsProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR GLYCERIN (UNII: PDC6A3C0OX) INGR WATER (UNII: 059QF0KO0R) INGR CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) INGR 1,2-HEXANEDIOL (UNII: TR046Y3K1G) INGR PROPANEDIOL (UNII: 5965N8W85T) INGR SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR TRIDECETH-6 (UNII: 3T5PCR2H0C) INGR PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) INGR ROYAL JELLY (UNII: L497I37F0C) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PALMARIA PALMATA (UNII: 7832HOY4ZQ) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR TREHALOSE (UNII: B8WCK70T7I) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR UREA (UNII: 8W8T17847W) INGR TRIACETIN (UNII: XHX3C3X673) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR EDETATE TRISODIUM (UNII: 420IP921MB) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) INGR .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 4 of 4 LUNA BRIGHT BRIGHTENING DAILY PROTECTOR BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Item Code (Source) NDC:68828-758 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-758-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 01/12/2022 Labeler - JAFRA COSMETICS INTERNATIONAL INC (041676479) Establishment Name Address ID/FEI Business Operations Distribuidora Comercial Jafra, S.A. de C.V. 951612777 manufacture(68828-757, 68828-758)
