Label: JAFRA ROYAL LUNA BRIGHT KIT- avobenzone, homosalate, octisalate, octocrylene kit
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-285-01, 68828-286-01 - 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 January 15, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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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 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
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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
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INGREDIENTS AND APPEARANCE
JAFRA ROYAL LUNA BRIGHT KIT
avobenzone, homosalate, octisalate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-285 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-285-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 01/09/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 7.5 Part 2 1 TUBE 7.5 Part 3 1 TUBE 7.5 Part 4 1 TUBE 7.5 mL Part 1 of 4 BRIGHTENING SERUM CONCENTRATE
other skin care preparationsProduct Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) 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 HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR DULSE (UNII: 7832HOY4ZQ) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR TREHALOSE (UNII: B8WCK70T7I) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) 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 ROYAL JELLY (UNII: L497I37F0C) 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: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 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 WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR DULSE (UNII: 7832HOY4ZQ) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR CYCLOMETHICONE 6 (UNII: XHK3U310BA) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR TREHALOSE (UNII: B8WCK70T7I) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J) INGR UREA (UNII: 8W8T17847W) INGR TRIACETIN (UNII: XHX3C3X673) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) INGR DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) INGR BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR ROYAL JELLY (UNII: L497I37F0C) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 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 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 HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM) INGR CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) 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 CARMINIC ACID (UNII: CID8Z8N95N) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR ROYAL JELLY (UNII: L497I37F0C) 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: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 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 BRIGHTENING DAILY PROTECTOR BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene jellyProduct Information Item Code (Source) NDC:68828-286 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:68828-286-01 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 01/09/2019 Labeler - JAFRA COSMETICS INTERNATIONAL INC (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-285, 68828-286)
