Label: JAFRA ROYAL JELLY REVITALIZE- avobenzone, homosalate, octisalate, octocrylene kit
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-500-01, 68828-501-01, 68828-501-02 - Packager: JAFRA COSMETICS INTERNATIONAL
- 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 April 20, 2018
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients Purpose
Avobenzone 3%..........................................................Sunscreen
Homosalate 10%.........................................................Sunscreen
Octisalate 5%..............................................................Sunscreen
Octocrylene 7%...........................................................Sunscreen - 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 early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection 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 AcrylateCrosspolymer, Acrylates/Dimethicone Copolymer, Actinidia Chinensis(Kiwi) Fruit Water, Alcohol,Allantoin, Aluminum Starch Octenylsuccinate, Arachidy lAlcohol, Arachidyl Glucoside, Arginine, Behenyl Alcohol, Benzyl Alcohol, Bisabolol, Butylene Glycol, Butyrospermum Parkii(Shea) Butter, Chlorphenesin, Cocos Nucifera Fruit Extract, Cyclopentasiloxane, Dipropylene Glycol, Disodium EDTA, Ethylhexylglycerin,Fragrance/Parfum, Glycerin,Glyceryl Stearate, Hydrogenated Lecithin, Lauroyl Lysine, Lecithin,Maltodextrin, Moringa Oleifera Leaf Extract, PEG-100 Stearate, Phenethyl Alcohol, Polygonum Aviculare Extract, Royal Jelly,Sodium Ascorbyl Phosphate,Sophora Flavescens Root Extract, Styrene/Acrylates Copolymer, Tetrapeptide-45,Water/Aqua - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
JAFRA ROYAL JELLY REVITALIZE
avobenzone, homosalate, octisalate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-500 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-500-01 1 in 1 PACKAGE; Type 0: Not a Combination Product 04/27/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 14 mL Part 2 1 PACKAGE 7.5 mL Part 3 1 TUBE 30 mL Part 4 1 TUBE 14 mL Part 1 of 4 SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Item Code (Source) NDC:68828-501 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 CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) KIWI FRUIT OIL (UNII: 66086CWP3Q) ALCOHOL (UNII: 3K9958V90M) ALLANTOIN (UNII: 344S277G0Z) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) ARGININE (UNII: 94ZLA3W45F) DOCOSANOL (UNII: 9G1OE216XY) BENZYL ALCOHOL (UNII: LKG8494WBH) LEVOMENOL (UNII: 24WE03BX2T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SHEA BUTTER (UNII: K49155WL9Y) CHLORPHENESIN (UNII: I670DAL4SZ) COCONUT (UNII: 3RT3536DHY) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIPROPYLENE GLYCOL (UNII: E107L85C40) EDETATE DISODIUM (UNII: 7FLD91C86K) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) LAUROYL LYSINE (UNII: 113171Q70B) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) MALTODEXTRIN (UNII: 7CVR7L4A2D) MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B) PEG-100 STEARATE (UNII: YD01N1999R) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) ROYAL JELLY (UNII: L497I37F0C) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-501-01 14 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68828-501-02 7.5 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 Part 2 of 4 SPOT SERUM
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR OCTYLDODECANOL (UNII: 461N1O614Y) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR KIWI FRUIT OIL (UNII: 66086CWP3Q) INGR SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) INGR GARDEN CRESS SPROUT (UNII: PWQ18YNR62) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR ROYAL JELLY (UNII: L497I37F0C) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) INGR SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) INGR DMDM HYDANTOIN (UNII: BYR0546TOW) INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) INGR COCONUT (UNII: 3RT3536DHY) INGR MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B) INGR EDETATE TRISODIUM (UNII: 420IP921MB) INGR ALCOHOL (UNII: 3K9958V90M) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR BENZYL SALICYLATE (UNII: WAO5MNK9TU) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR LINALOOL, (+)- (UNII: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 04/26/2018 Part 3 of 4 GENTLE CLEANSING MILK
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR DECYL GLUCOSIDE (UNII: Z17H97EA6Y) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) INGR COCO GLUCOSIDE (UNII: ICS790225B) INGR ROYAL JELLY (UNII: L497I37F0C) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR GLYCOL STEARATE (UNII: 0324G66D0E) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR BENZOIC ACID (UNII: 8SKN0B0MIM) INGR DEHYDROACETIC ACID (UNII: 2KAG279R6R) INGR ALLANTOIN (UNII: 344S277G0Z) INGR EDETATE SODIUM (UNII: MP1J8420LU) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) INGR POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR BENZYL SALICYLATE (UNII: WAO5MNK9TU) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR LINALOOL, (+)- (UNII: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 7.5 mL in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 4 of 4 LONGEVITY CREME
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) INGR POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) INGR ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW) INGR STEARYL STEARATE (UNII: 5WX2EGD0DK) INGR ROYAL JELLY (UNII: L497I37F0C) INGR HONEY (UNII: Y9H1V576FH) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR MYRISTYL MYRISTATE (UNII: 4042ZC00DY) INGR PALMITOYL GLYCINE (UNII: M6V3RIU5KI) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR SQUALENE (UNII: 7QWM220FJH) INGR ALFALFA (UNII: DJO934BRBD) INGR COCONUT OIL (UNII: Q9L0O73W7L) INGR TROLAMINE (UNII: 9O3K93S3TK) INGR EDETATE TRISODIUM (UNII: 420IP921MB) INGR PEG-4 LAURATE (UNII: AYF4VM3N1Z) INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR DMDM HYDANTOIN (UNII: BYR0546TOW) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR BENZYL SALICYLATE (UNII: WAO5MNK9TU) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR LINALOOL, (+)- (UNII: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 14 mL in 1 TUBE; Type 0: Not a Combination Product 2 7.5 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/27/2018 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V 814732061 manufacture(68828-500, 68828-501)
