Label: JAFRA ROYAL JELLY REVITALIZE- avobenzone, homosalate, octisalate, octocrylene kit

  • 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients                                                         Purpose
    Avobenzone 3%..........................................................Sunscreen
    Homosalate 10%.........................................................Sunscreen
    Octisalate 5%..............................................................Sunscreen
    Octocrylene 7%...........................................................Sunscreen

  • PURPOSE

    Uses

    • helps prevent sunburn
    • if used as directed with other sunprotection 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 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 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
  • 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

    Jafra Royal

    Royal Jelly

    Revitalize

    1 Gentle Cleansing Milk
    30 ml 1 FL OZ (US)
    1 Longevity Crème
    14 ml 0.47 FL OZ (US)
    1 Spot Serum
    7,5 ml .25 FL OZ (US)
    1 Solar Protection Fluid Broad Spectrum SPF 50
    14 ml 0.47 FL OZ (US)
    Contains: 4 Sample
    Total Content 65,5 ml 2.21 FL OZ (US)

    Tube Front

    Tube Back

  • INGREDIENTS AND APPEARANCE
    JAFRA ROYAL JELLY REVITALIZE 
    avobenzone, homosalate, octisalate, octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-500
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-500-011 in 1 PACKAGE; Type 0: Not a Combination Product04/27/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 14 mL
    Part 21 PACKAGE 7.5 mL
    Part 31 TUBE 30 mL
    Part 41 TUBE 14 mL
    Part 1 of 4
    SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Item Code (Source)NDC:68828-501
    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
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-501-0114 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68828-501-027.5 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart352
    Part 2 of 4
    SPOT SERUM 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGROCTYLDODECANOL (UNII: 461N1O614Y)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRKIWI FRUIT OIL (UNII: 66086CWP3Q)  
    INGRSOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    INGRGARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRBIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    INGRSODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
    INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGRCOCONUT (UNII: 3RT3536DHY)  
    INGRMORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)  
    INGREDETATE TRISODIUM (UNII: 420IP921MB)  
    INGRALCOHOL (UNII: 3K9958V90M)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGRLINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.5 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic04/26/2018
    Part 3 of 4
    GENTLE CLEANSING MILK 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRPEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRGLYCOL STEARATE (UNII: 0324G66D0E)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
    INGRDEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGREDETATE SODIUM (UNII: MP1J8420LU)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRSODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    INGRPOLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGRLINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    27.5 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Part 4 of 4
    LONGEVITY CREME 
    cleansing (cold creams, cleansing lotions, liquids, and pads)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPOLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
    INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    INGRPOLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRPENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGRDI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW)  
    INGRSTEARYL STEARATE (UNII: 5WX2EGD0DK)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRHONEY (UNII: Y9H1V576FH)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGRMYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    INGRPALMITOYL GLYCINE (UNII: M6V3RIU5KI)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRSQUALENE (UNII: 7QWM220FJH)  
    INGRALFALFA (UNII: DJO934BRBD)  
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGREDETATE TRISODIUM (UNII: 420IP921MB)  
    INGRPEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
    INGRVITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    INGRASCORBYL PALMITATE (UNII: QN83US2B0N)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGRLINALOOL, (+)- (UNII: F4VNO44C09)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114 mL in 1 TUBE; Type 0: Not a Combination Product
    27.5 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/27/2018
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V814732061manufacture(68828-500, 68828-501)