Label: JAFRA ROYAL DEFY SAMPLE KIT- avobenzone, homosalate, octisalate, octocrylene kit
REVITALIZE SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream
JAFRA ROYAL DEFY TRAVEL KIT- avobenzone, homosalate, octisalate, octocrylene kit

  • NDC Code(s): 68828-511-01, 68828-512-01, 68828-513-01, 68828-514-01, view more
    68828-515-01
  • Packager: Jafra cosmetics International
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 2024

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

  • Active Ingredients

    Avobenzone 3%

    Homosalate 10%

    Octisalate 5%

    Octocrylene 7%

  • Purpose

    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.

  • Warnings

    For external use only

    Do not useon damaged or broken skin

    When using this productkeep out of eyes. Rinse with water to remove.

    Stop use and ask a doctorif rash occurs

  • 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.

  • Directions

    • apply generously and evenly 15 minutes before sun exposure
    • use a water-resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours.
    • children under 6 months of age: 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 your time in the sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

  • Inactive ingredients

    Water/Aqua, Styrene/Acrylates Copolymer, Aluminum Starch Octenylsuccinate, Ethylhexylglycerin, Benzyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Arachidyl Alcohol, Bisabolol, Behenyl Alcohol, Cyclopentasiloxane, Lauroyl Lysine, Arachidyl Glucoside, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Arginine, Chlorphenesin, Disodium EDTA, Acrylates/Dimethicone Copolymer, Royal Jelly Powder, Glycerin, Butyrospermum Parkii (Shea) Butter, Dipropylene Glycol, Sodium Ascorbyl Phosphate, Lecithin, Hydrogenated Lecithin, Royal Jelly, Polygonum Aviculare Extract, Phenethyl Alcohol, Cocos Nucifera (Coconut) Fruit Extract, Butylene Glycol, Actinidia Chinensis (Kiwi) Fruit Water, Moringa Oleifera Leaf Extract, Maltodextrin, Tetrapeptide-45, Alcohol, Sophora Flavescens Root Extract, Fragrance/Parfum, Benzyl Salicylate, Butylphenyl Methylpropional, Hydroxycitronellal, Limonene, Linalool

  • Other information

    Protect this product from excessive heat and direct sun

  • SPL UNCLASSIFIED SECTION

  • Product label

    image descriptionimage descriptionimage description

  • INGREDIENTS AND APPEARANCE
    JAFRA ROYAL DEFY SAMPLE KIT 
    avobenzone, homosalate, octisalate, octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-511
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-511-011 in 1 KIT; Type 1: Convenience Kit of Co-Package08/22/202212/31/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 7.5 mL
    Part 21 TUBE 7.5 mL
    Part 31 TUBE 7.5 mL
    Part 41 TUBE 7.5 mL
    Part 1 of 4
    GENTLE CLEANSING MILK 
    other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRPEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGRSTYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    INGRGLYCOL STEARATE (UNII: 0324G66D0E)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGREDETATE SODIUM (UNII: MP1J8420LU)  
    INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
    INGRDEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRSODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.5 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/22/2022
    Part 2 of 4
    SPOT SERUM 
    other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGROCTYLDODECANOL (UNII: 461N1O614Y)  
    INGRBIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    INGRSODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRKIWI FRUIT OIL (UNII: 66086CWP3Q)  
    INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
    INGRCOCONUT (UNII: 3RT3536DHY)  
    INGREDETATE TRISODIUM (UNII: 420IP921MB)  
    INGRSODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    INGRMORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)  
    INGRALCOHOL (UNII: 3K9958V90M)  
    INGRSOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRGARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.5 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/22/2022
    Part 3 of 4
    LONGEVITY CREME 
    other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPOLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)  
    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)  
    INGRPENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRHONEY (UNII: Y9H1V576FH)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    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)  
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    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)  
    INGRHYDROXYCITRONELLOL (UNII: R0B4U2I48W)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.5 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/26/2022
    Part 4 of 4
    REVITALIZE SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Item Code (Source)NDC:68828-512
    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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    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 ANHYDROUS (UNII: 8NLQ36F6MM)  
    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)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-512-017.5 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 DrugM02008/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/22/2022
    REVITALIZE SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-515
    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 INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    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 ANHYDROUS (UNII: 8NLQ36F6MM)  
    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)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-515-011 in 1 CARTON08/22/2022
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/22/2022
    JAFRA ROYAL DEFY TRAVEL KIT 
    avobenzone, homosalate, octisalate, octocrylene kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-513
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-513-011 in 1 KIT; Type 1: Convenience Kit of Co-Package08/22/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 30 mL
    Part 21 TUBE 7.5 mL
    Part 31 TUBE 14 mL
    Part 41 TUBE 14 mL
    Part 1 of 4
    GENTLE CLEANSING MILK 
    other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)]
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRPEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    INGRCOCO GLUCOSIDE (UNII: ICS790225B)  
    INGRDECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGRSTYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    INGRSODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    INGRGLYCOL STEARATE (UNII: 0324G66D0E)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRALLANTOIN (UNII: 344S277G0Z)  
    INGREDETATE SODIUM (UNII: MP1J8420LU)  
    INGRBENZOIC ACID (UNII: 8SKN0B0MIM)  
    INGRDEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    INGRSODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRPOLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/22/2022
    Part 2 of 4
    SPOT SERUM 
    other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)]
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGROCTYLDODECANOL (UNII: 461N1O614Y)  
    INGRBIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)  
    INGRSODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRKIWI FRUIT OIL (UNII: 66086CWP3Q)  
    INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
    INGRCOCONUT (UNII: 3RT3536DHY)  
    INGREDETATE TRISODIUM (UNII: 420IP921MB)  
    INGRSODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    INGRMORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B)  
    INGRALCOHOL (UNII: 3K9958V90M)  
    INGRSOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGRGARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
    INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    17.5 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/22/2022
    Part 3 of 4
    LONGEVITY CREME 
    other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)]
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRPOLYISOBUTYLENE (800000 MW) (UNII: Y132ZOQ9H7)  
    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)  
    INGRPENTAERYTHRITYL DISTEARATE (UNII: 697WOT8HNB)  
    INGRROYAL JELLY (UNII: L497I37F0C)  
    INGRHONEY (UNII: Y9H1V576FH)  
    INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    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)  
    INGRCOCONUT OIL (UNII: Q9L0O73W7L)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRCARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    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)  
    INGRHYDROXYCITRONELLOL (UNII: R0B4U2I48W)  
    INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    114 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic01/13/2022
    Part 4 of 4
    REVITALIZE SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Item Code (Source)NDC:68828-514
    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) OCTOCRYLENE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    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 ANHYDROUS (UNII: 8NLQ36F6MM)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    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)  
    STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-514-0114 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 DrugM02008/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/22/2022
    Labeler - Jafra cosmetics International (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-511, 68828-512, 68828-513, 68828-514, 68828-515)