JAFRA ROYAL DEFY SAMPLE KIT- avobenzone, homosalate, octisalate, octocrylene 
REVITALIZE SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream 
JAFRA ROYAL DEFY TRAVEL KIT- avobenzone, homosalate, octisalate, octocrylene 
Jafra cosmetics International

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.

----------

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 use on damaged or broken skin

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

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Product label

image descriptionimage descriptionimage description

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-Package08/22/2022
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 
lotions, oils, powders, and creams 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 
lotions, oils, powders, and creams 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 
lotions, oils, powders, and creams 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 finalpart35208/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/22/2022
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 finalpart35208/22/2022
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 
lotions, oils, powders, and creams
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 
lotions, oils, powders, and creams
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 
lotions, oils, powders, and creams
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 finalpart35208/22/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/22/2022
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)

Revised: 10/2022
Document Id: eb6948f3-d3a3-3fdd-e053-2995a90afc1e
Set id: 29b3ee35-e849-4427-a455-37d92c4b995c
Version: 2
Effective Time: 20221019
 
Jafra cosmetics International