JAFRA ROYAL JELLY REVITALIZE- 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.

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Jafra Royal Jelly Revitalize
Solar Protection Fluid Broad Spectrum SPF 50

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

Uses

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

Stop use and ask a doctor if rash occurs

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.

Directions

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

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

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)

Revised: 4/2018
Document Id: 0edd1517-15b3-4c57-ae00-27fe2a6cfc4e
Set id: c7d1cd2e-8830-41bb-8f3f-4a3257323f80
Version: 1
Effective Time: 20180420
 
JAFRA COSMETICS INTERNATIONAL