JAFRA ROYAL DEFY SAMPLE KIT- avobenzone, homosalate, octisalate, octocrylene 
ROYAL DEFY MULTI-PERFORMANCE AGE PROTECTOR BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion 
JAFRA ROYAL DEFY TRAVEL KIT- avobenzone, homosalate, octisalate, octocrylene 
Jafra cosmetics International

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Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

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.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Alumina, Butylene Glycol, Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide 3, Cerium Oxide, Dipropylene Glycol, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Fragrance/Parfum, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Seed Extract, Hexylene Glycol, Hydrogenated Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lecithin, Maltodextrin, Olea Europaea (Olive) Fruit Oil, PEG-100 Stearate, Persea Gratissima (Avocado) Oil, Phenethyl Alcohol, Phenoxyethanol, Phytosterols, Polyester-8, Polymethyl Methacrylate, Polysorbate 60, Potassium Sorbate, Royal Jelly Powder, Royal Jelly, Sodium Benzoate, Sodium Hyaluronate, Sodium PCA, Squalane, Styrene/Acrylates Copolymer, Sucrose Stearate, Tetrapeptide-45, Theobroma Cacao (Cocoa) Seed Extract, Tocopherol, Tocopheryl Acetate, Tuber Magnatum Extract, VP/Eicosene Copolymer, Water/Aqua, Xanthan Gum

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:68828-760
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-760-011 in 1 KIT; Type 1: Convenience Kit of Co-Package01/13/2022
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
ACTIVE FIRMING SERUM 
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)]
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
INGRHYALURONIC ACID (UNII: S270N0TRQY)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRSOYBEAN (UNII: L7HT8F1ZOD)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
INGRWATER (UNII: 059QF0KO0R)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRBIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
INGRLAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
INGRPOLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRROYAL JELLY (UNII: L497I37F0C)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRMETHYL GLUCETH-20 (UNII: J3QD0LD11P)  
INGRDIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
INGRACETYL TETRAPEPTIDE-11 (UNII: 0R3VC3BV8I)  
INGRACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRCAFFEINE (UNII: 3G6A5W338E)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
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
Cosmetic01/13/2022
Part 2 of 4
4D DEFINING HYDRATOR 
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)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRXYLITOL (UNII: VCQ006KQ1E)  
INGRXYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
INGRANHYDROXYLITOL (UNII: 8XWR7NN42F)  
INGROCTYLDODECANOL (UNII: 461N1O614Y)  
INGROCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)  
INGRPEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
INGRCHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
INGRCAFFEINE (UNII: 3G6A5W338E)  
INGRDEXTRAN 40 (UNII: K3R6ZDH4DU)  
INGRTRIFLUOROACETYL TRIPEPTIDE-2 (UNII: E6WT9V3SGO)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
INGRSOYBEAN (UNII: L7HT8F1ZOD)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGRMANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
INGRJOJOBA OIL (UNII: 724GKU717M)  
INGRCERAMIDE NG (UNII: C04977SRJ5)  
INGRPALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRTRIBEHENIN (UNII: 8OC9U7TQZ0)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRROYAL JELLY (UNII: L497I37F0C)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
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
Cosmetic01/13/2022
Part 3 of 4
RICH CREME CLEANSER 
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)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRSTEARYL HEPTANOATE (UNII: 2M4UGL1NCN)  
INGRSTEARYL CAPRYLATE (UNII: 06TS6O9194)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
INGRISOHEXADECANE (UNII: 918X1OUF1E)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRROYAL JELLY (UNII: L497I37F0C)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRSOYBEAN (UNII: L7HT8F1ZOD)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
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
Cosmetic01/13/2022
Part 4 of 4
ROYAL DEFY MULTI-PERFORMANCE AGE PROTECTOR BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Item Code (Source)NDC:68828-761
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
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
CERIC OXIDE (UNII: 619G5K328Y)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
WATER (UNII: 059QF0KO0R)  
COCOA (UNII: D9108TZ9KG)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SQUALANE (UNII: GW89575KF9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SOYBEAN (UNII: L7HT8F1ZOD)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ROYAL JELLY (UNII: L497I37F0C)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SHEA BUTTER (UNII: K49155WL9Y)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-761-017.5 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 DrugM02001/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/12/2022
ROYAL DEFY MULTI-PERFORMANCE AGE PROTECTOR BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-764
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
ALUMINUM OXIDE (UNII: LMI26O6933)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE NP (UNII: 4370DF050B)  
CERIC OXIDE (UNII: 619G5K328Y)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SOYBEAN (UNII: L7HT8F1ZOD)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PEG-100 STEARATE (UNII: YD01N1999R)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
ROYAL JELLY (UNII: L497I37F0C)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
SQUALANE (UNII: GW89575KF9)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
COCOA (UNII: D9108TZ9KG)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-764-0150 mL in 1 CARTON; Type 0: Not a Combination Product01/12/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/12/2022
JAFRA ROYAL DEFY TRAVEL KIT 
avobenzone, homosalate, octisalate, octocrylene kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-762
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-762-011 in 1 KIT; Type 1: Convenience Kit of Co-Package01/13/202211/30/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 7.5 mL
Part 21 TUBE 14 mL
Part 31 TUBE 30 mL
Part 41 TUBE 14 mL
Part 1 of 4
ACTIVE FIRMING SERUM 
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)]
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRCAFFEINE (UNII: 3G6A5W338E)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGRCARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
INGRHYALURONIC ACID (UNII: S270N0TRQY)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGRSOYBEAN (UNII: L7HT8F1ZOD)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
INGRWATER (UNII: 059QF0KO0R)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRDIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
INGRBUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRBIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C)  
INGRLAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRSILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
INGRPOLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRROYAL JELLY (UNII: L497I37F0C)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRMETHYL GLUCETH-20 (UNII: J3QD0LD11P)  
INGRDIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
INGRACETYL TETRAPEPTIDE-11 (UNII: 0R3VC3BV8I)  
INGRACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0)  
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
Cosmetic01/13/2022
Part 2 of 4
4D DEFINING HYDRATOR 
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)]
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRXYLITOL (UNII: VCQ006KQ1E)  
INGRXYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
INGRANHYDROXYLITOL (UNII: 8XWR7NN42F)  
INGROCTYLDODECANOL (UNII: 461N1O614Y)  
INGROCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM)  
INGRPEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)  
INGRAMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
INGRETHYLHEXYL PALMITATE (UNII: 2865993309)  
INGRCHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
INGRCAFFEINE (UNII: 3G6A5W338E)  
INGRDEXTRAN 40 (UNII: K3R6ZDH4DU)  
INGRTRIFLUOROACETYL TRIPEPTIDE-2 (UNII: E6WT9V3SGO)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889)  
INGRSOYBEAN (UNII: L7HT8F1ZOD)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
INGRHEXYLENE GLYCOL (UNII: KEH0A3F75J)  
INGRMANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)  
INGRJOJOBA OIL (UNII: 724GKU717M)  
INGRCERAMIDE NG (UNII: C04977SRJ5)  
INGRPALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRTRIBEHENIN (UNII: 8OC9U7TQZ0)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRROYAL JELLY (UNII: L497I37F0C)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRBENZYL SALICYLATE (UNII: WAO5MNK9TU)  
INGRLIMONENE, (+)- (UNII: GFD7C86Q1W)  
INGRHYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
INGRLINALOOL, (+/-)- (UNII: D81QY6I88E)  
INGRBUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
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 3 of 4
RICH CREME CLEANSER 
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)]
Product Information
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRSTEARYL HEPTANOATE (UNII: 2M4UGL1NCN)  
INGRSTEARYL CAPRYLATE (UNII: 06TS6O9194)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRHYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
INGRISOHEXADECANE (UNII: 918X1OUF1E)  
INGRPOLYSORBATE 60 (UNII: CAL22UVI4M)  
INGRSORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
INGRHYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRXANTHAN GUM (UNII: TTV12P4NEE)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRSODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRHYALURONATE SODIUM (UNII: YSE9PPT4TH)  
INGRROYAL JELLY (UNII: L497I37F0C)  
INGRPHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
INGRMALTODEXTRIN (UNII: 7CVR7L4A2D)  
INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
INGRDIPROPYLENE GLYCOL (UNII: E107L85C40)  
INGRTOCOPHEROL (UNII: R0ZB2556P8)  
INGRAVOCADO OIL (UNII: 6VNO72PFC1)  
INGROLIVE OIL (UNII: 6UYK2W1W1E)  
INGRSOYBEAN (UNII: L7HT8F1ZOD)  
INGRCERAMIDE NP (UNII: 4370DF050B)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRPOTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
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
Cosmetic01/13/2022
Part 4 of 4
ROYAL DEFY AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Item Code (Source)NDC:68828-763
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
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
SUCROSE STEARATE (UNII: 274KW0O50M)  
CERIC OXIDE (UNII: 619G5K328Y)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
CERAMIDE NP (UNII: 4370DF050B)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
WATER (UNII: 059QF0KO0R)  
COCOA (UNII: D9108TZ9KG)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SQUALANE (UNII: GW89575KF9)  
TOCOPHEROL (UNII: R0ZB2556P8)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
SOYBEAN (UNII: L7HT8F1ZOD)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
ROYAL JELLY (UNII: L497I37F0C)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SHEA BUTTER (UNII: K49155WL9Y)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-763-0114 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 DrugM02001/13/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/12/2022
Labeler - Jafra cosmetics International (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora Comercial Jafra, S.A. de C.V.951612777manufacture(68828-760, 68828-761, 68828-762, 68828-763, 68828-764)

Revised: 1/2024
Document Id: 0e976a75-d43a-72f2-e063-6394a90ab6b2
Set id: c3b265b1-ab84-4ea9-b283-c92f5a4cf461
Version: 7
Effective Time: 20240110
 
Jafra cosmetics International