Label: JAFRA ROYAL DEFY SAMPLE KIT- avobenzone, homosalate, octisalate, octocrylene kit
ROYAL DEFY MULTI-PERFORMANCE AGE PROTECTOR BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion
JAFRA ROYAL DEFY TRAVEL KIT- avobenzone, homosalate, octisalate, octocrylene kit
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NDC Code(s):
68828-760-01,
68828-761-01,
68828-762-01,
68828-763-01, view more68828-764-01
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Uses
- Warnings
- KEEP OUT OF REACH OF CHILDREN
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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
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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
- SPL UNCLASSIFIED SECTION
- Product label
-
INGREDIENTS AND APPEARANCE
JAFRA ROYAL DEFY SAMPLE KIT
avobenzone, homosalate, octisalate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-760 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-760-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 01/13/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 7.5 mL Part 2 1 TUBE 7.5 mL Part 3 1 TUBE 7.5 mL Part 4 1 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 Kind Ingredient Name Quantity INGR CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL) INGR HYALURONIC ACID (UNII: S270N0TRQY) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR SOYBEAN (UNII: L7HT8F1ZOD) INGR CERAMIDE NP (UNII: 4370DF050B) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR AVOCADO OIL (UNII: 6VNO72PFC1) INGR OLIVE OIL (UNII: 6UYK2W1W1E) INGR BENZYL SALICYLATE (UNII: WAO5MNK9TU) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR WATER (UNII: 059QF0KO0R) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) INGR LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR ROYAL JELLY (UNII: L497I37F0C) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR METHYL GLUCETH-20 (UNII: J3QD0LD11P) INGR DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) INGR ACETYL TETRAPEPTIDE-11 (UNII: 0R3VC3BV8I) INGR ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CAFFEINE (UNII: 3G6A5W338E) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/13/2022 Part 2 of 4 4D DEFINING HYDRATOR
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR XYLITOL (UNII: VCQ006KQ1E) INGR XYLITYLGLUCOSIDE (UNII: O0IEZ166FB) INGR ANHYDROXYLITOL (UNII: 8XWR7NN42F) INGR OCTYLDODECANOL (UNII: 461N1O614Y) INGR OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM) INGR PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) INGR AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) INGR ETHYLHEXYL PALMITATE (UNII: 2865993309) INGR CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) INGR CAFFEINE (UNII: 3G6A5W338E) INGR DEXTRAN 40 (UNII: K3R6ZDH4DU) INGR TRIFLUOROACETYL TRIPEPTIDE-2 (UNII: E6WT9V3SGO) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889) INGR SOYBEAN (UNII: L7HT8F1ZOD) INGR CERAMIDE NP (UNII: 4370DF050B) INGR AVOCADO OIL (UNII: 6VNO72PFC1) INGR OLIVE OIL (UNII: 6UYK2W1W1E) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) INGR JOJOBA OIL (UNII: 724GKU717M) INGR CERAMIDE NG (UNII: C04977SRJ5) INGR PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR TRIBEHENIN (UNII: 8OC9U7TQZ0) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR ROYAL JELLY (UNII: L497I37F0C) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR BENZYL SALICYLATE (UNII: WAO5MNK9TU) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/13/2022 Part 3 of 4 RICH CREME CLEANSER
other skin care preparations, leave-on [skin care preparations (creams, lotions, powder, and sprays)] creamProduct Information Route of Administration TOPICAL Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR STEARYL HEPTANOATE (UNII: 2M4UGL1NCN) INGR STEARYL CAPRYLATE (UNII: 06TS6O9194) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) INGR ISOHEXADECANE (UNII: 918X1OUF1E) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR ROYAL JELLY (UNII: L497I37F0C) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR AVOCADO OIL (UNII: 6VNO72PFC1) INGR OLIVE OIL (UNII: 6UYK2W1W1E) INGR SOYBEAN (UNII: L7HT8F1ZOD) INGR CERAMIDE NP (UNII: 4370DF050B) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/13/2022 Part 4 of 4 ROYAL DEFY MULTI-PERFORMANCE AGE PROTECTOR BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Item Code (Source) NDC:68828-761 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-761-01 7.5 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/12/2022 ROYAL DEFY MULTI-PERFORMANCE AGE PROTECTOR BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-764 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-764-01 50 mL in 1 CARTON; Type 0: Not a Combination Product 01/12/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/12/2022 JAFRA ROYAL DEFY TRAVEL KIT
avobenzone, homosalate, octisalate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-762 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-762-01 1 in 1 KIT; Type 1: Convenience Kit of Co-Package 01/13/2022 11/30/2023 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 7.5 mL Part 2 1 TUBE 14 mL Part 3 1 TUBE 30 mL Part 4 1 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 Kind Ingredient Name Quantity INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CAFFEINE (UNII: 3G6A5W338E) INGR NIACINAMIDE (UNII: 25X51I8RD4) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL) INGR HYALURONIC ACID (UNII: S270N0TRQY) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR SOYBEAN (UNII: L7HT8F1ZOD) INGR CERAMIDE NP (UNII: 4370DF050B) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR AVOCADO OIL (UNII: 6VNO72PFC1) INGR OLIVE OIL (UNII: 6UYK2W1W1E) INGR BENZYL SALICYLATE (UNII: WAO5MNK9TU) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR WATER (UNII: 059QF0KO0R) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR BIS-PEG-18 METHYL ETHER DIMETHYL SILANE (UNII: OEB4R3WW9C) INGR LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR SILICON DIOXIDE (UNII: ETJ7Z6XBU4) INGR POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR ROYAL JELLY (UNII: L497I37F0C) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR METHYL GLUCETH-20 (UNII: J3QD0LD11P) INGR DIMETHYL ISOSORBIDE (UNII: SA6A6V432S) INGR ACETYL TETRAPEPTIDE-11 (UNII: 0R3VC3BV8I) INGR ACETYL TETRAPEPTIDE-9 (UNII: VMO8OOD3V0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/13/2022 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 Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR XYLITOL (UNII: VCQ006KQ1E) INGR XYLITYLGLUCOSIDE (UNII: O0IEZ166FB) INGR ANHYDROXYLITOL (UNII: 8XWR7NN42F) INGR OCTYLDODECANOL (UNII: 461N1O614Y) INGR OCTYLDODECYL XYLOSIDE (UNII: 8Z6VNR46QM) INGR PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO) INGR AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) INGR ETHYLHEXYL PALMITATE (UNII: 2865993309) INGR CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) INGR CAFFEINE (UNII: 3G6A5W338E) INGR DEXTRAN 40 (UNII: K3R6ZDH4DU) INGR TRIFLUOROACETYL TRIPEPTIDE-2 (UNII: E6WT9V3SGO) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR ISOSORBIDE DICAPRYLATE (UNII: 0IK29C4889) INGR SOYBEAN (UNII: L7HT8F1ZOD) INGR CERAMIDE NP (UNII: 4370DF050B) INGR AVOCADO OIL (UNII: 6VNO72PFC1) INGR OLIVE OIL (UNII: 6UYK2W1W1E) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) INGR HEXYLENE GLYCOL (UNII: KEH0A3F75J) INGR MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) INGR JOJOBA OIL (UNII: 724GKU717M) INGR CERAMIDE NG (UNII: C04977SRJ5) INGR PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR TRIBEHENIN (UNII: 8OC9U7TQZ0) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR ROYAL JELLY (UNII: L497I37F0C) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR BENZYL SALICYLATE (UNII: WAO5MNK9TU) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 14 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/13/2022 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 Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR DIMETHICONE (UNII: 92RU3N3Y1O) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR PEG-100 STEARATE (UNII: YD01N1999R) INGR SHEA BUTTER (UNII: K49155WL9Y) INGR STEARYL HEPTANOATE (UNII: 2M4UGL1NCN) INGR STEARYL CAPRYLATE (UNII: 06TS6O9194) INGR CETYL ALCOHOL (UNII: 936JST6JCN) INGR HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) INGR ISOHEXADECANE (UNII: 918X1OUF1E) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR XANTHAN GUM (UNII: TTV12P4NEE) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) INGR EDETATE DISODIUM (UNII: 7FLD91C86K) INGR HYALURONATE SODIUM (UNII: YSE9PPT4TH) INGR ROYAL JELLY (UNII: L497I37F0C) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR DIPROPYLENE GLYCOL (UNII: E107L85C40) INGR TOCOPHEROL (UNII: R0ZB2556P8) INGR AVOCADO OIL (UNII: 6VNO72PFC1) INGR OLIVE OIL (UNII: 6UYK2W1W1E) INGR SOYBEAN (UNII: L7HT8F1ZOD) INGR CERAMIDE NP (UNII: 4370DF050B) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic 01/13/2022 Part 4 of 4 ROYAL DEFY AGE AND POLLUTION PROTECTOR BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene lotionProduct Information Item Code (Source) NDC:68828-763 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-763-01 14 mL in 1 TUBE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/13/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/12/2022 Labeler - Jafra cosmetics International (041676479) Establishment Name Address ID/FEI Business Operations Distribuidora Comercial Jafra, S.A. de C.V. 951612777 manufacture(68828-760, 68828-761, 68828-762, 68828-763, 68828-764)
