Label: ROYAL JELLY KIT JAFRA- avobenzone, homosalate, octisalate, octocrylene kit
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-242-01, 68828-243-01 - Packager: JAFRA COSMETICS INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 22, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
apply liberally 15 minutes before sun exposure
Use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
Children under 6 months: 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 time in the sun, especially 10a.m. - 2 p.m.
wear long-sleeve shirts, pants, hats and sunglasses
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INACTIVE INGREDIENT
Inactive ingredients
Water/Aqua, Styrene/Acrylates Copolymer, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Lauroyl Lysine, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside,Ethylhexylglycerin, Benzyl Alcohol, Bisabolol, Royal Jelly, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, Cocos Nucifera, Moringa Oleifera, Fragrance/Parfum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Allantoin, Arginine, Chlorphenesin, Cichorium Intybus (Chicory) Root Extract, Kappaphycus Alvarezii Extract, Glycerin, Polygonum Aviculare Extract, Sodium Ascorbyl Phosphate, Benzyl Salicylate, Limonene, Hydroxycitronellal, Butylphenyl Methylpropional (Lillial), Linalool
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROYAL JELLY KIT JAFRA
avobenzone, homosalate, octisalate, octocrylene kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-242 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-242-01 1 in 1 KIT; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 08/13/2015 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 15 mL Part 2 1 BOTTLE 7.5 mL Part 3 1 BOTTLE 7.5 mL Part 1 of 3 SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Item Code (Source) NDC:68828-243 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 7 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) LAUROYL LYSINE (UNII: 113171Q70B) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) BENZYL ALCOHOL (UNII: LKG8494WBH) LEVOMENOL (UNII: 24WE03BX2T) ROYAL JELLY (UNII: L497I37F0C) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) COCONUT (UNII: 3RT3536DHY) MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B) EDETATE DISODIUM (UNII: 7FLD91C86K) ALLANTOIN (UNII: 344S277G0Z) ARGININE (UNII: 94ZLA3W45F) CHLORPHENESIN (UNII: I670DAL4SZ) CHICORY ROOT (UNII: 090CTY533N) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) GLYCERIN (UNII: PDC6A3C0OX) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) BENZYL SALICYLATE (UNII: WAO5MNK9TU) LIMONENE, (+)- (UNII: GFD7C86Q1W) HYDROXYCITRONELLOL (UNII: R0B4U2I48W) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) LINALOOL, (+)- (UNII: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-243-01 15 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/13/2015 Part 2 of 3 GENTLE CLEANSING MILK
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR DECYL GLUCOSIDE (UNII: Z17H97EA6Y) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) INGR COCO GLUCOSIDE (UNII: ICS790225B) INGR SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU) INGR ROYAL JELLY (UNII: L497I37F0C) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I) INGR GLYCOL STEARATE (UNII: 0324G66D0E) INGR DMDM HYDANTOIN (UNII: BYR0546TOW) INGR EDETATE SODIUM (UNII: MP1J8420LU) INGR ALLANTOIN (UNII: 344S277G0Z) INGR COCONUT (UNII: 3RT3536DHY) INGR MORINGA OLEIFERA LEAF (UNII: 4WET1AWO9B) INGR CAPRYLYL GLYCOL (UNII: 00YIU5438U) INGR SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) INGR BENZYL SALICYLATE (UNII: WAO5MNK9TU) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR LINALOOL, (+)- (UNII: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Part 3 of 3 GLOBAL LONGEVITY BALM
cleansing (cold creams, cleansing lotions, liquids, and pads)Product Information Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER (UNII: 059QF0KO0R) INGR HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) INGR SQUALANE (UNII: GW89575KF9) INGR POLYSORBATE 60 (UNII: CAL22UVI4M) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR PENTYLENE GLYCOL (UNII: 50C1307PZG) INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) INGR HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) INGR ROYAL JELLY (UNII: L497I37F0C) INGR SACCHARIDE ISOMERATE (UNII: W8K377W98I) INGR CHICORY ROOT (UNII: 090CTY533N) INGR HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W) INGR PALMITOYL GLYCINE (UNII: M6V3RIU5KI) INGR ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) INGR MALTODEXTRIN (UNII: 7CVR7L4A2D) INGR POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) INGR C13-14 ISOPARAFFIN (UNII: E4F12ROE70) INGR LAURETH-7 (UNII: Z95S6G8201) INGR CYCLOMETHICONE (UNII: NMQ347994Z) INGR DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y) INGR WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082) INGR NELUMBO NUCIFERA FLOWER (UNII: 61W322NLDV) INGR LENTIL (UNII: 6O38V6B52O) INGR EDETATE TRISODIUM (UNII: 420IP921MB) INGR PANTHENOL (UNII: WV9CM0O67Z) INGR VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) INGR ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR ASCORBYL PALMITATE (UNII: QN83US2B0N) INGR HONEY (UNII: Y9H1V576FH) INGR LECITHIN, SOYBEAN (UNII: 1DI56QDM62) INGR ARGININE (UNII: 94ZLA3W45F) INGR DMDM HYDANTOIN (UNII: BYR0546TOW) INGR PEG-4 LAURATE (UNII: AYF4VM3N1Z) INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) INGR BENZYL SALICYLATE (UNII: WAO5MNK9TU) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W) INGR HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) INGR BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) INGR LINALOOL, (+)- (UNII: F4VNO44C09) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 7.5 mL in 1 BOTTLE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Cosmetic Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 08/13/2015 Labeler - JAFRA COSMETICS INTERNATIONAL (041676479) Registrant - JAFRA COSMETICS INTERNATIONAL (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-243, 68828-242)
