Label: CALMING DYNAMICS KIT JAFRA- calming testers

  • NDC Code(s): 68828-152-01
  • Packager: Jafra Cosmetics International Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 2.5 % Sunscreen

    Octinoxate 7.0 % Sunscreen

    Octisalate 4.0 % Sunscreen

    Oxybenzone 1.0% Sunscreen

    Uses

    Helps prevent sunnburn

    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.

    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 project keep out of eyes. Rinse with water to remove.

    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 from 10 a.m. - 2 p.m.

    wear long-sleeve shirts, pants, hats and sunglasses

    Inactive ingredients: Water/aqua, C12-15 Alkyl Benzoate, Hydroxyethyl Acrylate/ Sodium Acryloyl dimethyltaurate Copolymer, Squalane, Polysorbate 60, Tridecyl Neopentanoate, Aluminum starch Octenylsuccinate, Saccharide Isomerate, Polyacrylamide, C13-14 Isoparrafin, Laureth-7, Butylene Glycol, Avena Sativa (Oat) Kernel Extract, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Hemidesmus Indicus Extract, Phyllanthus Emblica Extract, Glycrrhiza Glabra (licorice) Extract, Biosaccharide Gum-4, Chondrus Crispus (Carrageenan) Extract, Panthenol, Tocopheryl Acetate, Dimethicone, Pueraria Lobata Root Extract, Trisodium EDTA, Pentylene Glycol, Propamidobenzoic acid.

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  • PRINCIPAL DISPLAY PANEL

    image of carton frontimage of carton back


    Jafra

    Calming Dynamics

    Tester

    Contains:4 samples

    1 Gentle Hydrating Night Cream/ 1 Gentle Cleansing Lotion/ 1 Gentle Soothing Toner/ 1 Gentle Hydrating Day Cream Broad Spectrum SPF 15

    Cont. Net. 60 ml 2 Fl Oz (US)

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  • INGREDIENTS AND APPEARANCE
    CALMING DYNAMICS KIT  JAFRA
    calming testers kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-152
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-152-01 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE 7.4 mL
    Part 2 1 TUBE 7.4 mL
    Part 3 1 BOTTLE 7.4 mL
    Part 4 1 BOTTLE 7.4 mL
    Part 1 of 4
    GENTLE HYDRATING DAY BROAD SPECTRUM SPF 15  JAFRA
    avobenzone, octinoxate, octisalate, oxybenzone cream
    Product Information
    Item Code (Source) NDC:68828-153
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.0 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 1.0 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    SQUALANE (UNII: GW89575KF9)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    OAT (UNII: Z6J799EAJK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LICORICE (UNII: 61ZBX54883)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 7.4 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/14/2012
    Part 2 of 4
    GENTLE HYDRATING NIGHT  JAFRA
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER (UNII: 059QF0KO0R)  
    INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGR ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGR POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    INGR C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    INGR LAURETH-7 (UNII: Z95S6G8201)  
    INGR LICORICE (UNII: 61ZBX54883)  
    INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGR OAT (UNII: Z6J799EAJK)  
    INGR CETYL ALCOHOL (UNII: 936JST6JCN)  
    INGR PANTHENOL (UNII: WV9CM0O67Z)  
    INGR DIMETHICONE (UNII: 92RU3N3Y1O)  
    INGR TOCOPHEROL (UNII: R0ZB2556P8)  
    INGR GINGER (UNII: C5529G5JPQ)  
    INGR LEVOMENOL (UNII: 24WE03BX2T)  
    INGR XYLITOL (UNII: VCQ006KQ1E)  
    INGR DMDM HYDANTOIN (UNII: BYR0546TOW)  
    INGR PEG-4 LAURATE (UNII: AYF4VM3N1Z)  
    INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGR EDETATE TRISODIUM (UNII: 420IP921MB)  
    INGR TANGERINE PEEL (UNII: JU3D414057)  
    INGR PUMMELO (UNII: ET1TN5W71X)  
    INGR PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
    INGR ORANGE PEEL (UNII: TI9T76XD44)  
    INGR DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 7.4 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 11/14/2012
    Part 3 of 4
    GENTLE CLEANSING  JAFRA
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER (UNII: 059QF0KO0R)  
    INGR ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)  
    INGR ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGR GLYCERIN (UNII: PDC6A3C0OX)  
    INGR POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    INGR HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)  
    INGR SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    INGR DMDM HYDANTOIN (UNII: BYR0546TOW)  
    INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGR ALLANTOIN (UNII: 344S277G0Z)  
    INGR PANTHENOL (UNII: WV9CM0O67Z)  
    INGR TOCOPHEROL (UNII: R0ZB2556P8)  
    INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGR OAT (UNII: Z6J799EAJK)  
    INGR LICORICE (UNII: 61ZBX54883)  
    INGR EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 7.4 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 11/14/2012
    Part 4 of 4
    GENTLE SOOTHING TONER  JAFRA
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER (UNII: 059QF0KO0R)  
    INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGR GLYCERIN (UNII: PDC6A3C0OX)  
    INGR LICORICE (UNII: 61ZBX54883)  
    INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGR PANTHENOL (UNII: WV9CM0O67Z)  
    INGR ALLANTOIN (UNII: 344S277G0Z)  
    INGR HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    INGR OAT (UNII: Z6J799EAJK)  
    INGR POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGR DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGR EDETATE TRISODIUM (UNII: 420IP921MB)  
    INGR PUMMELO (UNII: ET1TN5W71X)  
    INGR PELARGONIUM GRAVEOLENS FLOWERING TOP (UNII: 1P36QZP48P)  
    INGR ORANGE PEEL (UNII: TI9T76XD44)  
    INGR DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 7.4 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 01/14/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 11/14/2012
    Labeler - Jafra Cosmetics International Inc (041676479)
    Registrant - Jafra Cosmetics International Inc (041676479)
    Establishment
    Name Address ID/FEI Business Operations
    Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-152, 68828-153)
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