Label: CONTROL DYNAMICS KIT JAFRA- control dynamics tester

  • NDC Code(s): 68828-121-01, 68828-122-01
  • Packager: Jafra Cosmetics International Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 2.75% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 7.5% Sunscreen

    Oxybenzone 2% 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

    · Keep out of reach of children. If product is 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
    · Apply liberally 15 minutes before sun exposure
    · Reapply at least every 2 hours
    · Use a water resistant sunscreen if swimming or sweating
    · 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 broad spectrum SPF 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, Aluminum Starch Octenlsuccinate, Sodium Polyacrylate, Hydrogenated Polydecene, Trideceth-6, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Saccharide Isomerate, Decamethylcyclopentasiloxane, Azadirachta Indica Extract, Tagetus Erecta (African Marigold) Extract, Ipomoea Digitata (Fingerleaf Morning Glory) Extract, Butylene Glycol, Panthenol, Chondrus Crispus (carageenan) Extract, Biosaccharide Gum-4, Lysine Thiazolidine Carboxylate, DMDM Hydantoin, Tocopheryl Acetate, Trisodium EDTA, Malic Acid, Hydrolyzed Prunus Amygdalus Dulcis (Sweet Almond) Protein, Butyl Avocadate, Fragrance/Parfum, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Polysorbate 20, Ethoxylated Castor Oil, Blue 1/CI42090, Yellow 5/CI 19140, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid,Zingiber Officinale (Ginger) Extract, Bisabolol.

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  • PRINCIPAL DISPLAY PANEL

    carton back

    carton front

    Jafra

    Control Dynamics

    Tester

    Contains 4 samples

    1 Oil Control Gel Cleanser/1 Oil Control Purifying Toner/1 Mattifying Lotion Broad Spectrum SPF 15/1 Balancing Night Cream

    Cont. Net. 55 ml 1,85 Fl Oz (US)

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  • INGREDIENTS AND APPEARANCE
    CONTROL DYNAMICS KIT  JAFRA
    control dynamics tester kit
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-121
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-121-01 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 14 TUBE 100 mL
    Part 2 7 TUBE 7.4 mL
    Part 3 7 BOTTLE 7.4 mL
    Part 4 7 TUBE 7.4 mL
    Part 1 of 4
    MATTIFYING BROAD SPECTRUM SPF 15  JAFRA
    avbobenzone, octisalate, octovrylene, oxybenzone lotion
    Product Information
    Item Code (Source) NDC:68828-122
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2.75 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 2 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    LYSINE THIAZOLIDINE CARBOXYLATE (UNII: WUG63M652E)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    MALIC ACID (UNII: 817L1N4CKP)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    GINGER (UNII: C5529G5JPQ)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-122-01 7.4 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 01/22/2013
    Part 2 of 4
    OIL CONTROL CLEANSER  JAFRA
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER (UNII: 059QF0KO0R)  
    INGR SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGR DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    INGR PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    INGR DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    INGR PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    INGR CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGR DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGR SALICYLIC ACID (UNII: O414PZ4LPZ)  
    INGR DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    INGR ARGININE (UNII: 94ZLA3W45F)  
    INGR POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGR PANTHENOL (UNII: WV9CM0O67Z)  
    INGR ALLANTOIN (UNII: 344S277G0Z)  
    INGR SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGR EDETATE SODIUM (UNII: MP1J8420LU)  
    INGR CARBOCYSTEINE LYSINE (UNII: 1D1Y95PXXA)  
    INGR LYSINE THIAZOLIDINE CARBOXYLATE (UNII: WUG63M652E)  
    INGR TEA TREE OIL (UNII: VIF565UC2G)  
    INGR POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGR D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    INGR PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGR HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 01/22/2013
    Part 3 of 4
    OIL CONTROL PURIFYING TONER  JAFRA
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER (UNII: 059QF0KO0R)  
    INGR POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    INGR SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    INGR ARGININE (UNII: 94ZLA3W45F)  
    INGR SALICYLIC ACID (UNII: O414PZ4LPZ)  
    INGR CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGR DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGR PANTHENOL (UNII: WV9CM0O67Z)  
    INGR ALLANTOIN (UNII: 344S277G0Z)  
    INGR PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    INGR HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    INGR EDETATE TRISODIUM (UNII: 420IP921MB)  
    INGR CARBOCYSTEINE LYSINE (UNII: 1D1Y95PXXA)  
    INGR LYSINE THIAZOLIDINE CARBOXYLATE (UNII: WUG63M652E)  
    INGR MENTHOL (UNII: L7T10EIP3A)  
    INGR TEA TREE OIL (UNII: VIF565UC2G)  
    INGR DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    INGR D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 01/22/2013
    Part 4 of 4
    BALANCING NIGHT CREAM  JAFRA
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER (UNII: 059QF0KO0R)  
    INGR C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    INGR PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    INGR CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    INGR BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    INGR GLYCERIN (UNII: PDC6A3C0OX)  
    INGR GLYCERIN (UNII: PDC6A3C0OX)  
    INGR SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    INGR XYLITOL (UNII: VCQ006KQ1E)  
    INGR XYLITAN (UNII: 5KQL0CX6R6)  
    INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    INGR PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    INGR DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    INGR IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    INGR BENZOPHENONE-9 (UNII: 7925W14T4L)  
    INGR PANTHENOL (UNII: WV9CM0O67Z)  
    INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGR EDETATE TRISODIUM (UNII: 420IP921MB)  
    INGR MANGANESE CARBONATE (UNII: 9ZV57512ZM)  
    INGR HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    INGR GINGER (UNII: C5529G5JPQ)  
    INGR LEVOMENOL (UNII: 24WE03BX2T)  
    INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    INGR D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 1 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 01/22/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 01/22/2013
    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(68828-121, 68828-122)
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