Label: JAFRA PRO- avobenzone, homosalate, octisalate, octocrylene

  • NDC Code(s): 68828-111-01, 68828-112-01
  • 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 04/13

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  • ACTIVE INGREDIENT

    Avobenzone 3% Sunscreen

    Homosalate 5% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 7% Sunscreen

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

    Stop use and ask a doctor if rash occurs

    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

    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 Value of 15 or higher and other sunscreen 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, Butylene Glycol, Sorbitan Laurate, Hydroxyethylcellulose, Acetyl Dipeptide-1, Cetyl Ester, Pentylene Glycol, Cetearyl Alcohol, Coco-glucoside, Microcrystalline Cellulose, Cellulose Gum, C20-22 Alkyl Phosphate, C20-22 Alcohols, Algae Extract, Pullulan, Niacinamide, Hydrolyzed Soy Protein, Zea Mays (corn) Kernel Extract, Xanthan Gum, Sodium Hyaluronate, Trehalose, Sodium PCA, Polyquaternium-51, Urea, Glycerin, Avena Sativa (Oat) Kernel Extract, Cocos Nucifera (Coconut) Oil, Cucumis Sativus (Cucumber) Fruit Extract, Santalum Album (Sandalwood) Wood Extract, Rose Extract, Pyrus Malus (Apple) Fruit Extract, Passiflora Incarnata Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Cananga Odorata Flower Extract, Cucumis Melo Cantalupensis Fruit Extract, Caprylic/Capric Triglyceride, Alaria Esculenta Extract, Yeast Amino Acids, Tricalcium Phosphate, Morinda Citrifolia Extract, Carica Papaya Extract, Glycyrrhiza Glabra (Licorice) Extract, Pichia Anomala Extract, Tripleurospermum Maritima Extract, Dipotassium Glycyrrhizate, Glycine Soja (Soybean) Oil, Arnica Montana Flower Extract, Tocopherol, DMDM Hydantoin, Hydrogenated Lecithin, Panthenol, Trisodium EDTA, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Menthyl Lactate, Benzylidene Dimethoxydimethylindanone

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  • PRINCIPAL DISPLAY PANEL

    image of carton backimage carton frontimage of insert pt 1image of insert pt 2

    Jafra Pro

    Multidimensional technology helps mimic the appearance of young skin

    Contains six tubes at 4 ml 0.13 Fl Oz (US) each

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  • INGREDIENTS AND APPEARANCE
    JAFRA PRO 
    avobenzone, homosalate, octisalate, octocrylene kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68828-111
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-111-01 1 in 1 KIT
    Quantity of Parts
    Part # Package Quantity Total Product Quantity
    Part 1 1 TUBE 4 mL
    Part 2 1 TUBE 4 mL
    Part 3 1 TUBE 4 mL
    Part 4 1 TUBE 4 mL
    Part 5 1 TUBE 4 mL
    Part 6 1 TUBE 4 mL
    Part 1 of 6
    JAFRA PRO  FACE LIFT SPF 20
    octocrylene, octisalate, homosalate, avobenzone cream
    Product Information
    Item Code (Source) NDC:68828-112
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE 0.28 g  in 100 mL
    OCTISALATE (OCTISALATE) OCTISALATE 0.2 g  in 100 mL
    HOMOSALATE (HOMOSALATE) HOMOSALATE 0.2 g  in 100 mL
    AVOBENZONE (AVOBENZONE) AVOBENZONE 0.12 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    BUTYLENE GLYCOL  
    SORBITAN MONOLAURATE  
    HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
    N-ACETYL DIPEPTIDE-1  
    PENTYLENE GLYCOL  
    CETOSTEARYL ALCOHOL  
    COCO GLUCOSIDE  
    CELLULOSE, MICROCRYSTALLINE  
    C20-22 ALKYL PHOSPHATE  
    C20-22 ALCOHOLS  
    PULLULAN  
    NIACINAMIDE  
    CORN  
    XANTHAN GUM  
    HYALURONATE SODIUM  
    TREHALOSE  
    SODIUM PYRROLIDONE CARBOXYLATE  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)  
    UREA  
    GLYCERIN  
    OAT  
    CUCUMBER  
    SANDALWOOD  
    APPLE  
    PASSIFLORA INCARNATA FRUIT  
    APRICOT  
    RASPBERRY  
    CANANGA ODORATA FLOWER  
    CANTALOUPE  
    MEDIUM-CHAIN TRIGLYCERIDES  
    ALARIA ESCULENTA  
    TRICALCIUM PHOSPHATE  
    MORINDA CITRIFOLIA LEAF  
    PAPAYA  
    LICORICE  
    CELLULOSE, MICROCRYSTALLINE  
    CARBOXYMETHYLCELLULOSE SODIUM  
    GLYCYRRHIZINATE DIPOTASSIUM  
    SOYBEAN OIL  
    ARNICA MONTANA FLOWER  
    TOCOPHEROL  
    DMDM HYDANTOIN  
    HYDROGENATED SOYBEAN LECITHIN  
    PANTHENOL  
    EDETATE TRISODIUM  
    PEG-4 LAURATE  
    IODOPROPYNYL BUTYLCARBAMATE  
    MENTHYL LACTATE, (-)-  
    BENZYLIDENE DIMETHOXYDIMETHYLINDANONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-112-01 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 07/30/2012
    Part 2 of 6
    JAFRA PRO  EVEN TONE
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR GLYCERIN  
    INGR MEDIUM-CHAIN TRIGLYCERIDES  
    INGR ALKYL (C12-15) BENZOATE  
    INGR TETRAHEXYLDECYL ASCORBATE  
    INGR HEXYLRESORCINOL  
    INGR ETHYL LINOLEATE  
    INGR NIACINAMIDE  
    INGR PENTYLENE GLYCOL  
    INGR TITANIUM DIOXIDE  
    INGR STANNIC OXIDE  
    INGR SODIUM POLYACRYLATE (8000 MW)  
    INGR TRIDECETH-6  
    INGR CITRIC ACID MONOHYDRATE  
    INGR PAPAYA  
    INGR LICORICE  
    INGR COCONUT OIL  
    INGR CUCUMBER  
    INGR SANDALWOOD  
    INGR PASSIFLORA INCARNATA FLOWER  
    INGR APRICOT  
    INGR RASPBERRY  
    INGR CANANGA ODORATA FLOWER  
    INGR CANTALOUPE  
    INGR ALMOND  
    INGR SOYBEAN OIL  
    INGR ARNICA MONTANA FLOWER  
    INGR TOCOPHEROL  
    INGR DMDM HYDANTOIN  
    INGR PANTHENOL  
    INGR GLYCYRRHIZINATE DIPOTASSIUM  
    INGR EDETATE DISODIUM  
    INGR PEG-4 LAURATE  
    INGR IODOPROPYNYL BUTYLCARBAMATE  
    INGR BUTYLENE GLYCOL  
    INGR OAT  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 4 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 07/30/2012
    Part 3 of 6
    JAFRA PRO  NIGHT RECOVERY CONCENTRATE
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR GLYCERIN  
    INGR BUTYLENE GLYCOL  
    INGR PENTYLENE GLYCOL  
    INGR ABELMOSCHUS MOSCHATUS SEED  
    INGR XANTHAN GUM  
    INGR NIACINAMIDE  
    INGR HYALURONATE SODIUM  
    INGR TREHALOSE  
    INGR SODIUM PYRROLIDONE CARBOXYLATE  
    INGR UREA  
    INGR ALMOND  
    INGR XYLITOL  
    INGR CESTRUM LATIFOLIUM LEAF  
    INGR POLYSORBATE 20  
    INGR PALMITOYL OLIGOPEPTIDE  
    INGR PEG-8 DIMETHICONE  
    INGR PULLULAN  
    INGR PANTHENOL  
    INGR PAPAYA  
    INGR LICORICE  
    INGR CAPRYLYL GLYCOL  
    INGR COCONUT OIL  
    INGR CUCUMBER  
    INGR SANDALWOOD  
    INGR PASSIFLORA INCARNATA FRUIT  
    INGR APRICOT  
    INGR RASPBERRY  
    INGR CANTALOUPE  
    INGR SOYBEAN OIL  
    INGR ARNICA MONTANA FLOWER  
    INGR TOCOPHEROL  
    INGR METHYLISOTHIAZOLINONE  
    INGR OAT  
    INGR GLYCYRRHIZINATE DIPOTASSIUM  
    INGR EDETATE TRISODIUM  
    INGR LACTIC ACID  
    INGR ISOMALT  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 4 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 07/30/2012
    Part 4 of 6
    JAFRA PRO  DERMAL LINE FILLER
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR DIMETHICONE  
    INGR COPOVIDONE K25-31  
    INGR HYPROMELLOSES  
    INGR GLYCERIN  
    INGR SODIUM POLYACRYLATE (8000 MW)  
    INGR CYCLOMETHICONE 5  
    INGR TRIDECETH-6  
    INGR PEG/PPG-18/18 DIMETHICONE  
    INGR SILICON DIOXIDE  
    INGR PENTYLENE GLYCOL  
    INGR BUTYLENE GLYCOL  
    INGR POLYSORBATE 20  
    INGR PALMITOYL OLIGOPEPTIDE  
    INGR RYE  
    INGR MEDIUM-CHAIN TRIGLYCERIDES  
    INGR ACMELLA OLERACEA FLOWER  
    INGR HYALURONATE SODIUM  
    INGR TREHALOSE  
    INGR SODIUM PYRROLIDONE CARBOXYLATE  
    INGR ALMOND  
    INGR PAPAYA  
    INGR LICORICE  
    INGR ETHYLHEXYL PALMITATE  
    INGR DMDM HYDANTOIN  
    INGR CUCUMBER  
    INGR SANDALWOOD  
    INGR PASSIFLORA INCARNATA FRUIT  
    INGR APRICOT  
    INGR RASPBERRY  
    INGR CANANGA ODORATA FLOWER  
    INGR CANTALOUPE  
    INGR PANTHENOL  
    INGR NIACINAMIDE  
    INGR SOYBEAN OIL  
    INGR RASPBERRY  
    INGR ARNICA MONTANA FLOWER  
    INGR TOCOPHEROL  
    INGR EDETATE TRISODIUM  
    INGR IODOPROPYNYL BUTYLCARBAMATE  
    INGR OAT  
    INGR GLYCYRRHIZINATE DIPOTASSIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 4 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 07/30/2012
    Part 5 of 6
    JAFRA PRO  EYE TRANSFORMER
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR MEDIUM-CHAIN TRIGLYCERIDES  
    INGR SQUALANE  
    INGR POLYSORBATE 60  
    INGR BUTYLENE GLYCOL  
    INGR PANTHENOL  
    INGR ESCIN  
    INGR GLYCERIN  
    INGR RUSCUS ACULEATUS ROOT  
    INGR AMMONIUM GLYCYRRHIZATE  
    INGR CENTELLA ASIATICA  
    INGR CALENDULA OFFICINALIS FLOWER  
    INGR PENTYLENE GLYCOL  
    INGR ACMELLA OLERACEA FLOWER  
    INGR SACCHARIDE ISOMERATE  
    INGR POLYACRYLAMIDE (1500 MW)  
    INGR C13-14 ISOPARAFFIN  
    INGR LAURETH-7  
    INGR LAMINARIA OCHROLEUCA  
    INGR ALMOND  
    INGR STEARETH-20  
    INGR PALMITOYL TETRAPEPTIDE-7  
    INGR PALMITOYL OLIGOPEPTIDE  
    INGR CHRYSIN  
    INGR LAMINARIA HYPERBOREA  
    INGR SOYBEAN OIL  
    INGR ARNICA MONTANA FLOWER  
    INGR TOCOPHEROL  
    INGR TITANIUM DIOXIDE  
    INGR STANNIC OXIDE  
    INGR GLYCYRRHIZINATE DIPOTASSIUM  
    INGR ALLANTOIN  
    INGR ALPHA-TOCOPHEROL ACETATE  
    INGR COCONUT OIL  
    INGR CUCUMBER  
    INGR SANDALWOOD  
    INGR PASSIFLORA INCARNATA FRUIT  
    INGR apricot  
    INGR RASPBERRY  
    INGR CANTALOUPE  
    INGR CANANGA ODORATA FLOWER  
    INGR PEG-4 LAURATE  
    INGR IODOPROPYNYL BUTYLCARBAMATE  
    INGR OAT  
    INGR PAPAYA  
    INGR LICORICE  
    INGR EDETATE TRISODIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 4 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 07/30/2012
    Part 6 of 6
    JAFRA PRO  EYE TRANSFORMER
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR MEDIUM-CHAIN TRIGLYCERIDES  
    INGR SQUALANE  
    INGR POLYSORBATE 60  
    INGR BUTYLENE GLYCOL  
    INGR PANTHENOL  
    INGR ESCIN  
    INGR GLYCERIN  
    INGR RUSCUS ACULEATUS ROOT  
    INGR AMMONIUM GLYCYRRHIZATE  
    INGR CENTELLA ASIATICA  
    INGR CALENDULA OFFICINALIS FLOWER  
    INGR PENTYLENE GLYCOL  
    INGR ACMELLA OLERACEA FLOWER  
    INGR SACCHARIDE ISOMERATE  
    INGR C13-14 ISOPARAFFIN  
    INGR LAURETH-7  
    INGR ALMOND  
    INGR STEARETH-20  
    INGR CHRYSIN  
    INGR N-HYDROXYSUCCINIMIDE  
    INGR LAMINARIA HYPERBOREA  
    INGR POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)  
    INGR SOYBEAN OIL  
    INGR ARNICA MONTANA FLOWER  
    INGR TOCOPHEROL  
    INGR TITANIUM DIOXIDE  
    INGR STANNIC OXIDE  
    INGR DMDM HYDANTOIN  
    INGR DISODIUM GLYCYRRHIZATE  
    INGR ALLANTOIN  
    INGR ALPHA-TOCOPHEROL ACETATE  
    INGR COCONUT OIL  
    INGR CUCUMBER  
    INGR SANDALWOOD  
    INGR PASSIFLORA INCARNATA FRUIT  
    INGR APRICOT  
    INGR RASPBERRY  
    INGR CANANGA ODORATA FLOWER  
    INGR CANTALOUPE  
    INGR PEG-4 LAURATE  
    INGR IODOPROPYNYL BUTYLCARBAMATE  
    INGR OAT  
    INGR PAPAYA  
    INGR LICORICE  
    INGR EDETATE TRISODIUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 4 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 07/30/2012
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 07/30/2012
    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(68828-111, 68828-112)
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