Label: TEA BLEND SAMPLES JAFRA- avobenzone, octinoxate, octisalate

  • NDC Code(s): 68828-119-01, 68828-120-01
  • Packager: JAFRA COSMETICS INTERNATIONAL
  • 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 01/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients purpose

    Avobenzone 2.5% Sunscreen

    Octinoxate 7.5% Sunscreen

    Octisalate 5% 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 swallowed, get medical help or contact a Poison Control Center.

    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

    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, Polyglyceryl-3 Methylglucose Distearate, polyacrylamide, C13-14 Isoparaffin, Laureth-7, Glycerin, Glyceryl Stearate, Saccharide Isomerate, Fragrance/Parfum, Carica Papaya Extract, Glycyrrhiza Glabra (Licorice) Extract, Panthenol, Tocopheryl Acetate. Camellia Sinensis Leaf Extract, Trisodium EDTA, Ethylhexylglycerin, Methylisothiazolinone.

    Close
  • PRINCIPAL DISPLAY PANEL

    carton back

    carton front

    Tea Blend

    Tester

    Contains: 3 samples

    1 Daily Moisturizer Broad Spectrum SPF 15/1 Nightly Moisturizer/ 1 Cleanser + Toner

    Cont. Net. 22,5 ml .76 Fl Oz (US)

    Close
  • INGREDIENTS AND APPEARANCE
    TEA BLEND SAMPLES  JAFRA
    avobenzone, octinoxate, octisalate kit
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:68828-119
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-119-01 1 in 1 KIT
    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 1 of 3
    DAILY MOISTURIZER BROAD SPECTRUM SPF 15  JAFRA
    avobenzone, octinoxate, octisalate cream
    Product Information
    Item Code (Source) NDC:68828-120
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 2.5 g  in 100 mL
    OCTINOXATE (OCTINOXATE) OCTINOXATE 7.5 g  in 100 mL
    OCTISALATE (OCTISALATE) OCTISALATE 5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POLYACRYLAMIDE (1500 MW)  
    C13-14 ISOPARAFFIN  
    LAURETH-7  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    SACCHARIDE ISOMERATE  
    LICORICE  
    PANTHENOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    GREEN TEA LEAF  
    EDETATE TRISODIUM  
    ETHYLHEXYLGLYCERIN  
    METHYLISOTHIAZOLINONE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68828-120-01 7.5 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 01/18/2013
    Part 2 of 3
    CLEANSER AND TONER  JAFRA
    body and hand (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR SODIUM COCOYL GLYCINATE  
    INGR SODIUM LAUROYL OAT AMINO ACIDS  
    INGR SODIUM C14-16 OLEFIN SULFONATE  
    INGR COCAMIDOPROPYL BETAINE  
    INGR PEG-150 PENTAERYTHRITYL TETRASTEARATE  
    INGR PEG-8 DIMETHICONE  
    INGR SACCHARIDE ISOMERATE  
    INGR DMDM HYDANTOIN  
    INGR IODOPROPYNYL BUTYLCARBAMATE  
    INGR ALLANTOIN  
    INGR CITRIC ACID MONOHYDRATE  
    INGR GREEN TEA LEAF  
    INGR PAPAYA  
    INGR LICORICE  
    INGR EDETATE SODIUM  
    INGR PANTHENOL  
    INGR PROPYLENE GLYCOL  
    INGR HAMAMELIS VIRGINIANA TOP  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 7.5 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 01/18/2013
    Part 3 of 3
    NIGHTLY MOISTURIZER  JAFRA
    face and neck (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR C10-18 TRIGLYCERIDES  
    INGR MEDIUM-CHAIN TRIGLYCERIDES  
    INGR GLYCERIN  
    INGR CETYL ALCOHOL  
    INGR SHEA BUTTER  
    INGR GLYCERYL MONOSTEARATE  
    INGR CETOSTEARYL ALCOHOL  
    INGR SODIUM STEAROYL LACTYLATE  
    INGR CELLULOSE, MICROCRYSTALLINE  
    INGR CARBOXYMETHYLCELLULOSE SODIUM  
    INGR SACCHARIDE ISOMERATE  
    INGR PAPAYA  
    INGR LICORICE  
    INGR DMDM HYDANTOIN  
    INGR VERBENA OFFICINALIS  
    INGR XANTHAN GUM  
    INGR PANTHENOL  
    INGR .ALPHA.-TOCOPHEROL ACETATE  
    INGR GREEN TEA LEAF  
    INGR EDETATE TRISODIUM  
    INGR PEG-4 LAURATE  
    INGR IODOPROPYNYL BUTYLCARBAMATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 7.5 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Cosmetic 01/21/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 01/18/2013
    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(68828-119, 68828-120)
    Close