Label: NOURIFUSION - avobenzone, octinoxate and octisalate lotion 

  • NDC Code(s): 51785-514-01
  • Packager: Herbalife International of America 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 06/13

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

  • Active Ingredients

    Avobenzone (2%)

    Octinoxate (7%)

    Octisalate (3%)

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  • Purpose

    Sunscreen

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  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measure(see Directions), may decrease the risk of skin cancer and early skin aging caused by the sun
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  • Warnings

    For external use only

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  • DO NOT USE

    Do not use on damaged or broken skin

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  • STOP USE

    Stop use and ask a doctor if rash occurs

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  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • 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
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  • Other information

    • Protect the product in this container from excessive heat and direct sun.
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  • Inactive ingredients

    Water (Aqua), Dimethicone, C12-15 Alkyl Benzoate, Cetyl Phosphate, Cetearyl Alcohol, Panthenol, Tocopheryl Acetate, Tocopherol, Sodium Ascorbate, Retinol, Trifolium Pratense (Clover) Leaf Extract, Calendula Officinalis Flower Extract, Hydrolyzed Enteromorpha Compressa, Yeast Extract, Helianthus Annuus (Sunflower) Seed Oil, Triticum Vulgare (Wheat) Germ Oil, Persea Gratisima (Avocado) Oil, Prunus Armeniaca (Apricot) Kernel Oil, Olea Europaea (Olive) Fruit Oil, Wheat Germ Glycerides, Butylene Glycol, Glycerin, Dipropylene Glycol Dibenzoate, Caprylic/Capric Triglyceride, PPG-15 Stearyl Ether Benzoate, Ceteareth-20, Polyacrylamide, C13-14 Isoparaffin, Laureth-7, Carbomer, Aminomethyl Propanol, Disodium EDTA, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben, Butylparaben, Isobutylparaben, Red 33 (CI 17200).

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  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Hearbalife International of America, Inc.

    800 W. Olympic Blvd. Suite 406

    Los Angeles, CA 90015, USA

    Herbalife Internation Luxembourg S.a R.L.

    L-1610 Luxenbourg

    Imported and Distributed in Canada by:

    Herbalife of Canada Ltd.

    Importe et distribue au Canada par:

    Herbalife du Canada Ltee

    Calgary, Alberta, Canada T2B 3P1

    Made in USA with US and imported ingredients

    Fabrique aux Etats-Unis avec des ingredients

    americains et importes

    2012 Herbalife

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  • Principal Display Panel

    HERBALIFE

    NouriFusion

    sunscreen

    broad spectrum SPF 15

    moisturizing lotion

    with conditioning antioxidant

    vitamins A, C and E

    normal to dry

    normale a seche

    ecran solaire

    large spectre FPS 15

    lotion hydratante

    avec vitamines

    antioxydantes

    revitalisantes A, C et E

    DIN No. 02259192

    Box Label

    Container Label


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  • INGREDIENTS AND APPEARANCE
    NOURIFUSION 
    avobenzone, octinoxate, octisalate lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51785-514
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (AVOBENZONE) AVOBENZONE 1.079 g  in 50 mL
    OCTINOXATE (OCTINOXATE) OCTINOXATE 3.535 g  in 50 mL
    OCTISALATE (OCTISALATE) OCTISALATE 1.52 g  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    DIMETHICONE  
    ALKYL (C12-15) BENZOATE  
    CETYL PHOSPHATE  
    CETOSTEARYL ALCOHOL  
    PANTHENOL  
    .ALPHA.-TOCOPHEROL ACETATE  
    TOCOPHEROL  
    SODIUM ASCORBATE  
    RETINOL  
    TRIFOLIUM PRATENSE LEAF  
    CALENDULA OFFICINALIS FLOWER  
    ULVA COMPRESSA PROTEIN (ACID HYDROLYZED, 300-5000 MW)  
    YEAST  
    SUNFLOWER OIL  
    WHEAT GERM OIL  
    AVOCADO OIL  
    APRICOT KERNEL OIL  
    OLIVE OIL  
    D&C RED NO. 33  
    1,3-BUTYLENE GLYCOL  
    GLYCERIN  
    DIPROPYLENE GLYCOL DIBENZOATE  
    MEDIUM-CHAIN TRIGLYCERIDES  
    PPG-15 STEARYL ETHER BENZOATE  
    POLYOXYL 20 CETOSTEARYL ETHER  
    POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE)  
    C13-14 ISOPARAFFIN  
    LAURETH-7  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)  
    AMINOMETHYLPROPANOL  
    EDETATE DISODIUM  
    PHENOXYETHANOL  
    METHYLPARABEN  
    ETHYLPARABEN  
    PROPYLPARABEN  
    BUTYLPARABEN  
    ISOBUTYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51785-514-01 50 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 09/25/2012
    Labeler - Herbalife International of America Inc. (873035968)
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