EB5 ULTRA LIGHT FACE SPF 15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [ELEMENTS BRANDS, INC]

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EB5 ULTRA LIGHT FACE SPF 15 (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [ELEMENTS BRANDS, INC]
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NDC 71221-325-00
Set ID 86b2b866-0cd2-4cfd-87e7-483e0e5742f8
Category HUMAN OTC DRUG LABEL
Packager Elements Brands, Inc
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active ingredients

    Octinoxate 5%

    Octisalate 3%

    Zinc Oxide 3%

    Purpose

    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.
  • 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.

    Stop use and consult physician

    if irritation or rash develops.

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Directions

    • Apply liberally 15-minutes before sun exposure.
    • Reapply:

    -At least every two-hours.

    -Immediately after swimming, sweating or towel drying.

    SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and ealy skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

    -Limit time in the sun, especially between 10am and 2pm.

    -Wear long sleeve shirts, pants, hats and sunglasses.

    -For children under 6-months, consult a physician.

  • Other information

    • Protect the product in this container from excessive heat and direct sunlight.
  • Other ingredients

    Allantoin, Aqua (Deionized Water), Avena Sativa (Oat) Kernel Protein, Carbomer, Cetyl Alcohol, Dimethicone, dl-Panthenol, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorbate-20, Potassium Sorbate, Propylene Glycol, Retinyl Palmitate (Vitamin A), Silica, Sodium Hydroxide, Stearic Acid, Tocopheryl Acetate (Vitamin E)

  • Question or Comments?

    1-800-683-2325 or help@eb5.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    EB5 ULTRA LIGHT FACE SPF 15 
    octinoxate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71221-325
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    WATER (UNII: 059QF0KO0R)  
    OAT (UNII: Z6J799EAJK)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71221-325-001 in 1 BOX05/01/2018
    170.8 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35205/01/2018
    Labeler - Elements Brands, Inc (006166707)
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