Label: ELAVE AGE DELAY DAILY LIP DEFENCE SPF20- octinoxate, zinc oxide ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 December 13, 2011

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  • ACTIVE INGREDIENT

    DRUG FACTS


    ACTIVE INGREDIENTS                               PURPOSE

    Octinoxate 7.5%w/w                                   Sunscreen

    Zinc Oxide 4.0%w/w                                   Sunscreen
  • PURPOSE

    USES

    • helps protect against sunburn
    • for lips that sunburn easily
    • helps provide protection against UVA and UVB rays
  • WARNINGS

    WARNINGS

    For external use only

    Do not use on

    • broken skin
    • serious burns
    When using this product

    • keep out of the eyes. Rinse with water to remove
    • not suitable for ingestion
    Stop use and ask a doctor if

    • rash or irritation develops and lasts
    Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away
  • WHEN USING

    DIRECTIONS


    • apply to lips 15 - 20 minutes before sun exposure
    • re-apply as needed, especially after prolonged sun exposure, drinking or eating
  • OTHER SAFETY INFORMATION

    OTHER INFORMATION

    • store below 25C, do not freeze
    • not recommended for children under 6 months of age
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS


    Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Cera Alba (Beeswax), Oryza Sativa (Rice) Bran Wax, Butyrospermum Parkii (Shea Butter), Stearyl Dimethicone, Copernicia Cerifera (Carnauba) Wax, Dipalmitoyl Hydroxyproline, Phenyl Trimethicone, Bixa Orellana Seed Oil, Mentha Piperita (Peppermint Oil), Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Cocos Nucifera (Coconut) Oil, BHT, Triethoxycaprylylsilane
  • QUESTIONS

    QUESTIONS OR COMMENTS

    Distributor: Ashette LLC, 27-28 Thomson Ave, Long Island City NY11101

    www.ashette.com

    Manufacturer: Ovelle Pharmaceuticals, Coes Road, Dundalk, Co Louth, Ireland
  • PRINCIPAL DISPLAY PANEL

    age delay daily lip defence

    SPF20

    Sensitive Formula

    Broad-Spectrum UVA/UVB Protection

    Preservative Fee

    Anti-oxidant Vitamin E

    Soothing Aloe Vera Leaf Extract

    Triple Firming Natural Lipoamino Acid

    Refreshing Peppermint Oil

    FREE FROM

    Parabens, Alcohol, Sulfates, SLES/SLS, Formaldehyde, Dyes, Colours, Phthalates, Lanolin, Fragrance
  • PRINCIPAL DISPLAY PANEL





    4600600201

    4600600201



  • INGREDIENTS AND APPEARANCE
    ELAVE AGE DELAY DAILY LIP DEFENCE  SPF20
    octinoxate, zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46006-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate1.125 mL  in 15 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.6 mL  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    Castor Oil (UNII: D5340Y2I9G)  
    Hydrogenated Castor Oil (UNII: ZF94AP8MEY)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Rice Bran (UNII: R60QEP13IC)  
    Shea Butter (UNII: K49155WL9Y)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Carnauba Wax (UNII: R12CBM0EIZ)  
    Dipalmitoyl Hydroxyproline (UNII: E6AHA53N1H)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Bixa Orellana Seed Oil (UNII: 3R3HS2KR6P)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Coconut Oil (UNII: Q9L0O73W7L)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46006-002-0115 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35212/20/2011
    Labeler - Ovelle Ltd (219542784)
    Registrant - Ovelle Ltd (219542784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ovelle Ltd219542784manufacture
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