Label: PARROT HEAD DEDICATED TO SUNSHINE OIL 4- octinoxate, octisalate spray

  • 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 May 15, 2012

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

  • Active Ingredients

    Octinoxate 4.5%
    Octisalate 5.0%
  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging.  This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    For external use only.  Do not use on damaged or broken skin.  Stop use and ask a doctor if rash occurs.  When using this product keep out of eyes.  Rinse with water to remove.  Keep out of the reach of children.  If swallowed, get medical help or call a poison control center right away.

  • Directions

    • apply evenly and liberally to all exposed areas 15 minutes before sun exposure.  Ensure skin is completely covered with product.
    • reapply after 40 minutes of swimming or sweating, immediately after towel drying and at least every 2 hours
    • children under 6 months:  Ask a doctor
  • Other Information

    • protect this product from excessive heat and direct sun
    • for use on skin only
    • avoid contact with fabric
  • PRINCIPAL DISPLAY PANEL

    image of carton label

  • INGREDIENTS AND APPEARANCE
    PARROT HEAD DEDICATED TO SUNSHINE OIL 4 
    octinoxate, octisalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62802-114
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.5 mL  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CARROT (UNII: L56Z1JK48B)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAURETH-4 (UNII: 6HQ855798J)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    BORAGE OIL (UNII: F8XAG1755S)  
    BRAZIL NUT OIL (UNII: 0G89T29HO6)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62802-114-85251 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2012
    Labeler - Sun & Skin Care Research, LLC (849772207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun & Skin Care Research, LLC849772207manufacture