SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]

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  • SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]

SUNSECT INSECT REPELLENT SUNSCREEN (OCTINOXATE, OXYBENZONE, OCTISALATE) LOTION [IGUANA LLC]
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NDC 57595-001-01, 57595-001-02, 57595-001-03, 57595-001-04
Set ID 6ccdc093-8af9-4bd8-84b0-f229fccd2f1c
Category HUMAN OTC DRUG LABEL
Packager Iguana LLC
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredients

    Octinoxate: 7.5%
    Oxybenzone: 6%
    Octisalate: 5%

  • 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 help prevent sunbrun, not skin cancer or early skin aging.

    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 ask a doctor if rash occurs. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • children under 6 months of age: Ask a doctor
    • reapply: after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
  • Other Information

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

    acrylates/C10-30 alkyl acrylate copolymer, carrageenan, carboxy vinyl polymer, cetostearyl alcohol, diazolidinyl urea, diethanolamine cetyl phosphate, methylparaben, propylparaben, propylene glycol, tocopheryl acetate (Vitamin E), tricontanyl povidone, water

  • Comments/Questions?

    1-229-228-0980

  • Principal Display Panel

    image of 0.3 oz packet label

    image of 4 oz back panel label

    image of 4 oz front panel label

    image of 2 oz back panel label

    image of 2 oz front panel labelimage of 1-gallon labelimage of 50-count carton label

  • INGREDIENTS AND APPEARANCE
    SUNSECT INSECT REPELLENT SUNSCREEN 
    octinoxate, oxybenzone, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57595-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 g
    DIETHYLTOLUAMIDE (UNII: FB0C1XZV4Y) (DIETHYLTOLUAMIDE - UNII:FB0C1XZV4Y) DIETHYLTOLUAMIDE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)  
    TRICONTANYL POVIDONE (UNII: N0SS3Q238D)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CITRONELLA OIL (UNII: QYO8Q067D0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57595-001-0159 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
    2NDC:57595-001-02118 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2015
    3NDC:57595-001-033672 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2015
    4NDC:57595-001-0450 in 1 BOX06/01/2015
    49 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2015
    Labeler - Iguana LLC (109358551)
    Establishment
    NameAddressID/FEIBusiness Operations
    Solo Laboratories, Inc.005126784manufacture(57595-001) , pack(57595-001) , label(57595-001)
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