Label: SUNSECT INSECT REPELLENT SUNSCREEN- octinoxate, oxybenzone, octisalate lotion

  • NDC Code(s): 57595-001-01, 57595-001-02, 57595-001-03, 57595-001-04
  • Packager: Iguana LLC
  • 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 June 20, 2015

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

  • Active Ingredients

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

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  • Purpose

    Sunscreen

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  • Uses

    • helps prevent sunburn
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  • 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.

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  • 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
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  • Other Information

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

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  • Comments/Questions?

    1-229-228-0980

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  • Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    SUNSECT INSECT REPELLENT SUNSCREEN 
    octinoxate, oxybenzone, octisalate lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:57595-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 g  in 100 g
    DIETHYLTOLUAMIDE (UNII: FB0C1XZV4Y) (DIETHYLTOLUAMIDE - UNII:FB0C1XZV4Y) DIETHYLTOLUAMIDE 20 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57595-001-01 59 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2015
    2 NDC:57595-001-02 118 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/01/2015
    3 NDC:57595-001-03 3672 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 06/01/2015
    4 NDC:57595-001-04 50 in 1 BOX 06/01/2015
    4 9 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 06/01/2015
    Labeler - Iguana LLC (109358551)
    Establishment
    Name Address ID/FEI Business Operations
    Solo Laboratories, Inc. 005126784 manufacture(57595-001) , pack(57595-001) , label(57595-001)
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