Label: SUNX SPF 30/BUGX WALLMOUNT kit

  • NDC Code(s): 65753-101-10, 65753-511-24
  • Packager: CoreTex Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 22, 2023

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  • Active ingredients

    Avobenzone 1.0%

    Homosalate 5.0%

    Octinoxate 7.5%

    Octisalate 5.0%

    Oxybenzone 6.0%

  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

  • Uses

    • helps prevent sunburn
    • higher SPF gives more sunburn protetion.
    • retains SPF after 80 minutes of activity in the water or sweating
    • provides high protection against sunburn.
  • Warnings

    For external use only.

    Do not use

    • on damaged or broken skin

    When using this product

    • keep out of the eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash or irritation develops and lasts

    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
    • Reapply:
    • after 80 minutes of swimming or sweating
    • after towel drying, swimming , or
      • at least every 2 hours
    • children under 6 months of age: Ask a doctor
  • Other information

    • Protect this product from excessive heat or direct sun

    Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin aging, skin cancer, and other harmful effects of the sun.

  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis leaf juice, C12-15 alkyl benzoate, carbomer, disodium EDTA, ethylexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, soritan oleate, theobroma cacao (cocoa) seed butter, tocopherol, tocopheryl acetate, water

  • Questions?

    Call: 1-877-684-5774

  • SunX/BugX Kit Contents

    50 count- SunX SPF 30, BugX 30

  • Principal Display Panel

    suns-bugxfr

  • SunX SPF 30 label

    sunxlotion pouch

  • INGREDIENTS AND APPEARANCE
    SUNX SPF 30/BUGX WALLMOUNT 
    sunx spf 30/bugx wallmount kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-511
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-511-241 in 1 KIT; Type 0: Not a Combination Product10/11/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 150 POUCH 350 mL
    Part 1 of 1
    CORETEX SUN X SPF 30 THIN 
    avobenzone, homosalate, octinoxate, octisalate, oxybenzone liquid
    Product Information
    Item Code (Source)NDC:65753-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL 1-CAPRYLATE (UNII: TL885HYH94)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-101-107 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02010/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/11/2023
    Labeler - CoreTex Products Inc (061944620)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoreTex Products Inc061944620pack(65753-101, 65753-511)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source080354456manufacture(65753-101)
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