Label: CORETEX SUN X SPF 30 MULTIPACK NEW- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 65753-109-22, 65753-109-23, 65753-109-24, 65753-109-26, view more
    65753-109-31
  • Packager: CoreTex Products
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 22, 2023

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  • Active ingredients

    Avobenzone 3%

    Homosalate 7.5%

    Octisalate 5%

    Octocrylene 5%

  • Purpose

    Sunscreen

    Sunscreen

    Sunscreen

    Sunscreen

  • Uses

    • helps prevent sunburn.
    • higher SPF gives more sunburn protection.
    • 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 product is 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 and 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, ethylhexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan oleate, theobroma cacao (cocoa) seed butter, tocopheryl acetate, water

  • Questions and comments?

    Call: 1-877-684-5774

  • Kit Contents

    1-Towelette

  • 65753-109-22-23-31-26

    sunxpouch

  • 65753-109-24

    109-24

  • INGREDIENTS AND APPEARANCE
    CORETEX SUN X SPF 30 MULTIPACK NEW 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    PROPYLENE GLYCOL PROPYL ETHER (UNII: 92KA3PYX0S)  
    MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-109-2225 in 1 CONTAINER01/08/2023
    17 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:65753-109-2325 in 1 CONTAINER01/08/2023
    27 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:65753-109-2450 in 1 CONTAINER01/08/2023
    37 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:65753-109-31150 in 1 BOX01/08/2023
    47 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:65753-109-26300 in 1 BOX01/08/2023
    57 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/08/2023
    Labeler - CoreTex Products (061944620)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoreTex Products061944620manufacture(65753-109)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises101946028manufacture(65753-109)
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