Label: CORETEX SUN X 50- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 65753-603-01, 65753-603-02, 65753-603-03, 65753-603-04, view more
    65753-603-05, 65753-603-07, 65753-603-09, 65753-603-10, 65753-603-22, 65753-603-23, 65753-603-24, 65753-603-25, 65753-603-26, 65753-603-32, 65753-603-33, 65753-603-34, 65753-603-39
  • Packager: CoreTex Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 20, 2023

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  • Active ingredients

    Avobenzone...3%

    Homosalate...10%

    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 eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    • rash or irritation develops or lasts

    Keep out of 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 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, ethylexylglycerin, hydroxypropyl methylcellulose phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, sorbitan oleate, theobroma cacao (cocoa) seed butter, tocopheryl acetate, water

  • Questions?

    Call 1-877-684-5774

  • -603-34

    600-34

  • -603-01

    600-01

  • -603-02

    600-02

  • -603-03

    600-03

  • -603-04

    600-04

  • -603-05

    600-05

  • -603-07

    600-07

  • -603-09

    600-09

  • -603-10

    600-10

  • -603-22-23-26-39

    600-22-23-26-39

  • -603-24

    600-24

  • -603-25

    600-25

  • -603-32

    600-32

  • -603-33

    600-33

  • -603-35

    600-35

  • INGREDIENTS AND APPEARANCE
    CORETEX SUN X 50 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-603-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    2NDC:65753-603-3244 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    3NDC:65753-603-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    4NDC:65753-603-3360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    5NDC:65753-603-03118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    6NDC:65753-603-34118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    7NDC:65753-603-04177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    8NDC:65753-603-05237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    9NDC:65753-603-07473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    10NDC:65753-603-09946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    11NDC:65753-603-103788 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/03/2023
    12NDC:65753-603-397 mL in 1 POUCH; Type 0: Not a Combination Product01/03/2023
    13NDC:65753-603-2225 in 1 CONTAINER01/03/2023
    13NDC:65753-603-397 mL in 1 POUCH; Type 0: Not a Combination Product
    14NDC:65753-603-2325 in 1 CONTAINER01/03/2023
    14NDC:65753-603-397 mL in 1 POUCH; Type 0: Not a Combination Product
    15NDC:65753-603-2450 in 1 CONTAINER01/03/2023
    15NDC:65753-603-397 mL in 1 POUCH; Type 0: Not a Combination Product
    16NDC:65753-603-25100 in 1 CONTAINER01/03/2023
    16NDC:65753-603-397 mL in 1 POUCH; Type 0: Not a Combination Product
    17NDC:65753-603-26300 in 1 CARTON01/03/2023
    17NDC:65753-603-397 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/03/2023
    Labeler - CoreTex Products Inc (061944620)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoreTex Products Inc061944620pack(65753-603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises101946028manufacture(65753-603)
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