Label: CORETEX SUN X SPF 30 THIN- avobenzone, homosalate, octinoxate, octisalate, oxybenzone liquid

  • NDC Code(s): 65753-101-11, 65753-101-12, 65753-101-22, 65753-101-23, view more
    65753-101-24, 65753-101-25, 65753-101-26, 65753-101-27
  • Packager: CoreTex Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

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 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 eye. 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 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 (aloe vera) leaf juice, butylparaben, calendula officinalis flower extract, carbomer, chamomile recutita (matricaria) extract, C12-15 alkyl benzoate, dimethicone, dimethyl capramide, ethylparaben, fragrance (parfum), glyceryl stearate, isobutylparaben, methylparaben, nasturtium officinale (watercress) extract, peg-100 stearate, phenoxyethanol, propylparaben, symphytum officinale (comfrey) leaf extract, tetrasodium EDTA, tocopherol, tocopheryl acetate, triethanolamine, water

  • Questions and comments?

    Call: 1-877-684-5774

  • Principal Display Panel 101-12

    101

  • 101-11

    101-11

  • INGREDIENTS AND APPEARANCE
    CORETEX SUN X SPF 30 THIN 
    avobenzone, homosalate, octinoxate, octisalate, oxybenzone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 g  in 100 mL
    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
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    NASTURTIUM OFFICINALE (UNII: YH89GMV676)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TETRASODIUM EDETATE DIHYDRATE (UNII: 3JGX4KKZ4A)  
    FRAGRANCE 13576 (UNII: 5EM498GW35)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-101-1159 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/22/2019
    2NDC:65753-101-12118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/22/2019
    3NDC:65753-101-2716 in 1 BOX11/22/201811/21/2022
    37 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:65753-101-2225 in 1 CONTAINER11/22/201911/21/2022
    47 mL in 1 PACKET; Type 0: Not a Combination Product
    5NDC:65753-101-2350 in 1 CONTAINER11/22/201911/21/2022
    57 mL in 1 PACKET; Type 0: Not a Combination Product
    6NDC:65753-101-2450 in 1 CARTON11/22/201911/21/2022
    67 mL in 1 PACKET; Type 0: Not a Combination Product
    7NDC:65753-101-25100 in 1 CARTON11/22/201911/21/2022
    77 mL in 1 PACKET; Type 0: Not a Combination Product
    8NDC:65753-101-26300 in 1 BOX11/22/201911/21/2022
    87 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/22/2018
    Labeler - CoreTex Products Inc (061944620)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoreTex Products Inc061944620pack(65753-101)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source080354456manufacture(65753-101)
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