Label: CORTEX SUNX 50 THICK- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 65753-602-22, 65753-602-23, 65753-602-24, 65753-602-26, view more
    65753-602-31
  • Packager: CoreTex Products Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 6, 2023

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

View All Sections
  • 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 and 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 barbedensis 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?

    Call: 1-877-684-5774

  • 65753-602-24

    602-24

  • 65753-602-22,-23,-26,and -31

    602

  • INGREDIENTS AND APPEARANCE
    CORTEX SUNX 50 THICK 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65753-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    WATER (UNII: 059QF0KO0R)  
    THEOBROMA CACAO WHOLE (UNII: EB048G1S9J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    C12-20 ALKYL BENZOATE (UNII: Y15I6XI14C)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65753-602-2225 in 1 CONTAINER03/09/2023
    17 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:65753-602-2325 in 1 CONTAINER03/09/2023
    27 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:65753-602-2450 in 1 CONTAINER03/09/2023
    37 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:65753-602-26150 in 1 CARTON03/09/2023
    47 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:65753-602-31300 in 1 CARTON03/09/2023
    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 DrugM02003/09/2023
    Labeler - CoreTex Products Inc (061944620)
    Establishment
    NameAddressID/FEIBusiness Operations
    CoreTex Products Inc061944620pack(65753-602)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prime Enterprises101946028manufacture(65753-602)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!