FDA.reportPublic FDA data

CoreTex SunX 50 Thick

Manufacturer
CoreTex Products Inc | Prime Enterprises
Effective date
2026-04-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:53:28

Label at a glance#

ProductCorTex SunX 50 Thick
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure24 sections

Indications and 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.

Dosage and administration

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.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Avobenzone...3%

Homosalate...10%

Octisalate...5%

Octocrylene...5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation develops and lasts

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • 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:

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call: 1-877-684-5774

65753-603-09

SPL PATIENT PACKAGE INSERT SECTION

604-09604-09

65753-602-24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

602-24602-24

65753-602-22,-23,-26,and -31

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

602602

65753-603-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-03604-03

65753-603-22,-23,-24,-25,-26

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

603-22603-22

65753-603-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-10604-10

65753-603-35

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-35604-35

65753-603-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-02604-02

65753-603-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-01604-01

65753-603-33

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-33604-33

65753-603-07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-07604-07

65753-603-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-05604-05

65753-603-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-04604-04

65753-603-34

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-34604-34

65753-603-32

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

604-32604-32

65753-603-39

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

603-39603-39

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130698129614330GTIN-13: 0698129614330
EAN-13: 0698129614330
GTIN-12: 698129614330
UPC-A: 698129614330
GTIN storage (14 digits): 00698129614330		603-39.jpg
BarcodeEAN-130698229614339GTIN-13: 0698229614339
EAN-13: 0698229614339
GTIN-12: 698229614339
UPC-A: 698229614339
GTIN storage (14 digits): 00698229614339		603-39.jpg, sunx50-Pouch-Towelette_rev1222.jpg
BarcodeEAN-130698229616616GTIN-13: 0698229616616
EAN-13: 0698229616616
GTIN-12: 698229616616
UPC-A: 698229616616
GTIN storage (14 digits): 00698229616616		602-24.jpg
BarcodeEAN-130698229616623GTIN-13: 0698229616623
EAN-13: 0698229616623
GTIN-12: 698229616623
UPC-A: 698229616623
GTIN storage (14 digits): 00698229616623		603.02.jpg
BarcodeEAN-130698229616647GTIN-13: 0698229616647
EAN-13: 0698229616647
GTIN-12: 698229616647
UPC-A: 698229616647
GTIN storage (14 digits): 00698229616647		603-34.jpg
BarcodeEAN-130698229616678GTIN-13: 0698229616678
EAN-13: 0698229616678
GTIN-12: 698229616678
UPC-A: 698229616678
GTIN storage (14 digits): 00698229616678		603.33.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-602-22CorTex SunX 50 Thick25 in 1 CONTAINERLOTION256
65753-602-22CorTex SunX 50 Thick7 g in 1 POUCHLOTION76
65753-602-23CorTex SunX 50 Thick25 in 1 CONTAINERLOTION256
65753-602-23CorTex SunX 50 Thick7 g in 1 POUCHLOTION76
65753-602-24CorTex SunX 50 Thick7 g in 1 POUCHLOTION76
65753-602-24CorTex SunX 50 Thick50 in 1 CONTAINERLOTION506
65753-602-26CorTex SunX 50 Thick7 g in 1 POUCHLOTION76
65753-602-26CorTex SunX 50 Thick150 in 1 CARTONLOTION1506
65753-602-31CorTex SunX 50 Thick300 in 1 CARTONLOTION3006
65753-602-31CorTex SunX 50 Thick7 g in 1 POUCHLOTION76
65753-603-01CorTex SunX 50 Thick30 mL in 1 BOTTLELOTION306
65753-603-02CorTex SunX 50 Thick60 mL in 1 BOTTLELOTION606
65753-603-03CorTex SunX 50 Thick120 mL in 1 BOTTLELOTION1206
65753-603-04CorTex SunX 50 Thick177 mL in 1 BOTTLELOTION1776
65753-603-05CorTex SunX 50 Thick237 mL in 1 BOTTLELOTION2376
65753-603-07CorTex SunX 50 Thick473 mL in 1 BOTTLELOTION4736
65753-603-08CorTex SunX 50 Thick762 mL in 1 BOTTLE, DISPENSINGLOTION7626
65753-603-09CorTex SunX 50 Thick960 mL in 1 BOTTLELOTION9606
65753-603-10CorTex SunX 50 Thick3800 mL in 1 BOTTLELOTION38006
65753-603-22CorTex SunX 50 Thick25 in 1 CONTAINERLOTION256
65753-603-23CorTex SunX 50 Thick25 in 1 CONTAINERLOTION256
65753-603-24CorTex SunX 50 Thick50 in 1 CONTAINERLOTION506
65753-603-25CorTex SunX 50 Thick100 in 1 CONTAINERLOTION1006
65753-603-26CorTex SunX 50 Thick150 in 1 CARTONLOTION1506
65753-603-32CorTex SunX 50 Thick44 mL in 1 BOTTLELOTION446
65753-603-33CorTex SunX 50 Thick60 mL in 1 BOTTLELOTION606
65753-603-34CorTex SunX 50 Thick120 mL in 1 BOTTLELOTION1206
65753-603-35CorTex SunX 50 Thick762 mL in 1 BOTTLELOTION7626
65753-603-39CorTex SunX 50 Thick7 mL in 1 POUCHLOTION76

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65753-60265753-602-22, 65753-602-23, 65753-602-24, 65753-602-26, 65753-602-31
65753-60365753-603-39, 65753-603-22, 65753-603-23, 65753-603-24, 65753-603-26, 65753-603-01, 65753-603-02, 65753-603-35, 65753-603-09, 65753-603-10, 65753-603-25, 65753-603-03, 65753-603-32, 65753-603-33, 65753-603-04, 65753-603-05, 65753-603-07, 65753-603-34, 65753-603-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
THEOBROMA CACAO WHOLEEB048G1S9JIACT
SODIUM HYDROXIDE55X04QC32IIACT
C12-20 ALKYL BENZOATEY15I6XI14CIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-6 SORBITAN OLEATE58O7V09UCIIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
MEDIUM DENSITY POLYETHYLENE3W404QE89SIACT
POLYSORBATE 207T1F30V5YHIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
THEOBROMA CACAO WHOLEEB048G1S9JIACT
SODIUM HYDROXIDE55X04QC32IIACT
C12-20 ALKYL BENZOATEY15I6XI14CIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PEG-6 SORBITAN OLEATE58O7V09UCIIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
MEDIUM DENSITY POLYETHYLENE3W404QE89SIACT
POLYSORBATE 207T1F30V5YHIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CorTex SunX 50 ThickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Incf67a6c6c-c314-1c9d-e053-2a95a90a7f1a2026-04-10WarningsExact identifier
ndc (package): 65753-602-31
ndc (package): 65753-603-09
ndc (package): 65753-603-32
ndc (package): 65753-603-05
ndc (package): 65753-603-34
ndc (package): 65753-603-24
ndc (package): 65753-603-07
ndc (package): 65753-602-26
ndc (package): 65753-603-03
ndc (package): 65753-603-25
ndc (package): 65753-602-23
ndc (package): 65753-603-08
ndc (package): 65753-603-33
ndc (package): 65753-603-23
ndc (package): 65753-603-10
ndc (package): 65753-603-26
ndc (package): 65753-603-04
ndc (package): 65753-603-39
ndc (package): 65753-603-01
ndc (package): 65753-603-22
ndc (package): 65753-602-24
ndc (package): 65753-603-02
ndc (package): 65753-602-22
ndc (package): 65753-603-35
ndc (product): 65753-602
ndc (product): 65753-603
ndc11 (package): 65753060226
ndc11 (package): 65753060303
ndc11 (package): 65753060307
ndc11 (package): 65753060305
ndc11 (package): 65753060302
ndc11 (package): 65753060339
ndc11 (package): 65753060334
ndc11 (package): 65753060301
ndc11 (package): 65753060304
ndc11 (package): 65753060323
ndc11 (package): 65753060325
ndc11 (package): 65753060324
ndc11 (package): 65753060224
ndc11 (package): 65753060308
ndc11 (package): 65753060222
ndc11 (package): 65753060309
ndc11 (package): 65753060326
ndc11 (package): 65753060231
ndc11 (package): 65753060322
ndc11 (package): 65753060335
ndc11 (package): 65753060333
ndc11 (package): 65753060310
ndc11 (package): 65753060332
ndc11 (package): 65753060223
spl id: 4f1d54d8-37c3-ff62-e063-6394a90a458e
spl set id: f67a6c6c-c314-1c9d-e053-2a95a90a7f1a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.