FDA.reportPublic FDA data

CoreTex Sun X SPF 30 Multipack New

Manufacturer
CoreTex Products | Prime Enterprises
Effective date
2023-10-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:15

Label at a glance#

ProductCoreTex Sun X SPF 30 Multipack New
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure11 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 7.5%

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 the 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 the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is 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

SPL UNCLASSIFIED SECTION

  • 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 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?

OTC - QUESTIONS SECTION

Call: 1-877-684-5774

Kit Contents

SPL UNCLASSIFIED SECTION

1-Towelette

65753-109-22-23-31-26

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunxpouchsunxpouch

65753-109-24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

109-24109-24

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-109-22CoreTex Sun X SPF 30 Multipack New25 in 1 CONTAINERLOTION253
65753-109-22CoreTex Sun X SPF 30 Multipack New7 g in 1 POUCHLOTION73
65753-109-23CoreTex Sun X SPF 30 Multipack New25 in 1 CONTAINERLOTION253
65753-109-23CoreTex Sun X SPF 30 Multipack New7 g in 1 POUCHLOTION73
65753-109-24CoreTex Sun X SPF 30 Multipack New7 g in 1 POUCHLOTION73
65753-109-24CoreTex Sun X SPF 30 Multipack New50 in 1 CONTAINERLOTION503
65753-109-26CoreTex Sun X SPF 30 Multipack New300 in 1 BOXLOTION3003
65753-109-26CoreTex Sun X SPF 30 Multipack New7 g in 1 POUCHLOTION73
65753-109-31CoreTex Sun X SPF 30 Multipack New7 g in 1 POUCHLOTION73
65753-109-31CoreTex Sun X SPF 30 Multipack New150 in 1 BOXLOTION1503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-109CORETEX SUN X SPF 30 MULTIPACK NEW (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CORETEX PRODUCTS]3Current NDC, 10 package rows20231022_f4ed9d7f-2d03-87d1-e053-2a95a90a3b4f.zip

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
65753-10965753-109-22, 65753-109-23, 65753-109-24, 65753-109-31, 65753-109-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
SODIUM HYDROXIDE55X04QC32IIACT
PEG-6 SORBITAN OLEATE58O7V09UCIIACT
THEOBROMA CACAO WHOLEEB048G1S9JIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POLYSORBATE 207T1F30V5YHIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
PROPYLENE GLYCOL PROPYL ETHER92KA3PYX0SIACT
MEDIUM DENSITY POLYETHYLENE3W404QE89SIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT

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
CoreTex Sun X SPF 30 Multipack NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Productsf4ed9d7f-2d03-87d1-e053-2a95a90a3b4f2023-10-22WarningsExact identifier
ndc (package): 65753-109-22
ndc (package): 65753-109-26
ndc (package): 65753-109-23
ndc (package): 65753-109-31
ndc (package): 65753-109-24
ndc (product): 65753-109
ndc11 (package): 65753010922
ndc11 (package): 65753010923
ndc11 (package): 65753010924
ndc11 (package): 65753010926
ndc11 (package): 65753010931
spl id: 084870bb-b526-c6af-e063-6394a90a1609
spl set id: f4ed9d7f-2d03-87d1-e053-2a95a90a3b4f

Reported adverse events (FAERS/openFDA)#

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