FDA.reportPublic FDA data

CoreTex Sun X SPF 30 New

Manufacturer
CoreTex Products Inc | Prime Enterprises
Effective date
2023-10-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:58:24

Label at a glance#

ProductCoreTex Sun X SPF 30 New
Active ingredientOCTOCRYLENE, AVOBENZONE, HOMOSALATE, OCTISALATE
Label structure9 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweatingchildren under 6 months of age: Ask a doctor immediately after towel drying at least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocylene 5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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

OTC - STOP USE SECTION

if rash occurs

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 sweatingchildren under 6 months of age: Ask a doctor
    • immediately after towel drying
    • at least every 2 hours

Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10:00 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • children under 6 months: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat or direct 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, tocopherol acetate, water

Questions and comments?

OTC - QUESTIONS SECTION

Call: 1-877-684-5774

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SunX30thicknewSunX30thicknew

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-110-01CoreTex Sun X SPF 30 New30 mL in 1 BOTTLE, PLASTICLOTION301
65753-110-02CoreTex Sun X SPF 30 New59 mL in 1 BOTTLE, PLASTICLOTION591
65753-110-03CoreTex Sun X SPF 30 New118 mL in 1 BOTTLE, PLASTICLOTION1181
65753-110-04CoreTex Sun X SPF 30 New177 mL in 1 BOTTLE, PLASTICLOTION1771
65753-110-05CoreTex Sun X SPF 30 New236 mL in 1 BOTTLE, PLASTICLOTION2361
65753-110-07CoreTex Sun X SPF 30 New473 mL in 1 BOTTLE, PLASTICLOTION4731
65753-110-08CoreTex Sun X SPF 30 New500 mL in 1 BAGLOTION5001
65753-110-08CoreTex Sun X SPF 30 New1 in 1 BOXLOTION11
65753-110-09CoreTex Sun X SPF 30 New946 mL in 1 BOTTLE, PLASTICLOTION9461
65753-110-10CoreTex Sun X SPF 30 New3785 mL in 1 BOTTLE, PLASTICLOTION37851
65753-110-18CoreTex Sun X SPF 30 New1000 in 1 CARTONLOTION10001
65753-110-18CoreTex Sun X SPF 30 New44 mL in 1 PACKETLOTION441
65753-110-22CoreTex Sun X SPF 30 New7 mL in 1 PACKETLOTION71
65753-110-22CoreTex Sun X SPF 30 New25 in 1 CONTAINERLOTION251
65753-110-23CoreTex Sun X SPF 30 New7 mL in 1 PACKETLOTION71
65753-110-23CoreTex Sun X SPF 30 New50 in 1 CONTAINERLOTION501
65753-110-24CoreTex Sun X SPF 30 New50 in 1 CARTONLOTION501
65753-110-24CoreTex Sun X SPF 30 New7 mL in 1 PACKETLOTION71
65753-110-25CoreTex Sun X SPF 30 New7 mL in 1 PACKETLOTION71
65753-110-25CoreTex Sun X SPF 30 New100 in 1 CARTONLOTION1001
65753-110-26CoreTex Sun X SPF 30 New7 mL in 1 PACKETLOTION71
65753-110-26CoreTex Sun X SPF 30 New300 in 1 BOXLOTION3001
65753-110-32CoreTex Sun X SPF 30 New44 mL in 1 BOTTLE, PLASTICLOTION441
65753-110-33CoreTex Sun X SPF 30 New59 mL in 1 BOTTLE, PLASTICLOTION591
65753-110-34CoreTex Sun X SPF 30 New118 mL in 1 BOTTLE, PLASTICLOTION1181
65753-110-35CoreTex Sun X SPF 30 New751 mL in 1 BOTTLELOTION7511
65753-110-37CoreTex Sun X SPF 30 New44 mL in 1 PACKETLOTION441
65753-110-40CoreTex Sun X SPF 30 New1 in 1 BOXLOTION11
65753-110-40CoreTex Sun X SPF 30 New751 mL in 1 BOTTLELOTION7511

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-110CORETEX SUN X SPF 30 NEW (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [CORETEX PRODUCTS INC]1Current NDC, 29 package rows20231031_08fb4748-d22d-35af-e063-6394a90a0827.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
65753-11065753-110-01, 65753-110-32, 65753-110-02, 65753-110-33, 65753-110-03, 65753-110-34, 65753-110-04, 65753-110-05, 65753-110-07, 65753-110-09, 65753-110-10, 65753-110-37, 65753-110-18, 65753-110-22, 65753-110-23, 65753-110-24, 65753-110-25, 65753-110-26, 65753-110-08, 65753-110-40, 65753-110-35

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 NewAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc08fb4748-d22d-35af-e063-6394a90a08272023-10-30WarningsExact identifier
ndc (package): 65753-110-34
ndc (package): 65753-110-18
ndc (package): 65753-110-26
ndc (package): 65753-110-40
ndc (package): 65753-110-25
ndc (package): 65753-110-04
ndc (package): 65753-110-33
ndc (package): 65753-110-02
ndc (package): 65753-110-10
ndc (package): 65753-110-37
ndc (package): 65753-110-09
ndc (package): 65753-110-01
ndc (package): 65753-110-22
ndc (package): 65753-110-03
ndc (package): 65753-110-08
ndc (package): 65753-110-05
ndc (package): 65753-110-32
ndc (package): 65753-110-07
ndc (package): 65753-110-23
ndc (package): 65753-110-24
ndc (package): 65753-110-35
ndc (product): 65753-110
ndc11 (package): 65753011035
ndc11 (package): 65753011024
ndc11 (package): 65753011037
ndc11 (package): 65753011040
ndc11 (package): 65753011004
ndc11 (package): 65753011025
ndc11 (package): 65753011009
ndc11 (package): 65753011010
ndc11 (package): 65753011002
ndc11 (package): 65753011007
ndc11 (package): 65753011023
ndc11 (package): 65753011026
ndc11 (package): 65753011034
ndc11 (package): 65753011003
ndc11 (package): 65753011032
ndc11 (package): 65753011018
ndc11 (package): 65753011005
ndc11 (package): 65753011022
ndc11 (package): 65753011001
ndc11 (package): 65753011008
ndc11 (package): 65753011033
spl id: 08fb1bbf-f361-29da-e063-6394a90aa397
spl set id: 08fb4748-d22d-35af-e063-6394a90a0827

Reported adverse events (FAERS/openFDA)#

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