FDA.reportPublic FDA data

CoreTex Sun X SPF 30 Thin

Manufacturer
CoreTex Products Inc | Pure Source
Effective date
2023-10-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:57:13

Label at a glance#

ProductCoreTex Sun X SPF 30 Thin
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE
Label structure10 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 1.0%

Homosalate 5.0%

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 6.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

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 eye. 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 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 (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?

OTC - QUESTIONS SECTION

Call: 1-877-684-5774

Principal Display Panel 101-12

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

101101

101-11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

101-11101-11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-101-11CoreTex Sun X SPF 30 Thin59 mL in 1 BOTTLE, SPRAYLIQUID596
65753-101-12CoreTex Sun X SPF 30 Thin118 mL in 1 BOTTLE, SPRAYLIQUID1186
65753-101-22CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-22CoreTex Sun X SPF 30 Thin25 in 1 CONTAINERLIQUID256
65753-101-23CoreTex Sun X SPF 30 Thin50 in 1 CONTAINERLIQUID506
65753-101-23CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-24CoreTex Sun X SPF 30 Thin50 in 1 CARTONLIQUID506
65753-101-24CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-25CoreTex Sun X SPF 30 Thin100 in 1 CARTONLIQUID1006
65753-101-25CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-26CoreTex Sun X SPF 30 Thin300 in 1 BOXLIQUID3006
65753-101-26CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-27CoreTex Sun X SPF 30 Thin7 mL in 1 PACKETLIQUID76
65753-101-27CoreTex Sun X SPF 30 Thin16 in 1 BOXLIQUID166

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-101CORETEX SUN X SPF 30 THIN (AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE) LIQUID [CORETEX PRODUCTS INC]6Current NDC, Legacy NDC, 14 package rows20231022_980388b5-8314-3143-e053-2995a90a7288.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65753-10165753-101-11, 65753-101-12, 65753-101-27, 65753-101-22, 65753-101-23, 65753-101-24, 65753-101-25, 65753-101-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DIMETHYL CAPRAMIDEO29Y6X2JEZIACT
DIMETHICONE92RU3N3Y1OIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TROLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
BUTYLPARABEN3QPI1U3FV8IACT
ISOBUTYLPARABEN0QQJ25X58GIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CHAMOMILEFGL3685T2XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
PEG-100 STEARATEYD01N1999RIACT
NASTURTIUM OFFICINALEYH89GMV676IACT
COMFREY LEAFDG4F8T839XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
TETRASODIUM EDETATE DIHYDRATE3JGX4KKZ4AIACT
FRAGRANCE 135765EM498GW35IACT
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 ThinAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONECoreTex Products Inc980388b5-8314-3143-e053-2995a90a72882023-10-22WarningsExact identifier
ndc (package): 65753-101-27
ndc (package): 65753-101-22
ndc (package): 65753-101-23
ndc (package): 65753-101-26
ndc (package): 65753-101-11
ndc (package): 65753-101-12
ndc (package): 65753-101-25
ndc (package): 65753-101-24
ndc (product): 65753-101
ndc11 (package): 65753010111
ndc11 (package): 65753010126
ndc11 (package): 65753010124
ndc11 (package): 65753010125
ndc11 (package): 65753010112
ndc11 (package): 65753010123
ndc11 (package): 65753010127
ndc11 (package): 65753010122
spl id: 0847f22b-ece4-e4c1-e063-6394a90a4d62
spl set id: 980388b5-8314-3143-e053-2995a90a7288

Reported adverse events (FAERS/openFDA)#

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