FDA.reportPublic FDA data

SunX SPF 30/BugX Wallmount

Manufacturer
CoreTex Products Inc | Pure Source
Effective date
2023-10-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:57:11

Label at a glance#

ProductSunX SPF 30/BugX Wallmount
Active ingredientHOMOSALATE, OCTINOXATE, OCTISALATE, AVOBENZONE, OXYBENZONE
Label structure11 sections

Indications and uses

helps prevent sunburn higher SPF gives more sunburn protetion. 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 protetion.
  • 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 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 or 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, ethylexylglycerin, hydroxypropyl methylcellulose, phenoxyethanol, polyethylene, polysorbate 20, propylene glycol, sodium hydroxide, soritan oleate, theobroma cacao (cocoa) seed butter, tocopherol, tocopheryl acetate, water

Questions?

OTC - QUESTIONS SECTION

Call: 1-877-684-5774

SunX/BugX Kit Contents

SPL UNCLASSIFIED SECTION

50 count- SunX SPF 30, BugX 30

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

suns-bugxfrsuns-bugxfr

SunX SPF 30 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunxlotion pouchsunxlotion pouch

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130698229918444GTIN-13: 0698229918444
EAN-13: 0698229918444
GTIN-12: 698229918444
UPC-A: 698229918444
GTIN storage (14 digits): 00698229918444		sunX30-bugfr-wallmount.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-101-10SunX SPF 30/BugX Wallmount7 mL in 1 POUCHLIQUID350 mL7.5 g in 100mL1
65753-511-24SunX SPF 30/BugX Wallmount1 in 1 KITKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-101SUNX SPF 30/BUGX WALLMOUNT KIT [CORETEX PRODUCTS INC]1Current NDC, Legacy NDC20231022_08480b2a-a888-fb00-e063-6294a90a41ea.zip
65753-511SUNX SPF 30/BUGX WALLMOUNT KIT [CORETEX PRODUCTS INC]1Current NDC, 2 package rows20231022_08480b2a-a888-fb00-e063-6294a90a41ea.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65753-10165753-101-10
65753-51165753-511-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL 1-CAPRYLATETL885HYH94IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
EDETATE DISODIUM7FLD91C86KIACT
PEG-6 SORBITAN OLEATE58O7V09UCIIACT
THEOBROMA CACAO WHOLEEB048G1S9JIACT
SODIUM HYDROXIDE55X04QC32IIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
MEDIUM DENSITY POLYETHYLENE3W404QE89SIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
AVOBENZONEG63QQF2NOXACTIB
OXYBENZONE95OOS7VE0YACTIB
PEG-100 STEARATEYD01N1999RIACT

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SunX SPF 30/BugX WallmountSUNX SPF 30/BUGX WALLMOUNTCoreTex Products Inc08480b2a-a888-fb00-e063-6294a90a41ea2023-10-22WarningsExact identifier
ndc (package): 65753-101-10
ndc (package): 65753-511-24
ndc (product): 65753-511
ndc11 (package): 65753010110
ndc11 (package): 65753051124
spl id: 0847d369-49f0-6807-e063-6294a90afc84
spl set id: 08480b2a-a888-fb00-e063-6294a90a41ea
CoreTex Sun X SPF 30 ThinAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONECoreTex Products Inc980388b5-8314-3143-e053-2995a90a72882023-10-22WarningsExact identifier
ndc (product): 65753-101
SunX SPF 30/BugX WallmountSUNX SPF 30/BUGX WALLMOUNTCoreTex Products Inc0846946b-a05d-826c-e063-6294a90a0a0f2023-10-11WarningsExact identifier
ndc (package): 65753-101-10
ndc11 (package): 65753010110

Reported adverse events (FAERS/openFDA)#

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