FDA.reportPublic FDA data

CoreTex Sun X 50

Manufacturer
CoreTex Products Inc | Health Specialty
Effective date
2022-11-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:46:49

Label at a glance#

ProductCoreTex Sun X 50
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure9 sections

Indications and uses

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

Dosage and administration

apply generously and evenly 15 minutes before sun exposure Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or ;higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm wear long-sleeved shirt, pants, hat and sunglasses reapp...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone

Homosalate

Octisalate

Octocrylene

Purpose

OTC - PURPOSE SECTION

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn
  • if used as directed with other 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 eyes. Rinse with water to remove

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash occurs

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 generously and evenly 15 minutes before sun exposure

Sun Protection Measures: spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or ;higher and other sun protection measures including:

  • limit time in the sun, especially from 10 am to 2 pm
  • wear long-sleeved shirt, pants, hat and sunglasses

reapply

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every two hours

Children under 6 months of age: Ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • protect the product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, caprylyl methicone, cetyl PEG/PPG-10-1 dimethicone, dicaprylyl ether, edetate disodium, ethylhexylglycerin,glycereth-2 cocoate, stearyl/octyldodecyl citrate crosspolymer, phenoxyethanol, propylene glycol, sodium chloride, water

Questions?

OTC - QUESTIONS SECTION

Call 1-877-684-5774

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun X50Sun X50

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65753-60065753-600-01, 65753-600-32, 65753-600-02, 65753-600-33, 65753-600-03, 65753-600-34, 65753-600-04, 65753-600-05, 65753-600-07, 65753-600-08, 65753-600-09, 65753-600-10, 65753-600-39, 65753-600-22, 65753-600-23, 65753-600-24, 65753-600-25, 65753-600-26

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CHLORIDE451W47IQ8XIACT
OCTISALATE4X49Y0596WACTIB
BENZOIC ACID8SKN0B0MIMIACT
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
DICAPRYLYL ETHER77JZM5516ZIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)V2W71V8T0XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
MYRISTYL TRISILOXANEJ7960S4R1TIACT
OCTYLDODECYL STEARATEK6F16QGO28IACT
GLYCERETH-2 COCOATEJWM00VS7HCIACT
PROPYLENE GLYCOL6DC9Q167V3IACT

Source Document#

Source XML · Source PDF

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
f88f8fba-f5d0-7f91-e053-6394a90a18778ff55d72-2f9d-065b-e053-2995a90a8b1f2023-04-04WarningsExact identifier
spl set id: 8ff55d72-2f9d-065b-e053-2995a90a8b1f

Reported adverse events (FAERS/openFDA)#

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