FDA.reportPublic FDA data

CoreTex SunX 50 Facestick

Manufacturer
CoreTex Products Inc
Effective date
2025-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:01:49

Label at a glance#

ProductCoreTex SunX 50 Facestick
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, HOMOSALATE
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 liberally (or 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 a.m. to 2 p.m. wear long-sleeved shirt, pants, hat an...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 5%

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 liberally (or 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 a.m. to 2 p.m.
  • wear long-sleeved shirt, pants, hat and sunglasses

reapply

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 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

aloe bardensis leaf extract, beeswax, butyrospermum parkii (shea) butter, C12-15 alkyl benzoate, caprylic/capric triglyceride, ethylhexylglycerin, helianthus annuus (sunflower) seed oil, olea europaea (olive) fruit oil, ozokerite, phenoxyethanol, theobroma cacao (cocoa) seed butter, tocopheryl acetate, vp/hexadecene copolymer, zinc oxide

Questions?

OTC - QUESTIONS SECTION

Call 1-877-684-5774

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SunX 50 facestickSunX 50 facestick

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-707-40CoreTex SunX 50 Facestick14.2 g in 1 APPLICATORSTICK14.21

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65753-70765753-707-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDEU73D397055IACT
AVOBENZONEG63QQF2NOXACTIB
SHEA BUTTERK49155WL9YIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
OLEA EUROPAEA (OLIVE) FRUIT OIL6UYK2W1W1EIACT
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VP/HEXADECENE COPOLYMERKFR5QEN0N9IACT
ZINC OXIDESOI2LOH54ZIACT
HOMOSALATEV06SV4M95SACTIB
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
BEESWAX2ZA36H0S2VIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PARAFFINI9O0E3H2ZEIACT

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 SunX 50 FacestickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc364989ea-c93b-d404-e063-6294a90abd092025-05-28WarningsExact identifier
ndc (package): 65753-707-40
ndc (product): 65753-707
ndc11 (package): 65753070740
spl id: 364989fa-e07d-89f7-e063-6394a90a7887
spl set id: 364989ea-c93b-d404-e063-6294a90abd09

Reported adverse events (FAERS/openFDA)#

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