FDA.reportPublic FDA data

Cay Skin Isle Sheen Sunstick SPF 35

Manufacturer
Cay Skin, Inc.
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:40:48

Label at a glance#

ProductCay Skin Isle Sheen Sunstick SPF 35
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure10 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 (generously) 15 minutes before sun exposure Reapply after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months: ask a doctor 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 value of 15 or higher and other su...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.9%

Homosalate 4.9%

Octisalate 4.9%

Octocrylene 9.5%

Purpose

OTC - PURPOSE SECTION

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 eyes. Rinse with water to remove.

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • rash occurs

Keep out of 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 (generously) 15 minutes before sun exposure
  • Reapply
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months: ask a doctor

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 value of 15 or higher and other sun protection measures including:

  • limit time in the sun, especially from 10 am. - 2 pm
  • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Octyldodecanol, Butyloctyl Salicylate, Ethylhexyl Olivate, Silica Silylate, Dibutyl Lauroyl Glutamide, Polyester-8, Dibutyl Ethylhexanoyl Glutamide, Aloe Barbadensis Leaf Extract, Squalane, Chondrus Crispus Extract, Laminaria Digitata Extract, Laminaria Hyperborea Extract, Carthamus Tinctorius (Safflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrahexyldecyl Ascorbate, Tocopherol, Beta-Sitosterol, Diethylhexyl Syringylidenemalonate.

Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Questions or Comments?

OTC - QUESTIONS SECTION

cayskin.com 1-833-606-1131

Company Information

SPL UNCLASSIFIED SECTION

Distributed by Cay Skin, Inc., Miami, FL 33179

cayskin.com

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82657-007-01Cay Skin Isle Sheen Sunstick SPF 351 in 1 CARTONSTICK11
82657-007-01Cay Skin Isle Sheen Sunstick SPF 3515 g in 1 CONTAINERSTICK151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82657-007CAY SKIN ISLE SHEEN SUNSTICK SPF 35 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) STICK [CAY SKIN, INC.]1Current NDC, 2 package rows20241208_288c3aeb-01b2-ce39-e063-6394a90ad04a.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82657-00782657-007-01

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
OCTISALATE4X49Y0596WACTIB
ETHYLHEXYL OLIVATEHTC7G3S2PVIACT
SQUALANEGW89575KF9IACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CHONDRUS CRISPUSOQS23HUA1XIACT
SAFFLOWER OIL65UEH262ISIACT
JOJOBA OIL724GKU717MIACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TOCOPHEROLR0ZB2556P8IACT
LAMINARIA DIGITATA EXTRACT15E7C67EE8IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
LAMINARIA HYPERBOREA EXTRACTNXA595GQ1KIACT
SUNFLOWER OIL3W1JG795YIIACT
OCTYLDODECANOL461N1O614YIACT
DIBUTYL LAUROYL GLUTAMIDE3V7K3IA58XIACT
OCTOCRYLENE5A68WGF6WMACTIB
DIBUTYL ETHYLHEXANOYL GLUTAMIDE0IAF2L30VSIACT
ALOE VERA LEAFZY81Z83H0XIACT
BETA-SITOSTEROLS347WMO6M4IACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT

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
Cay Skin Isle Sheen Sunstick SPF 35AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECay Skin, Inc.288c3aeb-01b2-ce39-e063-6394a90ad04a2024-12-05WarningsExact identifier
ndc (package): 82657-007-01
ndc (product): 82657-007
ndc11 (package): 82657000701
spl id: 288c3aeb-01b3-ce39-e063-6394a90ad04a
spl set id: 288c3aeb-01b2-ce39-e063-6394a90ad04a

Reported adverse events (FAERS/openFDA)#

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