FDA.reportPublic FDA data

Cay Skin Isle Nourishing Body Mist SPF 50

Manufacturer
Cay Skin, Inc.
Effective date
2025-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:09

Label at a glance#

ProductCay Skin Isle Nourishing Body Mist SPF 50
Active ingredientAVOBENZONE, OCTISALATE, 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 15 minutes before sun exposure. Hold 4 to 6 inches away from body when spraying. Children under 6 months of age: Ask a doctor. Do not spray directly on face and avoid breathing mist. Spray on hand and apply to face. Use in well-ventilated areas. 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 w...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octisalate 5%

Octocrylene 8%

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.

Flammable.

SPL UNCLASSIFIED SECTION

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.
  • Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120F.

Stop use and consult a doctor

OTC - STOP USE SECTION

if skin 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 15 minutes before sun exposure.
  • Hold 4 to 6 inches away from body when spraying.
  • Children under 6 months of age: Ask a doctor.
  • Do not spray directly on face and avoid breathing mist.
  • Spray on hand and apply to face. Use in well-ventilated areas.
  • 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 protections measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses.
  • Reapply:
  • after 80 minutes of running or sweating
  • immediately after towel use or at least every two hours.

Other information

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun.
  • May stain some fabrics.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat., Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Butyloctyl Salicylate, Chondrus Crispus Extract, Diisopropyl Adipate, Opuntia Ficus-Indica Extract, Parfum (Fragrance), Sodium Hyaluronate, Tocopheryl Acetate

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
82657-009-01Cay Skin Isle Nourishing Body Mist SPF 50171 g in 1 CANAEROSOL, SPRAY1711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82657-009CAY SKIN ISLE NOURISHING BODY MIST SPF 50 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) AEROSOL, SPRAY [CAY SKIN, INC.]11 package rows20250228_2bd90249-30fd-dc62-e063-6394a90a9ffa.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82657-00982657-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM HYALURONATEYSE9PPT4THIACT
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW)7LL6SY9YFVIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ALOE VERA LEAFZY81Z83H0XIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
ALCOHOL3K9958V90MIACT
ASCORBYL PALMITATEQN83US2B0NIACT
OPUNTIA FICUS-INDICA23Z87HTQ6PIACT
CHONDRUS CRISPUSOQS23HUA1XIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT

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
2bd901f6-c9be-134c-e063-6294a90ae8f92bd90249-30fd-dc62-e063-6394a90a9ffa2025-01-16WarningsExact identifier
spl id: 2bd901f6-c9be-134c-e063-6294a90ae8f9
spl set id: 2bd90249-30fd-dc62-e063-6394a90a9ffa

Reported adverse events (FAERS/openFDA)#

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