Cay Skin Isle Glow Face Lotion SPF 45

Manufacturer
Cay Skin, Inc.
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:09

Label at a glance#

ProductCay Skin Isle Glow Face SPF 45
Active ingredientOCTOCRYLENE, AVOBENZONE, OCTISALATE
Label structure9 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

Adults and children over 6 months of age: Apply liberally 15 minutes before sun exposure. Reapply: at least every 2 hours; immediately after towel drying. Use a water resistant sunscreen if swimming or sweating. Children under 6 months of age: 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 wit...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Octisalate 5%, Octocrylene 10%

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

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

  • Adults and children over 6 months of age:
  • Apply liberally 15 minutes before sun exposure.
  • Reapply: at least every 2 hours; immediately after towel drying.
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 months of age: 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 a.m. - 2 p.m.; wear long-sleeved shirts, pants, hats and sunglasses.

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butyloctyl Salicylate, Sodium Potassium Aluminum Silicate, Diisopropyl Sebacate Diisopropyl Adipate, C12-15 Alkyl Benzoate, Lauryl Lactate, Glycerin, Mica, Propanediol, Glyceryl Stearate, Citrullus Lanatus (Watermelon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculents (Lentil) Fruit Extract, Chondrus Crispus Extract, Panthenol, Niacinamide, Ferulic Add, Helianthus Annuus (Sunflower) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Cetyl Phosphate, Glyceryl Stearate Citrate, Silica, Caprylyl Glycol, 1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Chlorphenesin, Aminomethyl Propanol, Disodium EDTA, Sodium Lactate, Sodium PCA, Vanilla Planifolia Fruit Extract, Santalum Album (Sandalwood) Oi, Rosa Damascena Flower Oil, Myroxylon Pereirae (Balsam Peru) Oil, Cupressus Sempervirens Leaf/Nut/Stem Oil, Coffea Arabica (Coffee) Seed Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Amyris Balsamifera Bark Oil, Sodium Benzoate, Potassium Sorbate, Caprylic/Capric Triglyceride, Limonium Gerberi Extract, Limonene, Linalool, Benzyl Benzoate, Titanium Dioxide, Iron Oxides

Questions or comments?

OTC - QUESTIONS SECTION

cayskin.com (256) 396-8268

Product Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

isle glow faceisle glow face

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82657-002-01Cay Skin Isle Glow Face SPF 451 in 1 CARTONLOTION12
82657-002-01Cay Skin Isle Glow Face SPF 4545 mL in 1 BOTTLE, PUMPLOTION452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82657-002CAY SKIN ISLE GLOW FACE SPF 45 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LOTION [CAY SKIN, INC.]2Current NDC, Legacy NDC, 2 package rows20241208_d91bba06-fd9b-3eb5-e053-2995a90a6124.zip

Products#

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

DailyMed product names page 1 of 2 · 55 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82657-00282657-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 53 matching rows.

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 Glow Face SPF 45AVOBENZONE, OCTISALATE, OCTOCRYLENECay Skin, Inc.d91bba06-fd9b-3eb5-e053-2995a90a61242024-12-05WarningsExact identifier
ndc (package): 82657-002-01
ndc (product): 82657-002
ndc11 (package): 82657000201
spl id: 2889f129-f28a-1164-e063-6394a90a688d
spl set id: d91bba06-fd9b-3eb5-e053-2995a90a6124

Reported adverse events (FAERS/openFDA)#

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