CAY SKIN ISLE GLOW BODY SPF 45- avobenzone, octisalate, octocrylene lotion 
Cay Skin, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Cay Skin Isle Glow Body Lotion SPF 45

Drug Facts

Active ingredients

Avobenzone 3%, Octisalate 5%, Octocrylene 10%

Purpose

Sunscreen

Uses

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and consult a doctor

if skin rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Protect this product from excessive heat and direct sun.

Inactive ingredients

Water, C12-15 Alkyl Benzoate, Butyloctyl Salicylate, Sodium Potassium Aluminum Silicate, Diisopropyl Sebacate, Diisopropyl Adipate, Lauryl Lactate, Mica, Propanediol, Glyceryl Stearate, VP/Eicosene Copolylmer, Chondrus Crispus Extract, Limonium Gerberi Extract, Ferulic Acid, Citrullus Lanatus (Watermelon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculents (Lentil) Fruit Extract, Helianthus Annuus (Sunflower) Seed Oil, Theobroma Cacao (Cocoa) Seed Butter, Glycerin, Caprylic/Capric Triglyceride, Cetyl Phosphate, Glyceryl Stearate Citrate, Silica, Ethylene Brassylate, Caprylyl Glycol, 1,2-Hexanediol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Sodium Lactate, Sodium PCA, Sodium Benzoate, Potassium Sorbate, Disodium EDTA, Chlorphenesin, Synthetic Fluorphlogopite, Tin Oxide, CI 77891 (Titanium Dioxide), CI 77491 (Iron Oxides)

Questions or comments?

cayskin.com (256) 396-8268

Product Packaging

isle glow body

CAY SKIN ISLE GLOW BODY SPF 45 
avobenzone, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)  
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
COCOA BUTTER (UNII: 512OYT1CRR)  
CETYL PHOSPHATE (UNII: VT07D6X67O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
MICA (UNII: V8A1AW0880)  
PROPANEDIOL (UNII: 5965N8W85T)  
APPLE (UNII: B423VGH5S9)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
WATERMELON (UNII: 231473QB6R)  
LENTIL (UNII: 6O38V6B52O)  
FERULIC ACID (UNII: AVM951ZWST)  
STANNOUS OXIDE (UNII: JB2MV9I3LS)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82657-003-011 in 1 CARTON03/29/2022
1100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/29/2022
Labeler - Cay Skin, Inc. (118574309)

Revised: 3/2022
Document Id: db5f6bad-65ad-2b05-e053-2a95a90a8569
Set id: db5f6bad-65ae-2b05-e053-2a95a90a8569
Version: 1
Effective Time: 20220329
 
Cay Skin, Inc.