CAY SKIN ISLE GLOW FACE 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 Face 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, 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?

cayskin.com (256) 396-8268

Product Packaging

isle glow face

CAY SKIN ISLE GLOW FACE SPF 45 
avobenzone, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-002
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
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
PANTHENOL (UNII: WV9CM0O67Z)  
NIACINAMIDE (UNII: 25X51I8RD4)  
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)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
BALSAM PERU OIL (UNII: DIK0395679)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
SANDALWOOD OIL (UNII: X7X01WMQ5F)  
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F)  
BENZYL BENZOATE (UNII: N863NB338G)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
VANILLA (UNII: Q74T35078H)  
ARABICA COFFEE OIL (UNII: IK55HKE887)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
BITTER ORANGE OIL (UNII: 9TLV70SV6I)  
CUPRESSUS SEMPERVIRENS WHOLE (UNII: V0IW9P606J)  
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)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82657-002-011 in 1 CARTON03/29/2022
145 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: 2/2022
Document Id: d91bba06-fd9c-3eb5-e053-2995a90a6124
Set id: d91bba06-fd9b-3eb5-e053-2995a90a6124
Version: 1
Effective Time: 20220228
 
Cay Skin, Inc.