CAY SKIN ISLE BODY OIL SPF 30- avobenzone, homosalate, octisalate, octocrylene oil 
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 Body Oil SPF 30

Drug Facts

Active ingredients

Avobenzone 3%

Homosalate 10%

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.

Flammable

Do not use near heat, flame, or while smoking.

Directions

Other information

Protect this product from excessive heat and direct sun.

Inactive ingredients

Alcohol, C12-15 Alkyl Benzoate, Octyldodecanol, Dibutyl Adipate, Caprylic/CapricTriglyceride, Diethylhexyl Carbonate, Diisopropyl Sebacate, Polyester-8, Lauryl Lactate, Polyamide-3, Persea Gratissima (Avocado) Oil Chondrus Crispus Extract, Alaria Esculenta Extract, Tocopheryl Acetate, Vitis Vinifera (Grape) Seed Oil, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Cucumis Sativus (Cucumber) Fruit Extract Heliarrthus Annuus (Sunflower) Seed Extract, Hordeum Vulgare Extract, Salicornia Herbacea Extract, Squalane, Glycerin, Raphanus Sativus (Radish) Seed Extract, Glycine Soja (Soybean) Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Amyris Balsamifera Bark Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Coffea Arabica (Coffee) Seed Oil, Cupressus Sempervirens Leaf/Nut/Stem Oil, Helianthus Annuus (Sunflower) Seed Oil, Myroxylon Pereirae (Balsam Peru) Oil, Rosa Damascena Flower Oil, Santalum Album (Sandalwood) Oil, Vanilla Planifolia Fruit Extract, Diethylhexyl Syringlidenemalonate, PentaerythrityI Tetra-di-t-butyI Hydroxyhydrocinnamate, Citric Acid

Questions or comments?

cayskin.com (256) 396-8268

Product Packaging

body oil

CAY SKIN ISLE BODY OIL SPF 30 
avobenzone, homosalate, octisalate, octocrylene oil
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-006
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
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
ARGAN OIL (UNII: 4V59G5UW9X)  
SQUALANE (UNII: GW89575KF9)  
SOYBEAN OIL (UNII: 241ATL177A)  
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
VANILLA BEAN (UNII: Q74T35078H)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
CUCUMBER (UNII: YY7C30VXJT)  
SALICORNIA EUROPAEA WHOLE (UNII: 6ADL50JAKW)  
RAPHANUS SATIVUS VAR. SATIVUS SEED (UNII: A94I086Q5E)  
CUPRESSUS SEMPERVIRENS WHOLE (UNII: V0IW9P606J)  
SUNFLOWER OIL (UNII: 3W1JG795YI)  
ROSA DAMASCENA FLOWER OIL (UNII: 18920M3T13)  
ALCOHOL (UNII: 3K9958V90M)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
DIBUTYL ADIPATE (UNII: F4K100DXP3)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
LAURYL LACTATE (UNII: G5SU0BFK7O)  
AMYRIS BALSAMIFERA OIL (UNII: I1BJ961J2E)  
ARABICA COFFEE OIL (UNII: IK55HKE887)  
BALSAM PERU OIL (UNII: DIK0395679)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
AVOCADO OIL (UNII: 6VNO72PFC1)  
CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
GRAPE SEED OIL (UNII: 930MLC8XGG)  
SANDALWOOD OIL (UNII: X7X01WMQ5F)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
HORDEUM VULGARE WHOLE (UNII: 8JBE478M5Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)  
ALARIA ESCULENTA (UNII: EJ9JK8J58D)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82657-006-011 in 1 CARTON03/29/2022
1110 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: d91b2097-9272-21d0-e053-2a95a90ac39f
Set id: d91b2097-9271-21d0-e053-2a95a90ac39f
Version: 1
Effective Time: 20220228
 
Cay Skin, Inc.