CAY SKIN ISLE SHEEN SUNSTICK SPF 35- avobenzone, homosalate, octisalate, octocrylene stick

Cay Skin Isle Sheen Sunstick SPF 35 by

Drug Labeling and Warnings

Cay Skin Isle Sheen Sunstick SPF 35 by is a Otc medication manufactured, distributed, or labeled by Cay Skin, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 2.9%

Homosalate 4.9%

Octisalate 4.9%

Octocrylene 9.5%

Purpose

Sunscreen

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.

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

• rash occurs

Keep out of reach of children.

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

Directions

• Apply liberally (generously) 15 minutes before sun exposure
• Reapply
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• children under 6 months: 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 am. - 2 pm
• wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Caprylic/Capric Triglyceride, Octyldodecanol, Butyloctyl Salicylate, Ethylhexyl Olivate, Silica Silylate, Dibutyl Lauroyl Glutamide, Polyester-8, Dibutyl Ethylhexanoyl Glutamide, Aloe Barbadensis Leaf Extract, Squalane, Chondrus Crispus Extract, Laminaria Digitata Extract, Laminaria Hyperborea Extract, Carthamus Tinctorius (Safflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tetrahexyldecyl Ascorbate, Tocopherol, Beta-Sitosterol, Diethylhexyl Syringylidenemalonate.

Other Information

Protect this product from excessive heat and direct sun.

Questions or Comments?

cayskin.com 1-833-606-1131

Company Information

Distributed by Cay Skin, Inc., Miami, FL 33179

cayskin.com

Product Labeling

INGREDIENTS AND APPEARANCE

CAY SKIN ISLE SHEEN SUNSTICK SPF 35 
avobenzone, homosalate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82657-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	49 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	29 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	49 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	95 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYL OLIVATE (UNII: HTC7G3S2PV)
SQUALANE (UNII: GW89575KF9)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
SAFFLOWER OIL (UNII: 65UEH262IS)
JOJOBA OIL (UNII: 724GKU717M)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
LAMINARIA DIGITATA EXTRACT (UNII: 15E7C67EE8)
LAMINARIA HYPERBOREA EXTRACT (UNII: NXA595GQ1K)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OCTYLDODECANOL (UNII: 461N1O614Y)
DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BETA-SITOSTEROL (UNII: S347WMO6M4)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82657-007-01	1 in 1 CARTON	07/19/2024
1		15 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/19/2024

Labeler - Cay Skin, Inc. (118574309)