CAY SKIN ISLE GLOW BODY SPF 45- avobenzone, octisalate, octocrylene lotion

Cay Skin Isle Glow Body SPF 45 by

Drug Labeling and Warnings

Cay Skin Isle Glow Body SPF 45 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 3%, Octisalate 5%, Octocrylene 10%

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 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

• 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

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

INGREDIENTS AND APPEARANCE

CAY SKIN ISLE GLOW BODY SPF 45 
avobenzone, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82657-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)
EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
COCOA BUTTER (UNII: 512OYT1CRR)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
SUNFLOWER OIL (UNII: 3W1JG795YI)
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)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
STANNOUS OXIDE (UNII: JB2MV9I3LS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82657-003-01	1 in 1 CARTON	03/29/2022
1		100 mL in 1 BOTTLE, PUMP; 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	03/29/2022

Labeler - Cay Skin, Inc. (118574309)