Label: CAY SKIN ISLE GLOW BODY SPF 45- avobenzone, octisalate, octocrylene lotion
- NDC Code(s): 82657-003-01
- Packager: Cay Skin, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated March 29, 2022
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purpose
- Uses
- Warnings
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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
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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)
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INGREDIENTS AND APPEARANCE
CAY SKIN ISLE GLOW BODY SPF 45
avobenzone, octisalate, octocrylene lotionProduct 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) 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 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 not final part352 03/29/2022 Labeler - Cay Skin, Inc. (118574309)
