Label: CAY SKIN ISLE GLOW FACE SPF 45- avobenzone, octisalate, octocrylene lotion
- NDC Code(s): 82657-002-01
- 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 February 28, 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, 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
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- Product Packaging
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INGREDIENTS AND APPEARANCE
CAY SKIN ISLE GLOW FACE SPF 45
avobenzone, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82657-002 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 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82657-002-01 1 in 1 CARTON 03/29/2022 1 45 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)
