Label: CAY SKIN ISLE BODY OIL SPF 30- avobenzone, homosalate, octisalate, octocrylene oil
- NDC Code(s): 82657-006-01
- 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
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
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- Product Packaging
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INGREDIENTS AND APPEARANCE
CAY SKIN ISLE BODY OIL SPF 30
avobenzone, homosalate, octisalate, octocrylene oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82657-006 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 HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:82657-006-01 1 in 1 CARTON 03/29/2022 1 110 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)
