Label: CAY SKIN UNIVERSAL MINERAL BODY SPF 55- zinc oxide lotion
- NDC Code(s): 82657-004-01
- 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 1, 2022
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- Drug Facts
- Active ingredients
- 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 or after 80 minutes of swimming, sweating or immediately after towel drying.
- 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, Caprylic/Capric Triglyceride, Propanediol, Tridecyl Salicylate, Coco-Caprylate, Simmondsia Chinensis (Jojoba) Seed Oil, Isopropyl Isostearate, Squalane, Polyester-7, Cyclodextrin, Glyceryl Stearate, Neopentyl Glycol Diheptanoate, Polyglyceryl-3 Polyricinoleate, Sodium Chloride, Siica Silylate, Siica, Polyglyceryl-2 Dpolyhydroxystearate, Glycerin, Glyceryl Dibehenate, Bisabolol, Phenylpropanol, Allantoin, Rutin, Tribehenin, Caprylyl Glycol, Lecithin, Glyceryl Behenate, Citrullus Lanatus (Watermelon) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Aloe Barbadensis Leaf Juice Powder, Maltodextrin, Sodium Lactate, Sodium Hyaluronate, Chondrus Crispus Extract, Vrtis Vinifera (Grape) Seed Extract, Iron Oxides, Sodium PCA, Potassium Sorbate, Sodium Benzoate, Tocopherol, Camellia Sinensis Leaf Extract, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Hydrogenated Lecithin
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INGREDIENTS AND APPEARANCE
CAY SKIN UNIVERSAL MINERAL BODY SPF 55
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82657-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength LEVOMENOL (UNII: 24WE03BX2T) RUTIN (UNII: 5G06TVY3R7) CAPRYLYL GLYCOL (UNII: 00YIU5438U) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) SQUALANE (UNII: GW89575KF9) CYCLODEXTRINS (UNII: 7E6SK9QDT8) POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) COCO-CAPRYLATE (UNII: 4828G836N6) JOJOBA OIL (UNII: 724GKU717M) ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL DIBEHENATE (UNII: R8WTH25YS2) LENTIL (UNII: 6O38V6B52O) APPLE (UNII: B423VGH5S9) SODIUM CHLORIDE (UNII: 451W47IQ8X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENYLPROPANOL (UNII: 0F897O3O4M) ALLANTOIN (UNII: 344S277G0Z) WATERMELON (UNII: 231473QB6R) CHONDRUS CRISPUS (UNII: OQS23HUA1X) GREEN TEA LEAF (UNII: W2ZU1RY8B0) TRIBEHENIN (UNII: 8OC9U7TQZ0) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) POLYESTER-7 (UNII: 0841698D2F) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PROPANEDIOL (UNII: 5965N8W85T) SODIUM LACTATE (UNII: TU7HW0W0QT) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERYL MONOBEHENATE (UNII: A626UU0W2A) ALOE VERA LEAF (UNII: ZY81Z83H0X) MALTODEXTRIN (UNII: 7CVR7L4A2D) HYALURONATE SODIUM (UNII: YSE9PPT4TH) VITIS VINIFERA SEED (UNII: C34U15ICXA) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TOCOPHEROL (UNII: R0ZB2556P8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82657-004-01 1 in 1 CARTON 03/29/2022 1 100 mL in 1 TUBE; 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 03/01/2022 Labeler - Cay Skin, Inc. (118574309)
