Label: CAY SKIN UNIVERSAL MINERAL FACE SPF 55- zinc oxide lotion
- NDC Code(s): 82657-005-01
- 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
- 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, Caprylic/Capric Triglyceride, Isoamyl Laurate, Squalane, Butyloctyl Salicylate, Glycerin, Caprylyl Glycol, Cyclodextrin, Jojoba Esters, Cetyl Alcohol, Glyceryl Stearate, Silica, Polyglyceryl-2 Dipolyhydroxystearate, PEG-75 Stearate, Methylpropanediol, Pyrus Malus (Apple) Fruit Extract, Allantoin, Rutin, Lysolecithin, Sclerotium Gum, Lecithin, Ceteth-20, Phenylpropanol, Steareth-20, Pullulan, Xanthan Gum, Citrullus Lanatus (Watermelon) Fruit Extract, Bisabolol, Iron Oxides, Lens Esculenta (Lentil) Fruit Extract, C12-15 Alkyl Benzoate, Aloe Barbadensis Leaf Juice Powder, Maltodextrin, Tetrasodium Glutamate Diacetate, Sodium Lactate, Phenoxyethanol, Chondrus Crispus Extract, Sodium PCA, Potassium Sorbate, Sodium Benzoate, Ethylhexylglycerin, Hexylene Glycol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate, Hydrogenated Lecithin, Tocopherol, Sodium Hydroxide
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- Product Packaging
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INGREDIENTS AND APPEARANCE
CAY SKIN UNIVERSAL MINERAL FACE SPF 55
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82657-005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 120 mg in 1 mL Inactive Ingredients Ingredient Name Strength ISOAMYL LAURATE (UNII: M1SLX00M3M) LEVOMENOL (UNII: 24WE03BX2T) RUTIN (UNII: 5G06TVY3R7) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) SQUALANE (UNII: GW89575KF9) CYCLODEXTRINS (UNII: 7E6SK9QDT8) STEARETH-20 (UNII: L0Q8IK9E08) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL) CETYL ALCOHOL (UNII: 936JST6JCN) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12) GLYCERIN (UNII: PDC6A3C0OX) LENTIL (UNII: 6O38V6B52O) APPLE (UNII: B423VGH5S9) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) PHENYLPROPANOL (UNII: 0F897O3O4M) ALLANTOIN (UNII: 344S277G0Z) WATERMELON (UNII: 231473QB6R) CHONDRUS CRISPUS (UNII: OQS23HUA1X) PHENOXYETHANOL (UNII: HIE492ZZ3T) LECITHIN, SUNFLOWER (UNII: 834K0WOS5G) WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) SODIUM LACTATE (UNII: TU7HW0W0QT) SODIUM BENZOATE (UNII: OJ245FE5EU) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ALOE VERA LEAF (UNII: ZY81Z83H0X) MALTODEXTRIN (UNII: 7CVR7L4A2D) HYALURONATE SODIUM (UNII: YSE9PPT4TH) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TOCOPHEROL (UNII: R0ZB2556P8) METHYLPROPANEDIOL (UNII: N8F53B3R4R) CETETH-20 (UNII: I835H2IHHX) PULLULAN (UNII: 8ZQ0AYU1TT) XANTHAN GUM (UNII: TTV12P4NEE) LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z) TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y) PEG-75 STEARATE (UNII: OT38R0N74H) BETASIZOFIRAN (UNII: 2X51AD1X3T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82657-005-01 1 in 1 CARTON 03/29/2022 1 50 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)
