CAY SKIN UNIVERSAL MINERAL FACE SPF 55- zinc oxide lotion 
Cay Skin, Inc.

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.

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Cay Skin Universal Mineral Face Lotion SPF 55

Drug Facts

Active ingredients

Zinc Oxide 12%

Uses

Warnings

For external use only.

Do not use

on damaged or broken skin.

When using this product

keep out of eyes. Rinse with water to remove.

Stop use and consult a doctor

if skin rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 6 months of age:

Other information

Protect this product from excessive heat and direct sun.

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

Questions or comments?

cayskin.com (256) 396-8268

Product Packaging

universal face

CAY SKIN UNIVERSAL MINERAL FACE SPF 55 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE120 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82657-005-011 in 1 CARTON03/29/2022
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2022
Labeler - Cay Skin, Inc. (118574309)

Revised: 3/2022
Document Id: db5fc83c-ed39-8dd7-e053-2a95a90a3ae2
Set id: db5fea32-2595-5a33-e053-2a95a90a352b
Version: 1
Effective Time: 20220329
 
Cay Skin, Inc.