CAY SKIN UNIVERSAL MINERAL BODY 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 Body Lotion SPF 55

Drug Facts

Active ingredients

Zinc Oxide 10%

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, 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

Questions or comments?

cayskin.com (256) 396-8268

Product Packaging

universal body

CAY SKIN UNIVERSAL MINERAL BODY SPF 55 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82657-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82657-004-011 in 1 CARTON03/29/2022
1100 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: d929a719-5377-0c59-e053-2995a90aeec6
Set id: d929a719-5376-0c59-e053-2995a90aeec6
Version: 1
Effective Time: 20220301
 
Cay Skin, Inc.