Cay Skin Universal Mineral Face Lotion SPF 55

Cay Skin Universal Mineral Face SPF 55 by

Drug Labeling and Warnings

Cay Skin Universal Mineral Face SPF 55 by is a Otc medication manufactured, distributed, or labeled by Cay Skin, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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Cay Skin Universal Mineral Face Lotion SPF 55

Drug Facts

Active ingredients

Zinc Oxide 12%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

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:

• 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

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

CAY SKIN UNIVERSAL MINERAL FACE SPF 55 
zinc oxide lotion

Product 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)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
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)

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 Drug	M020	03/01/2022	12/01/2023

Labeler - Cay Skin, Inc. (118574309)

Revised: 12/2024

Document Id: 2889e778-60c3-16d6-e063-6394a90a02fc

34390-5

Set id: db5fea32-2595-5a33-e053-2a95a90a352b

Version: 2

Effective Time: 20241205