Cay Skin Universal Mineral Body Lotion SPF 55

Cay Skin Universal Mineral Body SPF 55 by

Drug Labeling and Warnings

Cay Skin Universal Mineral Body 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 BODY SPF 55- zinc oxide lotion 
Cay Skin, Inc.

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Cay Skin Universal Mineral Body Lotion SPF 55

Drug Facts

Active ingredients

Zinc Oxide 10%

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 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

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

CAY SKIN UNIVERSAL MINERAL BODY SPF 55 
zinc oxide lotion

Product 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)
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE (UNII: 687U3PEB2Y)
SQUALANE (UNII: GW89575KF9)
CYCLODEXTRINS (UNII: 7E6SK9QDT8)
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
JOJOBA OIL (UNII: 724GKU717M)
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
COCO-CAPRYLATE (UNII: 4828G836N6)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
ALLANTOIN (UNII: 344S277G0Z)
LENTIL (UNII: 6O38V6B52O)
APPLE (UNII: B423VGH5S9)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PHENYLPROPANOL (UNII: 0F897O3O4M)
WATERMELON (UNII: 231473QB6R)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
POLYESTER-7 (UNII: 0841698D2F)
TRIBEHENIN (UNII: 8OC9U7TQZ0)
LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PROPANEDIOL (UNII: 5965N8W85T)
SODIUM LACTATE (UNII: TU7HW0W0QT)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
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 Drug	M020	03/01/2022	12/01/2023

Labeler - Cay Skin, Inc. (118574309)

Revised: 12/2024

Document Id: 2889e778-60c4-16d6-e063-6394a90a02fc

34390-5

Set id: d929a719-5376-0c59-e053-2995a90aeec6

Version: 2

Effective Time: 20241205