MIST ME SPF-40- zinc oxide aerosol, spray

Mist Me SPF-40 by

Drug Labeling and Warnings

Mist Me SPF-40 by is a Otc medication manufactured, distributed, or labeled by Cove Suncare LLC, Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

Non-nano Zinc Oxide 22%

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 ask doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure.
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• Sun protection measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other skin protection measures including:
  • limit time in the sun, especially from 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months: Ask a doctor.

Other information

• protect this product from excessive heat and direct sun
• may stain or damage some fabrics or surfaces

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Bentonite Bisabolol, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylhydroxamic Acid (and) Glyceryl Caprylate (and) Glycerin, Cetearyl Alcohol (and) Coco-Glucoside, Glycerin, Glycerin (and) Cucumis Sativus (Cucumber) Extract, Helianthus Annuus (Sunflower) Seed Oil , Hydrogenated Methyl Abietate, Jojoba Esters, Lauryl Glucoside (and) Myristyl Glucoside (and) Polyglyceryl-6 Laurate, Microcrystalline Cellulose (and) Cellulose Gum, Polyricinoleic Acid, Sodium Stearoyl Glutamate, Tocopherol, Water

Questions?

Call 1-877-465-2683

SPL UNCLASSIFIED SECTION

Distributed by Cove Suncare
Hayward, CA 94544

PRINCIPAL DISPLAY PANEL - 162 ml Can Label

COVE
SUNCARE

Mist Me

MINERAL-BASED SUNSCREEN

SPF
40

NO PHTHALATES | FRAGRANCE FREE
PARABEN FREE

WATER RESISTANT (80 MINUTES)

REEF
FRIENDLY

NO CHEMICAL
ACTIVES

VEGAN

DERMATOLOGIST
TESTED

5.5 fl oz (162 ml)

INGREDIENTS AND APPEARANCE

MIST ME SPF-40 
zinc oxide aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85753-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	22 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Sunflower Oil (UNII: 3W1JG795YI)
Medium-Chain Triglycerides (UNII: C9H2L21V7U)
Bentonite (UNII: A3N5ZCN45C)
Glycerin (UNII: PDC6A3C0OX)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Coco-Glucoside (UNII: ICS790225B)
Hydrogenated Methyl Abietate (UNII: A23O709X8O)
Capryloyl Glycerin/Sebacic Acid Copolymer (2000 Mpa.S) (UNII: N7YC58165T)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)
Caprylhydroxamic Acid (UNII: UPY805K99W)
Glyceryl Monocaprylate (UNII: TM2TZD4G4A)
Lauryl Glucoside (UNII: 76LN7P7UCU)
Myristyl Glucoside (UNII: 6AK28695LF)
Polyglyceryl-6 Laurate (UNII: Q48X4BL3TV)
Tocopherol (UNII: R0ZB2556P8)
Levomenol (UNII: 24WE03BX2T)
Allantoin (UNII: 344S277G0Z)
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85753-101-01	162 mL in 1 CAN; Type 0: Not a Combination Product	11/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M020	11/01/2025

Labeler - Cove Suncare LLC (137758989)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Inc.		189788201	MANUFACTURE(85753-101)