FDA.reportPublic FDA data

Mist Me SPF-40

Manufacturer
Cove Suncare LLC | Sun Deep Inc.
Effective date
2025-10-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:42:25

Label at a glance#

ProductMist Me SPF-40
Active ingredientZinc Oxide
Label structure11 sections

Indications and 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.

Dosage and administration

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 th...

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Non-nano Zinc Oxide 22%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

Call 1-877-465-2683

SPL UNCLASSIFIED SECTION

Distributed by Cove Suncare
Hayward, CA 94544

PRINCIPAL DISPLAY PANEL - 162 ml Can Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

Principal Display Panel - 162 ml Can Label
Principal Display Panel - 162 ml Can Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85753-101-01Mist Me SPF-40162 mL in 1 CANAEROSOL, SPRAY1621

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85753-10185753-101-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
Zinc OxideSOI2LOH54ZACTIB
WATER059QF0KO0RIACT
Aloe Vera LeafZY81Z83H0XIACT
Butyloctyl Salicylate2EH13UN8D3IACT
Sunflower Oil3W1JG795YIIACT
Medium-Chain TriglyceridesC9H2L21V7UIACT
BentoniteA3N5ZCN45CIACT
GlycerinPDC6A3C0OXIACT
Cetostearyl Alcohol2DMT128M1SIACT
Coco-GlucosideICS790225BIACT
Hydrogenated Methyl AbietateA23O709X8OIACT
Capryloyl Glycerin/Sebacic Acid Copolymer (2000 Mpa.S)N7YC58165TIACT
Microcrystalline CelluloseOP1R32D61UIACT
Carboxymethylcellulose Sodium, UnspecifiedK679OBS311IACT
Caprylhydroxamic AcidUPY805K99WIACT
Glyceryl MonocaprylateTM2TZD4G4AIACT
Lauryl Glucoside76LN7P7UCUIACT
Myristyl Glucoside6AK28695LFIACT
Polyglyceryl-6 LaurateQ48X4BL3TVIACT
TocopherolR0ZB2556P8IACT
Levomenol24WE03BX2TIACT
Allantoin344S277G0ZIACT
Sodium Stearoyl Glutamate65A9F4P024IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mist Me SPF-40ZINC OXIDECove Suncare LLCb7f09089-54a4-4f60-b632-e3f4321313ec2025-10-09WarningsExact identifier
ndc (package): 85753-101-01
ndc (product): 85753-101
ndc11 (package): 85753010101
spl id: cf09d70c-cebe-4c99-a2a5-a822e09d2500
spl set id: b7f09089-54a4-4f60-b632-e3f4321313ec

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.