mist me spf-40

mist me spf-40
SPL v1
SPL
SPL Set ID b7f09089-54a4-4f60-b632-e3f4321313ec
Route
topical
Published
Effective Date 2025-10-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (22 g)
Inactive Ingredients
water aloe vera leaf butyloctyl salicylate sunflower oil medium-chain triglycerides bentonite glycerin cetostearyl alcohol coco-glucoside hydrogenated methyl abietate capryloyl glycerin/sebacic acid copolymer (2000 mpa.s) microcrystalline cellulose carboxymethylcellulose sodium, unspecified caprylhydroxamic acid glyceryl monocaprylate lauryl glucoside myristyl glucoside polyglyceryl-6 laurate tocopherol levomenol allantoin sodium stearoyl glutamate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-11-01

Purpose

Sunscreen

Description

Drug Facts


Medication Information

Warnings

For external use only

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.
Purpose

Sunscreen

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

Description

Drug Facts

Questions?

Call 1-877-465-2683

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if rash occurs.

Section 50567-7

When using this product

  • keep out of eyes. Rinse with water to remove.
Section 50570-1

Do not use on damaged or broken skin

Active Ingredients

Non-nano Zinc Oxide 22%

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)


Structured Label Content

Warnings

For external use only

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.
Purpose

Sunscreen

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 (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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask doctor if rash occurs.

Section 50567-7 (50567-7)

When using this product

  • keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)

Do not use on damaged or broken skin

Active Ingredients

Non-nano Zinc Oxide 22%

Principal Display Panel 162 Ml Can Label (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)


Advanced Ingredient Data


Raw Label Data

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