Mist Me Spf-40 Aerosol, Spray
FDA Label NDC 85753-101

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cove Suncare Llc for the product Mist Me Spf-40 (NDC 85753-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by Cove Suncare
Hayward, CA 94544

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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product

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

Otc - Stop Use

Stop use and ask doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

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

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)

Principal Display Panel (162 ml Can Label)

Principal Display Panel (162 ml Can Label)

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