Miami Md Sun Shield Broad Spectrum Spf 40 Cream
FDA Label NDC 83140-373

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Brand Bolt Llc for the product Miami Md Sun Shield Broad Spectrum Spf 40 (NDC 83140-373). 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 active ingredients, purpose, uses:, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Avobenzone 3.00%
Homosalate 9.00%
Octisalate 5.00%
Octocrylene 6.00%

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • 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 A Doctor If

rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Other Information:

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients:

Aqua (Deionized Water), Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Glyceryl Stearate Citrate, Caprylic/Capric Triglyceride, Zemea (Corn) Propanediol, Polysorbate-20, Cetearyl Alcohol, Cetearyl Glucoside, Cyclopentasiloxane, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Phenoxyethanol, Ethylhexylglycerin, Ascorbyl Palmitate (Vitamin C), Rosa Damascena (Rose) Extract, Musa Sapientum (Banana) Extract, Cocos Nucifera (Coconut) Oil, Sodium Hyaluronate, Glycyrrhiza Glabra (Licorice) Extract, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate (Vitamin C), Actinidia Chinensis (Kiwi) Extract, Niacinamide, Citric Acid, Glycerin, Jasminum Officinale (Jasmine) Extract, Tocopheryl Acetate (Vitamin E), Magnesium Aluminum Silicate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Astaxanthin.

Directions

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours.
  • Use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
  • Limit time in the sunm especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Questions?

1-844-829-8772

Package Labeling:

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