MIAMI MD SUN SHIELD Broad Spectrum SPF 40

Manufacturer
BRAND BOLT LLC
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:55

Label at a glance#

ProductMIAMI MD SUN SHIELD Broad Spectrum SPF 40
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and uses

Helps prevent sunburn. Higher SPF gives more sunburn protection. If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Dosage and administration

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. 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: Sun P...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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


Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses:

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection.
  • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Warnings

WARNINGS SECTION

For external use only

Do not use 

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash or irritation develops and lasts.

Keep out of reach of children. 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Other Information:

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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.
  • 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: Sun Protection Measures. 
  • Limit time in the sunm especially from 10 a.m. - 2 p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Questions?

OTC - QUESTIONS SECTION

1-844-829-8772

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label00Label00

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83140-373-00MIAMI MD SUN SHIELD Broad Spectrum SPF 4030 mL in 1 BOTTLECREAM302
83140-373-00MIAMI MD SUN SHIELD Broad Spectrum SPF 401 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83140-373MIAMI MD SUN SHIELD BROAD SPECTRUM SPF 40 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [BRAND BOLT LLC]2Current NDC, Legacy NDC, 2 package rows20231106_3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83140-37383140-373-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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
MIAMI MD SUN SHIELD Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEBRAND BOLT LLC3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd2023-11-06WarningsExact identifier
ndc (package): 83140-373-00
ndc (product): 83140-373
ndc11 (package): 83140037300
spl id: 0976e636-18dc-0818-e063-6294a90adeb8
spl set id: 3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd

Reported adverse events (FAERS/openFDA)#

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