Home NDC 83140-373 MIAMI MD SUN SHIELD Broad Spectrum SPF 40
Product NDC 83140-373
11-digit product format 831400373
Labeler code 83140
Product ID 83140-373_0976e636-18dc-0818-e063-6294a90adeb8
Type HUMAN OTC DRUG
Nonproprietary name AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Dosage form CREAM
Route TOPICAL
Labeler BRAND BOLT LLC
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-12-05
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30; 90; 50; 60 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base MIAMI MD SUN SHIELD Broad Spectrum SPF 40
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 90 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 60 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83140-373-00 MIAMI MD SUN SHIELD Broad Spectrum SPF 40 30 mL in 1 BOTTLE CREAM 30 2 83140-373-00 MIAMI MD SUN SHIELD Broad Spectrum SPF 40 1 in 1 CARTON CREAM 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83140-373 MIAMI MD SUN SHIELD BROAD SPECTRUM SPF 40 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) CREAM [BRAND BOLT LLC] 2 Current NDC, Legacy NDC, 2 package rows 20231106_3a53d53a-129a-41c3-a8e7-c1b1bb98d8bd.zip
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 26 of 357 · 7,139 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83140-373-00 83140037300 1 BOTTLE in 1 CARTON (83140-373-00) / 30 mL in 1 BOTTLE 1 bottle 2022-12-05 0000-00-00 No No Current