FDA.reportPublic FDA data

MIRABELLA Broad Spectrum SPF 30 Sunscreen

Product NDC
83741-480
11-digit product format
837410480
Labeler code
83741
Product ID
83741-480_17c8c23c-4be5-8d00-e063-6394a90a941b
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTISALATE, AVOBENZONE
Dosage form
CREAM
Route
TOPICAL
Labeler
GDM ENTERPRISES LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-06
Substance
HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength
100; 50; 30 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
MIRABELLA Broad Spectrum SPF 30 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE100 mg/mL
OCTISALATE50 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ac847d5-a75d-4b32-84e1-70e4282c0d72Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83741-480-00MIRABELLA Broad Spectrum SPF 30 Sunscreen1 in 1 BOXCREAM11
83741-480-00MIRABELLA Broad Spectrum SPF 30 Sunscreen40 mL in 1 BOTTLE, PUMPCREAM401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83741-480MIRABELLA BROAD SPECTRUM SPF 30 SUNSCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE) CREAM [GDM ENTERPRISES LLC]1Current NDC, 2 package rows20240507_3ac847d5-a75d-4b32-84e1-70e4282c0d72.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 41 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Light MediumZINC OXIDEZO Skin Health, Inc.4fabe9d0-27fe-230f-e063-6294a90a9ac02026-04-17WarningsExact identifier
application number: M020
ZO Skin Health Sheer Fluid Tint Broad-Spectrum Sunscreen SPF 45 Medium-TanZINC OXIDEZO Skin Health, Inc.4fac82b7-d685-2a0d-e063-6394a90aa7952026-04-17WarningsExact identifier
application number: M020
SALT WATER VANILLA SUNSCREEN BODY BROAD SPECTRUM SPF 50SUNSCREENSaltair Body LLC4fae649d-f60e-0275-e063-6294a90a1ea52026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e64-2eab-1219-e063-6294a90a79a82026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cd8a3-3d62-83ac-e063-6394a90a4afa2026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e2424f4-0011-42b0-e063-6394a90a780d2026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHTYOUR NAME MINERAL SHEER TINTPML NYC, LLC316cfaea-b71f-2956-e063-6294a90a4f202026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUMYOUR NAME MINERAL SHEER TINTPML NYC, LLC316d1515-6092-a7d6-e063-6394a90ab8b22026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEPYOUR NAME MINERAL SHEER TINTPML NYC, LLC0e246e70-6ec3-5711-e063-6394a90a38792026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20YOUR NAME MINERAL SHEER TINTPML NYC, LLC0e241343-db63-3f1c-e063-6394a90ab5382026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20YOUR NAME MINERAL SHEER TINTPML NYC, LLC316df5fe-0574-d59f-e063-6294a90af8b92026-04-17WarningsExact identifier
application number: M020
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- SUN GLOWYOUR NAME MINERAL SHEER TINTPML NYC, LLC316c5d69-46f4-7677-e063-6294a90a610f2026-04-17WarningsExact identifier
application number: M020
RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20RETEXTURIZING PRIMER BROAD SPECTRUM SPF 20PML NYC, LLC316d905f-232c-d8a2-e063-6394a90adbc92026-04-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream230 NPML NYC, LLC316ea01b-4bff-55be-e063-6394a90add942026-04-17WarningsExact identifier
application number: M020
Sei Bella Tinted BB Moisturizing Cream410 NPML NYC, LLC316e97bc-4b96-ba6e-e063-6294a90a76482026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c781d7-9d48-892f-e053-2a95a90aca862026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c757b4-6c92-18f0-e053-2a95a90a246d2026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c76a82-dc87-35e7-e053-2995a90ae3102026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7ac71-3f38-52b2-e053-2a95a90ab54e2026-04-17WarningsExact identifier
application number: M020
TULA RADIANT SKIN BRIGHTENING SERUM SKIN TINT SUNSCREEN BROAD SPECTRUM SPF 30BRIGHTENING SKIN TINTPML NYC, LLCf4c7b929-7492-f072-e053-2995a90a1ca32026-04-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83741-480-00837410480001 BOTTLE, PUMP in 1 BOX (83741-480-00) / 40 mL in 1 BOTTLE, PUMP2024-05-06NoNoCurrent