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 177 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AESOP Avail Body Sunscreen Broad Spectrum SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEEmeis Cosmetics Pty Ltd2cb40521-94ed-4e76-a4e2-de1c80155bd22025-10-17WarningsExact identifier
application number: M020
AESOP Avail Facial Sunscreen Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEEmeis Cosmetics Pty Ltdbff60c2f-0cc6-493b-81a0-ed35e97461462025-10-17WarningsExact identifier
application number: M020
Mineral Lip Balm PineappleZINC OXIDESynchronicity Spa, Inc. DBA Suntegrity667714f6-38bc-4c94-aacc-24b46e8e59fd2025-10-17WarningsExact identifier
application number: M020
ELEVEN BY VENUS WILLIAMS GAME SET MATCH BODYZINC OXIDEEco-Chic LLCdd2fe82e-31e1-1349-e053-2995a90aa4092025-10-16WarningsExact identifier
application number: M020
Hello Bello Kids SPF 50 Face and Body Sunscreen StickZINC OXIDEHello Bello4127e49a-eb27-e8e2-e063-6294a90a469e2025-10-16WarningsExact identifier
application number: M020
ELEVEN UNRIVALED SERUMZINC OXIDEEco Chic, LLCf4bdacb9-bedd-c9cc-e053-2995a90a57862025-10-16WarningsExact identifier
application number: M020
ELEVEN BY VENUS WILLIAMS ACE THE DAY FaceZINC OXIDEEco-Chic LLCde438665-72d9-9b1b-e053-2a95a90ab9ef2025-10-16WarningsExact identifier
application number: M020
Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLC6bb07f16-c3a3-49e7-ae13-718bb00558732025-10-16WarningsExact identifier
application number: M020
Illuminizing Blendrops Broad Spectrum SPF 40HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC124e6702-97a4-95bf-e063-6394a90afc0d2025-10-16WarningsExact identifier
application number: M020
Perfecting Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC414c1186-6f68-3828-e063-6294a90a66cf2025-10-16WarningsExact identifier
application number: M020
Bronzing Blendrops Broad Spectrum SPF 46HOMOSALATE, OCTISALATE, ZINC OXIDEWasatch Product Development, LLC414c2db8-3122-60d3-e063-6394a90ae1c82025-10-16WarningsExact identifier
application number: M020
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
application number: M020
Ciele Bronze and ProtectZINC OXIDECiele LLC22003cbf-5a6d-001b-e063-6394a90aefdd2025-10-15WarningsExact identifier
application number: M020
Ciele Blush and ProtectZINC OXIDECiele0162c891-ba2d-a78f-e063-6394a90a156c2025-10-15WarningsExact identifier
application number: M020
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
application number: M020
Ciele Sculpt and ProtectZINC OXIDECiele LLC21ff7f78-b543-0bea-e063-6294a90aed702025-10-15WarningsExact identifier
application number: M020
LATHER- DAILY DEFENSE MINERAL SPF 50 BODY SUNSCREENZINC OXIDELather, Inc.3158a2d7-0db5-f5bf-e063-6294a90a31262025-10-15WarningsExact identifier
application number: M020
LATHER- DAILY DEFENSE MINERAL SPF 50ZINC OXIDELather, Inc.81cf57b0-6072-432f-b421-7d1a708da1c42025-10-15WarningsExact identifier
application number: M020
Ciele Glow and ProtectZINC OXIDECiele Cosmetics27310d47-de1b-2149-e063-6394a90abe832025-10-15WarningsExact identifier
application number: M020
Sunforgettable Total Protection Sport StickZINC OXIDEColorescienced3c0d2b0-f411-565d-e053-2a95a90a081b2025-10-15WarningsExact 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