SABIYA Broad Spectrum SPF-50

Product NDC
84307-486
11-digit product format
843070486
Labeler code
84307
Product ID
84307-486_18020632-3cf1-4562-e063-6294a90ab1ad
Type
HUMAN OTC DRUG
Nonproprietary name
ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
SABIYA, LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-20
Substance
ZINC OXIDE
Active strength
180 mg/mL
Pharmacologic classes
Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
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
SABIYA Broad Spectrum SPF-50
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE180 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4264f23f-4f2a-4fd1-ad35-e7d649ee3f5cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84307-486-00SABIYA Broad Spectrum SPF-50100 mL in 1 TUBECREAM1001
84307-486-00SABIYA Broad Spectrum SPF-501 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84307-486SABIYA BROAD SPECTRUM SPF-50 (ZINC OXIDE) CREAM [SABIYA, LLC]1Current NDC, 2 package rows20240520_4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c.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 196 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Bum Daily Sunscreen Mist Broad Spectrum SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a796a0b-8021-9a9f-e063-6294a90a6eb22025-08-15WarningsExact identifier
application number: M020
SOLARA SUNCARE - DAY DREAMER SPF 30ZINC OXIDESOLARA SUNCARE, INC.3c6c9266-a7ff-19f4-e063-6294a90a60962025-08-15WarningsExact identifier
application number: M020
Sun Bum Mineral 30 Sheer Sunscreen FaceZINC OXIDESun Bum, LLC3b00c2d6-a55d-0a56-e063-6294a90ac4b82025-08-15WarningsExact identifier
application number: M020
Sun Bum Mineral 30 Sunscreen 3 OZZINC OXIDESun Bum, LLC3b014bd6-ba40-9003-e063-6394a90ab4512025-08-15WarningsExact identifier
application number: M020
Ocean Potion Suncare Mineral 30 Zinc Oxide SunscreenZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3c6e7e62-4313-cbce-e063-6394a90ac3822025-08-15WarningsExact identifier
application number: M020
Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 SunscreenOCTOCRYLENE, ZINC OXIDEGNL BRANDS INTERNATIONAL, LLC3c6f3e0b-2dff-6dc3-e063-6394a90abb0e2025-08-15WarningsExact identifier
application number: M020
EltaMD UV Daily HydrationOCTISALATE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc.bfdb266b-9920-4225-84c7-bcbad81fd1c72025-08-15WarningsExact identifier
application number: M020
Sun Bum 70 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC39fb5e66-5172-3b83-e063-6394a90aab2d2025-08-14WarningsExact identifier
application number: M020
Sun Bum Face Cream 50 Premium SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3c57fcf7-7816-8197-e063-6394a90af80a2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen Roll-OnAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c58c9c7-ca9e-d012-e063-6394a90a5aa92025-08-14WarningsExact identifier
application number: M020
Sun Bum 30 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a003d82-90bd-f541-e063-6394a90ac9062025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a00e4fb-6bf2-4c44-e063-6294a90a61bf2025-08-14WarningsExact identifier
application number: M020
Sun Bum 15 Premium Moisturizing Sunscreen 8 OZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a0f99df-e6c0-71d9-e063-6294a90a4c9e2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Mineral SunscreenZINC OXIDESun Bum, LLC3a13d4f1-c158-7fa0-e063-6294a90a6fb42025-08-14WarningsExact identifier
application number: M020
Sun Bum Kids 50 Clear Sunscreen Face StickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3a147fe1-0dda-5433-e063-6394a90a1a592025-08-14WarningsExact identifier
application number: M020
Sun Bum 15 Premium Sunscreen BrowningAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3c5b0db8-f05a-2b5c-e063-6294a90ae79b2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Premium Moisturizing SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENESun Bum, LLC3aaf7d28-b306-b416-e063-6294a90a021e2025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a263b85-e7a0-c068-e063-6294a90a49f22025-08-14WarningsExact identifier
application number: M020
Sun Bum 50 Mineral Sunscreen Roll-OnTITANIUM DIOXIDE, ZINC OXIDESun Bum, LLC3a392237-019d-2384-e063-6394a90a5b242025-08-14WarningsExact identifier
application number: M020
Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - BonfireHOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDESun Bum, LLC3a3b3b4a-148c-1dc5-e063-6394a90a7bdb2025-08-14WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84307-486-00843070486001 TUBE in 1 BOX (84307-486-00) / 100 mL in 1 TUBE1 tube2024-05-20NoNoCurrent