FDA.reportPublic FDA data

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 233 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony TintTITANIUM DIOXIDE/ZINC OXIDESPF Ventures LLC2d490531-af36-87d0-e063-6394a90acf492025-02-03WarningsExact identifier
application number: M020
YOUR TINTED MOISTURIZER HYDRATING ANTI AGING BROAD SPECTRUM SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONESkin Ai, LLC2d8b7d07-2249-898b-e063-6394a90af6ad2025-02-01WarningsExact identifier
application number: M020
ESSENCE LIGHT SUNSCREEN SPF 50 PAAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEENGLEWOOD LAB, INC.f5c79f1a-cecd-2409-e053-2995a90ad06f2025-01-31WarningsExact identifier
application number: M020
RODAN - FIELDS ESSENTIALS Body Sunscreen BROAD SPECTRUM SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields67b55df8-9623-4352-b136-b0bc8d1efe022025-01-31WarningsExact identifier
application number: M020
Oil-Free Daily Hydration SPF 15OCTINOXATE, AVOBENZONEBoscia LLCec322ae5-ab03-4c7b-9c6d-0bda3327c72a2025-01-31WarningsExact identifier
application number: M020
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEPaula's Choice, Incb90658d0-e422-4265-a6ee-39c29b6c116a2025-01-31WarningsExact identifier
application number: M020
SunStation USA SPF-30 SPORT SUNSCREENZINC OXIDERENU LABORATORIES, LLC11d3c60e-238d-999e-e063-6394a90a624b2025-01-31WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
application number: M020
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Shimmer One Mineral Glow SPF 45ZINC OXIDEKao USA Inc.0c935521-4e8b-0605-e063-6394a90a0bbc2025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Invisible One Sunscreen Plus Primer SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c7ce5b9-5ab4-d845-e063-6394a90afa762025-01-31WarningsExact identifier
application number: M020
Hello Sunday The Mineral One Lightweight Serum SPF 50ZINC OXIDEKao USA Inc.0c91894f-a40e-73e9-e063-6394a90ab8072025-01-31WarningsExact identifier
application number: M020
Hello Sunday The One Thats a Serum Hydrating Serum SPF 45AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.0c913096-c000-4336-e063-6394a90a560c2025-01-31WarningsExact identifier
application number: M020
Hello Sunday Bestseller Daily SPF DuoAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKao USA Inc.26cf264b-f68d-5691-e063-6394a90a8ab42025-01-31WarningsExact identifier
application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)ZINC OXIDEFallien Cosmeceuticals, LTD2d0856cf-d3da-5a77-e063-6294a90ad5b42025-01-31WarningsExact identifier
application number: M020
FRE PROTECT BODY Ultra-Light Gel Cream SPF 50ZINC OXIDEPeer Pharm Ltd.2cd83c55-851c-089e-e063-6294a90ad6bc2025-01-30WarningsExact identifier
application number: M020
FRE BRONZE ME Sun-Kissed Mineral Sunscreen SPF 50ZINC OXIDEPeer Pharm Ltd.2cd958a3-bad6-725e-e063-6294a90a85782025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT CASSIS SPF 30ZINC OXIDEPeer Pharm Ltd.2cd77d62-77df-f3a9-e063-6394a90ad57d2025-01-30WarningsExact identifier
application number: M020
FRE PLUMP ME PEPTIDE LIP TINT PAMPELONNE SPF 30ZINC OXIDEPeer Pharm Ltd.2caf3b6b-3a05-b24a-e063-6394a90a47992025-01-30WarningsExact identifier
application number: M020
Jil Goorman Skincare Sun Guard SPF 30AVOBENZONE, OCTISALATE, OCTOCRYLENESAN DIEGO NATURAL SOAP COMPANY9a088bed-3b85-4bf5-923b-4c99eb904a8d2025-01-30WarningsExact 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