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 289 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Daytime Facial Moisturizer with Broad Spectrum SPF 30 SunscreenHOMOSALATE, OCTOCRYLENE, ZINC OXIDEWALGREEN COMPANYf9c81d88-8e28-fa53-e053-6394a90ac5c42024-10-11WarningsExact identifier
application number: M020
WALGREENS 100 SHEER BROAD SPECTRUM SPF 100AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANYfa18067a-310b-bdc3-e053-6394a90aee792024-10-11WarningsExact identifier
application number: M020
Walgreens 50 Mineral Zinc Oxide SunscreenZINC OXIDEWALGREEN COMPANY24223fbf-8ce9-ec5e-e063-6294a90a29da2024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Mineral Zinc Oxide SunscreenZINC OXIDEWALGREEN COMPANY2422b327-ea83-f4c3-e063-6394a90a5c6e2024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Watermelon Scented Continuous SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24256e54-ae34-91b2-e063-6394a90a33c02024-10-10WarningsExact identifier
application number: M020
Walgreens 50 Premium Face Moisturizing SunscreenAVOBENZONE. HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24265a48-fd07-c78a-e063-6394a90ab67e2024-10-10WarningsExact identifier
application number: M020
Walgreens Broad Spectrum SPF 50 Body Oil SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY2410df0a-db52-0769-e063-6394a90a52f32024-10-09WarningsExact identifier
application number: M020
Walgreens Broad Spectrum SPF 40 Radiant Facial SunscreenAVOBENZONE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY24114416-33b9-c6ba-e063-6394a90a6f3b2024-10-09WarningsExact identifier
application number: M020
Walgreens 40 Invisible Facial Sunscreen Broad Spectrum SPF 40AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEWALGREEN COMPANY0c40a46b-b9f9-8e14-e063-6394a90a95732024-10-09WarningsExact identifier
application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION531f60c9-c89a-46bc-8460-d01b2e838e6f2024-10-08WarningsExact identifier
application number: M020
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDEAMOREPACIFIC CORPORATION60964d9f-d96c-4397-b273-6b63d18867222024-10-08WarningsExact identifier
application number: M020
IOPE AIR CUSHION Cover 21 VanillaZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDEAMOREPACIFIC CORPORATION29d6cc8d-1469-479d-a15a-e78d4e22d4a22024-10-08WarningsExact identifier
application number: M020
IOPE UV DEFENSE SUN PROTECTORHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAMOREPACIFIC CORPORATION0f2a87f7-2185-16a5-e063-6294a90a92a32024-10-08WarningsExact identifier
application number: M020
Tropical Topical Matte SPF30ZINC OXIDEAllure Labs039fba4b-720a-9199-e063-6394a90adbfb2024-10-08WarningsExact identifier
application number: M020
LANEIGE HYDRO UV DEFENSE EX BROAD SPECTRUM SPF 50OCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONEAMOREPACIFIC CORPORATION0e746836-ed84-7b33-e063-6294a90aeff32024-10-08WarningsExact identifier
application number: M020
DermacinRx Skin Moisturizing Ultra SPF 50 SunscreenAVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDEPureTek Corporation86eb06cc-d63f-4500-a52e-14ef99a565322024-10-02WarningsExact identifier
application number: M020
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a2024-10-01WarningsExact identifier
application number: M020
PROCEUTICALS PRIVATE LABEL by TiZO eye repair non-tinted mineral sunscreenZINC OXIDEFallien Cosmeceuticals, LTD231af290-99ee-e94d-e063-6394a90a0bef2024-09-27WarningsExact identifier
application number: M020
Target Up and Up SPF 70 Sport SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENETARGET CORPORATION23085ab9-5abb-a572-e063-6394a90ae34a2024-09-26WarningsExact identifier
application number: M020
Target Up and Up Morning Facial Moisturizing with SPF 30 Sunscreen and CeramidesHOMOSALATE, OCTOCRYLENE, ZINC OXIDETARGET CORPORATION23598ad1-12a3-fe65-e063-6394a90a4f6f2024-09-26WarningsExact 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