SABIYA Broad Spectrum SPF-30

Product NDC
84307-485
11-digit product format
843070485
Labeler code
84307
Product ID
84307-485_1802047b-a1f2-c4ac-e063-6294a90a36d7
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
125 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

Additional Listing Data#

Finished product
Yes
Brand name base
SABIYA Broad Spectrum SPF-30
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ZINC OXIDE125 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiSOI2LOH54Z

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
84307-485-00SABIYA Broad Spectrum SPF-30100 mL in 1 TUBECREAM1001
84307-485-00SABIYA Broad Spectrum SPF-301 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84307-485SABIYA BROAD SPECTRUM SPF-30 (ZINC OXIDE) CREAM [SABIYA, LLC]1Current NDC, 2 package rows20240520_bc403672-7576-49a6-9a29-4f6cb19af7a4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84307-485-00843070485001 TUBE in 1 BOX (84307-485-00) / 100 mL in 1 TUBE1 tube2024-05-20NoNoCurrent