FDA.reportPublic FDA data

SABIYA Broad Spectrum SPF-50

Manufacturer
SABIYA, LLC | Pure Source, LLC
Effective date
2024-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:44

Label at a glance#

ProductSABIYA Broad Spectrum SPF-50
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

Helps prevent sunburn higher SPF gives more sunburn protection  retains SPF after 80 minutes of swimming or sweating. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Shake well prior to use  Apply liberally and evenly to dry skin 15 minutes before sun exposure  reapply after 80 minutes of swimming or sweating  immediately after towel drying at least every 2 hours.  Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • higher SPF gives more sunburn protection 
  • retains SPF after 80 minutes of swimming or sweating.
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

WARNINGS SECTION

  • For external use only.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash or irritation occurs 

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well prior to use 
  • Apply liberally and evenly to dry skin 15 minutes before sun exposure 
  • reapply after 80 minutes of swimming or sweating 
  • immediately after towel drying
  • at least every 2 hours. 
  • Sun Protection Measures. 
  • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. to 2 p.m.
  • wear long-sleeved shirts, pants, hats and sunglasses 
  • use a water-resistant sunscreen if swimming or sweating 
  • children under 6 months of age: Ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product and its container from excessive heat and direct sun. 

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice • Aqua (Deionized Water) • Butyrospermum Parkii (Shea) Butter • Caprylic/Capric Triglyceride • Caprylyl Glycol • Citric Acid • Coos Nucifera (Coconut) Oil • Decyl Glucoside • Dodecane • Fucus Vesiculosus (Seaweed) Extract • Glycerin• Glyceryl Laurate • Glyceryl Stearate • Glyceryl Undecylenate • Isododecane • Macrocystis Pyrifera (Sea Kelp) Extract • Parfum (Fragrance) • Pearl Powder • Polyhydroxystearic Acid •Saccharomyces Ferment Filtrate • Sargassum Vulgare (Algae) Extract • Sodium Stearoyl Glutamate • Sorbitan Stearate •Tapioca Starch • Tetrasodium EDTA • Tocopherol (Vitamin E) • Tridecyl Salicylate • Trimethylsiloxysilicate • Xanthan Gum • 

Questions or Comments?

OTC - QUESTIONS SECTION

Visit www.sabiya.comor call + 1 (754) 216-3334

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84307-48684307-486-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SHEA BUTTERK49155WL9YIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DODECANE11A386X1QHIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL LAURATEY98611C087IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISODODECANEA8289P68Y2IACT
PEARL (HYRIOPSIS CUMINGII)A75L5FZ40UIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
STARCH, TAPIOCA24SC3U704IIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
TRIDECYL SALICYLATEAZQ08K38Z1IACT
XANTHAN GUMTTV12P4NEEIACT
ZINC OXIDESOI2LOH54ZACTIM

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SABIYA Broad Spectrum SPF-50ZINC OXIDESABIYA, LLC4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c2024-05-09WarningsExact identifier
ndc (package): 84307-486-00
ndc (product): 84307-486
ndc11 (package): 84307048600
spl id: 18020632-3cf1-4562-e063-6294a90ab1ad
spl set id: 4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.