SABIYA BROAD SPECTRUM SPF-50- zinc oxide cream 
SABIYA, LLC

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SABIYA Broad Spectrum SPF-50

Drug Facts

Active Ingredient

Zinc Oxide 18%

Purpose

Sunscreen

Uses

Warnings

Do not use

  • on damaged or broken skin.

When using this product

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

Stop use and ask a doctor if

  • rash or irritation occurs 

Keep out of reach of children.

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

Directions

Other Information

Inactive Ingredients

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?

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

Package Labeling:

Label2

SABIYA BROAD SPECTRUM SPF-50 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84307-486
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION180 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
WATER (UNII: 059QF0KO0R)  
SHEA BUTTER (UNII: K49155WL9Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
COCONUT OIL (UNII: Q9L0O73W7L)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
DODECANE (UNII: 11A386X1QH)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL LAURATE (UNII: Y98611C087)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISODODECANE (UNII: A8289P68Y2)  
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
EDETATE SODIUM (UNII: MP1J8420LU)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:84307-486-001 in 1 BOX05/20/2024
1100 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02005/20/2024
Labeler - SABIYA, LLC (129717725)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(84307-486)

Revised: 5/2024
Document Id: 18020632-3cf1-4562-e063-6294a90ab1ad
Set id: 4264f23f-4f2a-4fd1-ad35-e7d649ee3f5c
Version: 1
Effective Time: 20240509
 
SABIYA, LLC