SABIYA BROAD SPECTRUM SPF-50- zinc oxide cream

SABIYA Broad Spectrum SPF-50 by

Drug Labeling and Warnings

SABIYA Broad Spectrum SPF-50 by is a Otc medication manufactured, distributed, or labeled by SABIYA, LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 18%

Purpose

Sunscreen

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.

Warnings

• For external use only.

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

• 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

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

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:

INGREDIENTS AND APPEARANCE

SABIYA BROAD SPECTRUM SPF-50 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84307-486
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	180 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84307-486-00	1 in 1 BOX	05/20/2024
1		100 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/20/2024

Labeler - SABIYA, LLC (129717725)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(84307-486)