Label: SABIYA BROAD SPECTRUM SPF-30- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 9, 2024

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active Ingredient

    Zinc Oxide 12.5%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn 
    • 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 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 • Zemea (Corn) Propanediol

  • Questions or Comments?

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

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SABIYA BROAD SPECTRUM SPF-30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84307-485
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION125 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)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84307-485-001 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)