Label: SABIYA BROAD SPECTRUM SPF-50- zinc oxide cream
- NDC Code(s): 84307-486-00
- Packager: SABIYA, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 9, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses
- Warnings
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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
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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 •
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INGREDIENTS AND APPEARANCE
SABIYA BROAD SPECTRUM SPF-50
zinc oxide creamProduct 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)