Label: BELASOL SUN CREAM NON-TINTED MOISTURIZING SPF 50- titanium dioxide, zinc oxide cream
- NDC Code(s): 83789-434-00
- Packager: EK Clothing LLC dba Belasol
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 9, 2023
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- Drug Facts
- Active Ingredients
- Uses:
- Warnings:
-
Directions:
- Apply liberally 15 minutes before sun exposure and as needed.
- Children under 6 months of age: ask a doctor.
- Reapply:
- After 40 minutes of swimming or sweating.
- Imediately 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m - 2 p.m.
- Wear long sleeved shirts, pants, hats, and sunglasses.
- Other Information:
-
Inactive Ingredients:
Aqua (Deionized Water), Butyloctyl salicylate, Camelllia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citric Acid, Caprylyl Glycol, Cocos Nucifera (Coconut) Oil, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydrogenated Methyl Abietate, Iron Oxides (Black, Red, Yellow), Isododecane, Polyhydroxystearic Acid, Polysilicone-15, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Squalane, Stearic Acid, Tetrahexyldecyl Ascorbate (Vitamin C), Trimethylsiloxysilicate, Ubiquinone (CoQ10), Xanthan Gum, Zemea (Corn) Propanediol.
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- Package Labeling:
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INGREDIENTS AND APPEARANCE
BELASOL SUN CREAM NON-TINTED MOISTURIZING SPF 50
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83789-434 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 20 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 170 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) GREEN TEA LEAF (UNII: W2ZU1RY8B0) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) CAPRYLYL GLYCOL (UNII: 00YIU5438U) COCONUT OIL (UNII: Q9L0O73W7L) DODECANE (UNII: 11A386X1QH) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL LAURATE (UNII: Y98611C087) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERYL STEARATE CITRATE (UNII: WH8T92A065) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O) FERRIC OXIDE RED (UNII: 1K09F3G675) ISODODECANE (UNII: A8289P68Y2) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POLYSILICONE-15 (UNII: F8DRP5BB29) POLYSORBATE 20 (UNII: 7T1F30V5YH) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) UBIDECARENONE (UNII: EJ27X76M46) XANTHAN GUM (UNII: TTV12P4NEE) CORN (UNII: 0N8672707O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83789-434-00 118.3 mL in 1 TUBE; Type 0: Not a Combination Product 11/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/20/2023 Labeler - EK Clothing LLC dba Belasol (105132683)
