BELASOL SUN CREAM NON-TINTED MOISTURIZING SPF 50- titanium dioxide, zinc oxide cream 
EK Clothing LLC dba Belasol

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BELASOL Sun Cream Non-Tinted Moisturizing SPF 50

Drug Facts

Active Ingredients

Titanuium Dioxide 2.00%

Zinc Oxide 17.00%

Purpose

Sunscreen

Uses:

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 develops and lasts.

Keep out of reach of children.

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

If pregnant or breast-feeding, 

ask a health professional before use.

Directions:

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.

Questions?

(786) 361-7266

Package Labeling:

Label

BELASOL SUN CREAM NON-TINTED MOISTURIZING SPF 50 
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83789-434
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION170 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83789-434-00118.3 mL in 1 TUBE; Type 0: Not a Combination Product11/20/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/20/2023
Labeler - EK Clothing LLC dba Belasol (105132683)

Revised: 11/2023
Document Id: 09b53878-59e1-2326-e063-6294a90aa3a4
Set id: fb677ad0-2791-44ec-9720-951471ec009a
Version: 1
Effective Time: 20231109
 
EK Clothing LLC dba Belasol