SPF 50 SIGNATURE HIGH PERFORMANCE SUNSCREEN TINTED FACE- octinoxate, titanium dioxide stick 
Sun Bum, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SPF 50 Signature High Performance Sunscreen Tinted Face Stick

Drug Facts

Active Ingredients

Octinoxate 3.00%, Titanium Dioxide 22.85%

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 occurs.

Keep out of reach of children .

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

Directions

  • Apply liberally 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 of 15 or higher and other sun protection measures, including:
  • Limit time in the sun, especially from 10 am - 2 pm.
  • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Children under 6 months: Ask a doctor.

Inactive Ingredients

Aluminum Hydroxide, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Methicone, CI. 77491 (Iron Oxide), CI 77492 (Iron Oxide), CI 77499 (Iron Oxide), Copernicia Cerifera (Carnauba) Wax, Dimethicone, Ethylhexylglycerin, Hydrogenated Polydecene, Isononyl Isononanoate, Isopropyl Myristate, Isopropyl Titanium Triisostearate, Isostearic Acid, Kaolin, Methyl Methacrylate Crosspolymer, Microcrystalline Wax, Phenoxyethanol, Phytosteryl/Behenyl/Octyldodecyl Lauroyl Glutamate, Polyethylene, Polyhydroxystearic Acid, Propylene Carbonate, Stearalkonium Hectorite, Tocopherol.

Other Information

  • Protect this product from excessive heat and direct sun.

Questions or Comments?

Call +1 (877) 9 sun Bum.

Package Labeling:

Outer PackageInner Package

SPF 50 SIGNATURE HIGH PERFORMANCE SUNSCREEN TINTED FACE 
octinoxate, titanium dioxide stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69039-210
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE30 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE228.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
KAOLIN (UNII: 24H4NWX5CO)  
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
TOCOPHEROL (UNII: R0ZB2556P8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69039-210-011 in 1 BOX08/24/201701/01/2021
113 g in 1 DIALPACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/24/201701/01/2021
Labeler - Sun Bum, LLC (028642574)

Revised: 2/2022
 
Sun Bum, LLC