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

SPF 50 Signature High Performance Sunscreen Tinted Face by

Drug Labeling and Warnings

SPF 50 Signature High Performance Sunscreen Tinted Face by is a Otc medication manufactured, distributed, or labeled by Sun Bum, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

SPF 50 SIGNATURE HIGH PERFORMANCE SUNSCREEN TINTED FACE 
octinoxate, titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-210
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	30 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	228.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-210-01	1 in 1 BOX	08/24/2017
1		13 g in 1 DIALPACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/24/2017

Labeler - Sun Bum, LLC (028642574)