SPF 30 SIGNATURE HIGH PERFORMANCE SUNSCREEN CLEAR FACE- homosalate, octinoxate, octocrylene, titanium dioxide, zinc oxide stick

SPF 30 Signature High Performance Sunscreen Clear Face by

Drug Labeling and Warnings

SPF 30 Signature High Performance Sunscreen Clear 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

Homosalate 7.00%, Octinoxate 7.50%,

Octocrylene 7.50%, Titanium Dioxide 4.00%

Zinc Oxide 7.00%

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

Adipic Acid/Diglycol Crosspolymer, Alumina, Beeswax, Ceteareth-20, Cetearyl Alcohol, Dimethicone, Ethylhexyl Palmitate, Methicone, Ozokerite, Paraffin, Tocopherol, Trimethoxycaprylylsilane, VP/Eicosene Copolymer.

Other Information

• Protect this product from excessive heat and direct sun.

Questions or Comments?

• Call +1 (877) 9 Sun Bum.

Package Labeling:

Exterior Carton Labeling:

Tube Labeling:

INGREDIENTS AND APPEARANCE

SPF 30 SIGNATURE HIGH PERFORMANCE SUNSCREEN CLEAR FACE 
homosalate, octinoxate, octocrylene, titanium dioxide, zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-206
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	70 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	75 mg  in 1 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	70 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM OXIDE (UNII: LMI26O6933)
YELLOW WAX (UNII: 2ZA36H0S2V)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PARAFFIN (UNII: I9O0E3H2ZE)
TOCOPHEROL (UNII: R0ZB2556P8)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-206-01	1 in 1 CARTON	04/26/2016
1		13 g 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 not final	part352	04/26/2016

Labeler - Sun bum LLC (028642574)