SUN BUM PREMIUM SUNSCREEN FACE BROAD SPECTRUM SPF 30- avobenzone, homosalate, octinoxate, octisalate stick

Sun Bum Premium Sunscreen Face Broad Spectrum SPF 30 by

Drug Labeling and Warnings

Sun Bum Premium Sunscreen Face Broad Spectrum SPF 30 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

Avobenzone 2.00%, Homosalate 15.00%,

Octinoxate 7.50%, Octisalate 5.00%

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

Ascorbyl Palmitate, Beeswax, BHT, Cetyl Alcohol, Ethylhexyl Palmitate, Euphorbia Cerifera (Candelilla) Wax, Fragrance, Ozokerite, Paraffin, Polyester-8, Polyethylene, Tocopheryl Acetate.

Other Information

• Protect this product from excessive heat and direct sun.

Questions or Comments?

• Call +1 (877) 978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM PREMIUM SUNSCREEN FACE BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-207
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ASCORBYL PALMITATE (UNII: QN83US2B0N)
YELLOW WAX (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
CETYL ALCOHOL (UNII: 936JST6JCN)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CANDELILLA WAX (UNII: WL0328HX19)
PARAFFIN (UNII: I9O0E3H2ZE)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-207-01	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)