SUN BUM SPF 50 PREMIUM MOISTURIZING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

Sun Bum SPF 50 Premium Moisturizing Sunscreen by

Drug Labeling and Warnings

Sun Bum SPF 50 Premium Moisturizing Sunscreen 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 3.00%, Homosalate 15.00%,

Octisalate 5.00%, Octocrylene 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

Flammable: Contents under pressure. Do not puncture or inciinerate. Do not store at temperatures above 120°F. Do  not use in the presence of a flame or spark keep away from sources of ignition - No smoking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Do not use 

on damaged or broken skin.

When using this product:

Keep away from face to avoid breathing it. 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

• Hold container 4 to 6 inches from the skin to apply.
• Spray liberally and spread evenly by hand 15 minutes before sun exposure.
• Do not spray directly into face. Spray on hands then apply to face.
• Do not apply in windy conditions. Use in well-ventilated area.
• 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.

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Alcohol Denat.(67%), C12-15 Alkyl Benzoate, Acrylates/Octylacrylamide Copolymer, Dicaprylyl Carbonate, PPG-5-Ceteth-20, Fragrance, Tocopherol

Questions or Comments?

Call +1 (877) 978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM SPF 50 PREMIUM MOISTURIZING SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-226
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	70 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-226-01	177 mL in 1 CAN; Type 0: Not a Combination Product	08/26/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/26/2017

Labeler - Sun Bum, LLC (028642574)