SUN BUM SPF 30 PREMIUM MOISTURIZING SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

Sun Bum SPF 30 Premium Moisturizing Sunscreen by

Drug Labeling and Warnings

Sun Bum SPF 30 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%, Homosalate 10%, Octisalate 5%, Octocrylene 3.75%

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.

Flammable: do not use near heat, flame, or while smoking

Do not use 

on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove.
• use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful of fatal.
• do not puncture or incinerate. Contents under pressure.
• Do not store at temperatures above 120°F.

Stop use and ask a doctor if

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

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 info 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.
• children under 6 months: ask a doctor.
• 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 Broad Spectrum SPF of 15 or higher and other sun protection measures, including
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

Other Information

protect this product from excessive heat and directed sun

Inactive ingredients

alcohol denat. (67%), acrylates/octylacrylamide copolymer, C12-15 alkyl benzoate, dicaprylyl carbonate, PPG-5-ceteth-20, fragrance, tocopherol

Questions?

Call 1-877-978-6286

Package Labeling:

INGREDIENTS AND APPEARANCE

SUN BUM SPF 30 PREMIUM MOISTURIZING SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-254
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	37.5 mg  in 1 g

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: 69039-254-01	50 g in 1 BOTTLE; Type 0: Not a Combination Product	01/28/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/28/2019

Labeler - Sun Bum LLC (028642574)