SunBum SPF 50 by Sun Bum / Product Quest Mfg. SunBum SPF 50

Drug Details [pdf]

SUNBUM SPF 50- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.75% oxybenzone 6.00% spray
Sun Bum

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SunBum SPF 50

Active ingredients Purpose

Avobenzone 3.00% Sunscreen
Homosalate 15.00%
Octisalate 5.00%
Octocrylene 2.75%
Oxybenzone 6.00%

Uses

- helps prevent sunburn
- if used as directed with other sun protection messures ( see Directions) decreases the risk of skin cancer and early skin aging caused by sun.

Warnings
For external use only

Flammable: Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. Do not use at 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 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 4-6 inches from skin to apply.
Spray liberally and spread evenly by hands 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 a.m. – 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive ingredients

Acrylates/Dimethicone Copolymer
Acrylates/Octylacrylamide Copolymer
Alcohol Denat.
Ascorbyl Palmitate
Cyclopentasiloxane
Dimethicone
Fragrance
Polyester-8
PPG-5-Ceteth-20
Tocopheryl Acetate
Trisiloxane

Package Labeling

Front

Back

SUNBUM SPF 50
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 2.75% oxybenzone 6.00% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-560
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
TRISILOXANE (UNII: 9G1ZW13R0G)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69039-560-05	177 mL in 1 CAN; Type 0: Not a Combination Product	02/10/2011	08/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/10/2011	08/31/2018

Labeler - Sun Bum (028642574)

Revised: 2/2020

Document Id: 9f922468-4b36-bcfd-e053-2995a90a4e78

Set id: d6e356de-8987-4be9-8890-8f4952f7dc74

Version: 2

Effective Time: 20200227