Sunscreen SPF 30 by Sun Bum / Product Quest Mfg Sunscreen SPF 30

Drug Details [pdf]

SUNSCREEN SPF 30 SUN BUM- avobenzone 3.0% homosalate 6.0% octisalate 5.0% octocrylene 2.0% 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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Sunscreen SPF 30

Active ingredients Purpose

Avobenzone 2.0%, Homosalate 5.0%, Octisalate 2.0%, Octocrylene 10.0% Sunscreen

Uses helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the rick of skin cancer and early skin aging caused by the 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 in the presence of a flame or spark. Keep away from source of ignition. No smocking. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
When using this product: Keep away from face to avoid breathing it.
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 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
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 a.m. – 2 p.m.
wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive ingredients

Acrylates/Octylacrylamide Copolymer
Alcohol Denat.
C12-15 Alkyl Benzoate
Fragrance
PPG-5-Ceteth-20
Tocopherol

Package Labeling

Front

Back

SUNSCREEN SPF 30 SUN BUM
avobenzone 3.0% homosalate 6.0% octisalate 5.0% octocrylene 2.0% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-563
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	6 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g in 100 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 69039-563-06	177 mL in 1 CAN; Type 0: Not a Combination Product	03/15/2017	08/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/15/2017	08/31/2018

Labeler - Sun Bum (028642574)

Revised: 2/2020

Document Id: 9f925356-66b9-1fea-e053-2a95a90a0033

Set id: a4484d37-d06f-430e-9605-32d564e03bd8

Version: 2

Effective Time: 20200227

Sun Bum