Sunscreen SPF 50

Drug Labeling and Warnings

Drug Details [pdf]

SUNSCREEN SPF 50  SUN BUM- avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 7.00% 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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Sunscreen SPF 50

Active ingredients                                                                                            Purpose

Avobenzone - 3.00%
Homosalate - 15.00%
Octisalate - 5.00%
Octocrylene - 7.00%                                                                                           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
Dicaprylyl Carbonate
Fragrance
PPG-5-Ceteth-20
Tocopherol

Package Labeling

SUNSCREEN SPF 50   SUN BUM
avobenzone 3.00% homosalate 15.00% octisalate 5.00% octocrylene 7.00% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69039-567
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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	7 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69039-567-05	177 mL in 1 CAN; Type 0: Not a Combination Product	12/15/2016	08/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/15/2016	08/31/2018

Labeler - Sun Bum (028642574)

Revised: 2/2020

Document Id: 9f9331af-aaa3-403c-e053-2a95a90a887a

34390-5

Set id: 9f1c8c35-952c-49d4-b262-747a029d24af

Version: 2

Effective Time: 20200227