Sunscreen (Avobenzone, Homosalate, Octisalate, Oxybenzone) Spray [Vi-Jon] -

SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE) SPRAY [VI-JON]
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NDC	0869-0730-18, 0869-0730-30, 0869-0730-38
Set ID	14775e7f-a4dc-4dc2-94af-d9c8f0922012
Category	HUMAN OTC DRUG LABEL
Packager	Vi-Jon, LLC
Generic Name
Product Class
Product Number
Application Number	PART352

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Active ingredients

Avobenzone 2%

Homosalate 15%

Octisalate 5%

Oxybenzone 4%
Purpose

Sunscreen
Use
- 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
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 Right away
Directions
- 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 Broad Spectrum SPF value 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
- children under 6 months of age: Ask a doctor
Other information
- protect the product from excessive heat and direct sun
- avoid long term storage above 40°C (104°F)
Inactive ingredients

alcohol denat., acrylates/octylacrylamide copolymer, glycerin, fragrance
SPL UNCLASSIFIED SECTION

May stain or damage some fabrics or surfaces

This product is not manufactured or distributed by Bayer, distributor of Coppertone Sport High Performance Sunscreen Continuous Spray UVA/UVB Broad Spectrum SPF 30.

Made in the USA with US and foreign parts.

Manufactured by: Vi-Jon, Inc., St. Louis, MO 63114

Questions or Comments? 1-888-593-0593

www.mymountainfalls.com
principal display panel

Continuous Spray

mountain falls

Compare to Coppertone*

paraben free

water resistant

80 minutes

SPF 30

sweat resistant

sport sunscreen spray

BROAD SPECTRUM

SPF 30

UVA/UVB

sunscreen

NET WT 2.5 FL OZ (71 g)

INGREDIENTS AND APPEARANCE

SUNSCREEN
avobenzone, homosalate, octisalate, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0869-0730
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	20 mg in 1 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	150 mg in 1 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	50 mg in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0869-0730-30	170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/07/2017
2	NDC:0869-0730-38	283 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/07/2017
3	NDC:0869-0730-18	71 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/07/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/07/2017

Labeler - Vi-Jon, LLC (790752542)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(0869-0730)

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Medic

SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE) SPRAY [VI-JON]

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