AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
Vi-Jon, LLC

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Mountain Falls 711.001 711AB rev 1

Active Ingredients

Avobenzone 3%

Homosalate 13%

Octisalate 5%

Octocrylene 7%

Oxybenzone 4%

Purpose

Sunscreen

Use

  • helps prevent sunburn
  • if used as directed with other sun protections measures (see Directions), decreases the rist of skin cancer and early skin aging caused by the sun

Warnings

For external use only

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 a 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

Inactive ingredients

water, sorbitol, triethanolamine, VP/eicosene copolymer, stearic acid, sorbitan isostearate, aluminum starch octenylsuccinate, benzyl alcohol, dimethicone, tocopheryl, chlorphenesin, polyglyceryl-3 distearate, fragrance, carbomer, disodium EDTA

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Bayer, distributor of Coppertone Ultra Guard Sunscreen Lotion Broad Spectrum SPF 50.

Made in the USA with US and foreign parts.

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

Questions or Comments? 1-888-593-0593

www.mymountainfalls.com

principal display panel

mountain

falls

*Compare to Coppertone

paraben free

SPF

50

water

resistant

80

minutes

ultra

sunscreen

lotion

BROAD

SPECTRUM

SPF 50

UVA/UVB SUNSCREEN

16 FL OZ (473 mL)

mm01

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE 
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0711
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.9 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE133.9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE51.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE72.1 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE41.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
TROLAMINE (UNII: 9O3K93S3TK)  
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0711-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/12/201605/22/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02001/12/201605/22/2020
Labeler - Vi-Jon, LLC (088520668)
Registrant - Vi-Jon, LLC (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(0869-0711)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(0869-0711)

Revised: 2/2024
Document Id: 10be0b1f-1420-c5cc-e063-6394a90a29f0
Set id: 2759d420-4388-46e8-b36f-ace3278b2c6c
Version: 15
Effective Time: 20240206
 
Vi-Jon, LLC