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

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Mountain Falls 714.000 714AA

Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

Uses

  • 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, ethylhexyl palmitate, sorbitol, polyamide-8, benzyl alcohol, tocopherol, caprylic/capric triglyceride, triethanolamine, fragrance, acrylates/C10-30 alkyl acrylate crosspolymer, chlorphenesin, sodium ascorbyl phosphate, oleth-3, disodium EDTA

principal display panel

mountain

falls

*Compare to

Coppertne

non-greasy

SPF 30

Water

Resistant

80 minutes

sport

sunscreen

lotion

BROAD

SPECTRUM

SPF 50

Made in the USA with US and foreign parts

8 FL OZ (236 mL)

mm3

AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0714
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30.3 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE101 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE101 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SORBITOL (UNII: 506T60A25R)  
POLYAMIDE-8 (4500 MW) (UNII: 77723GV81A)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
TOCOPHEROL (UNII: R0ZB2556P8)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
OLETH-3 (UNII: BQZ26235UC)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0869-0714-1874 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/201609/21/2021
2NDC:0869-0714-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/201609/21/2021
3NDC:0869-0714-38296 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/28/201609/21/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02011/28/201609/21/2021
Labeler - Vi-Jon, LLC (088520668)
Registrant - Vi-Jon, LLC (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(0869-0714)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(0869-0714)

Revised: 2/2024
 
Vi-Jon, LLC