AVOBENZONE, HOMOSALATE, OCTISALATE- avobenzone, homosalate, octisalate lotion 
Old East Main Co.

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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Sheer Touch Sunscreen SPF 100
D34.000/D34AA

Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Purpose

Sunscreen

Uses

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control right away.

Directions

Other information

Inactive ingredients

water, diethylhexyl 2,6-naphthalate, styrene/acrylates copolymer, butyloctyl salicylate, silica, glyceryl stearate, PEG-100 stearate, potassium cetyl phosphate, beeswax, behenyl alcohol, acrylates/C12-22 alkyl methacrylate copolymer, benzyl alcohol, fragrance, xanthan gum, chlorphenesin, sodium polyacrylate, glycerin, disodium EDTA, BHT, trideceth-6, pentylene glycol

Adverse Reaction

May stain or damage some fabrics or surfaces.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE,

GOODLETTSVILLA, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

Principal display panel

STUDIO SELECTION SUN

SHEER TOUCH SUNSCREEN LOTION

BROAD SPECTRUM SPF 100

UVA/UVB SUNSCREEN

SPF 100

Dermatologist-Tested

UVA/UVB Sunscreen

3 FL OZ (88 mL)

image description

AVOBENZONE, HOMOSALATE, OCTISALATE 
avobenzone, homosalate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75712-934
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate150 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
DOCOSANOL (UNII: 9G1OE216XY)  
BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
TRIDECETH-6 (UNII: 3T5PCR2H0C)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75712-934-2188 mL in 1 TUBE; Type 0: Not a Combination Product08/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/25/2023
Labeler - Old East Main Co. (006946172)
Registrant - Vi-Jon, LLC (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(75712-934)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(75712-934)

Revised: 8/2023
Document Id: 4d9f1900-c749-4182-b57b-a6d4459b2db8
Set id: cea1c223-c9d4-42ac-8c5b-c0ca647d57a1
Version: 2
Effective Time: 20230828
 
Old East Main Co.