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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Moisturizing Sunscreen Lotion SPF 50
D54.000/D55AA

Active Ingredients

Avobenzone 3%

Homosalate 12%

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 Center right away

Directions

Other Information

Inactive ingredients

water, diethylhexyl 2,6-naphthalate, butyloctyl salicylate, styrene/acrylates copolymer, aluminum starch octenylsuccinate, neopentyl glycol diheptanoate, glyceryl stearate, silica, polyester-7, beeswax, acrylates/C10-30 alkyl acrylate crosspolymer, glycerin, potassium hydroxide, chlorphenesin, tocopherol, benzyl alcohol, arachidyl alcohol, fragrance, PEG-100 stearate, behenyl alcohol, arachidyl glucoside, disodium EDTA, amyl cinnamal, sodium ascorbyl phosphate

Adverse Reactions

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone® Complete Sunscreen Lotion SPF 50.

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

Principal Panel Display

STUDIO SELECTION SUN

MOISTURIZING SUNSCREEN LOTION

BROAD SPECTRUM SPF 50

Compare to Coppertone® Complete Sunscreen Lotion Broad Spectrum SPF 50*

SPF 50

Dermatologist-Tested

UVA/UVB Sunscreen

3 FL OZ (89 mL)

image description

AVOBENZONE, HOMOSALATE, OCTISALATE 
avobenzone, homosalate, octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75712-954
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) HOMOSALATE120 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)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
POLYESTER-7 (UNII: 0841698D2F)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TOCOPHEROL (UNII: R0ZB2556P8)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
PEG-100 STEARATE (UNII: YD01N1999R)  
DOCOSANOL (UNII: 9G1OE216XY)  
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75712-954-2189 mL in 1 TUBE; Type 0: Not a Combination Product08/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/24/2023
Labeler - Old East Main Co. (006946172)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(75712-954)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(75712-954)

Revised: 8/2023
Document Id: f437da1f-4847-4990-94e0-966865ed4946
Set id: 32036e41-2414-4498-8e1c-61511abf7a32
Version: 2
Effective Time: 20230828
 
Old East Main Co.