AVOBENZONE, HOMOSALATE, OCTISALATE- avobenzone, homosalate, octisalate spray 
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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Sport Sunscreen Spray SPF 50
D43.000/D43AA

Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Purpose

Sunscreen

Uses

Warnings

For external use only

Flammable

Do not use

on damaged or broken skin

When using this product

Stop use and ask a doctor if 

Keep out of reach of children.

If swallowed, seek immediate medical attention or call a poison control center right away.

Directions

■ spray liberally and spread evenly by hand 15 minutes before sun exposure
■ apply to all skin exposed to the sun
■ hold container 4 to 6 inches from the skin to apply
■ do not spray directly into face. Spray on hands then apply to face.
■ do not apply in windy conditions
■ use in a well-ventilated area and avoid inhalation
■ 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 in this container from excessive heat and direct sun

Inactive ingredients

alcohol denat., diethylhexyl 2,6-naphthalate, diisopropyl adipate, acrylates/octylacrylamide copolymer, butyloctyl salicylate, neopentyl glycol diheptanoate, fragrance, amyl cinnamal, hydroxycitronellal, linalool, tocopheryl acetate

Disclaimer

May stain or damage some fabrics or surfaces

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone® Sunscreen Spray Sport Broad Spectrum SPF 50.

Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLA, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

Principal display panel

STUDIO SELECTION SUN

SPORT SUNSCREEN SPRAY

BROAD SPECTRUM SPF 50

Compare to Coppertone® Sunscreen Spray Sport Broad Spectrum SPF 50*

SPF 50

NET WT 5.5 OZ (156 g)

image description

AVOBENZONE, HOMOSALATE, OCTISALATE 
avobenzone, homosalate, octisalate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75712-943
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE120 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75712-943-14156 g in 1 CAN; Type 0: Not a Combination Product09/29/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/29/2023
Labeler - Old East Main Co. (006946172)
Registrant - Vi-Jon, LLC. (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC.790752542manufacture(75712-943)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC.088520668manufacture(75712-943)

Revised: 9/2023
Document Id: 8e1e5819-9162-45ce-97a5-ae29f47ed073
Set id: 4a0cab2d-3c73-4b0b-b0c4-f72b1a0de1cf
Version: 1
Effective Time: 20230929
 
Old East Main Co.