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 30
D41.000/D41AA

Active Ingredients

Avobenzone 3%

Homosalate 10%

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

rash occurs

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, acrylates/octylacrylamide copolymer, diisopropyl adipate, neopentyl glycol diheptanoate, butyloctyl salicylate, 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, distributer of Coppertone® Sunscreen Spray Broad Spectrum SPF 30.

Adverse Reaction

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLA, TN 37072

Principal display panel

STUDIO SELECTION SUN

Sport

Sunscreen Spray

BROAD SPECTRUM SPF 30

Compare to Coppertone® Sunscreen Spray Sport Broad Spectrum SPF 30*

SPF 30

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:75712-941
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) HOMOSALATE100 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)  
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)  
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)  
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75712-941-14156 g in 1 CAN; Type 0: Not a Combination Product09/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/05/2023
Labeler - Old East Main CO. (006946172)
Registrant - Vi-Jon, LLC. (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC.790752542manufacture(75712-941)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC.088520668manufacture(75712-941)

Revised: 9/2023
Document Id: 383f4932-7a9b-42b7-ad1c-900df878842e
Set id: ba9331ef-3744-4072-80a2-af95c6f7ee05
Version: 1
Effective Time: 20230905
 
Old East Main CO.