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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Sunscreen Spray for Kids SPF 50
D42.000/D42AA

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 

rash occurs

Keep out of reach of children.

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

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

May stain or damage some fabrics or surfaces

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

DISTRIBUTED BY:

Old East Main Co.

100 Mission Ridge

Goodlettsville, TN 37072

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

May stain or damage some fabrics or surfaces

Principal display panel

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

SUNSCREEN SPRAY FOR KIDS

BROAD SPECTRUM SPF 50

WATER RESISTANT (80 MINUTES)

UVA/UVB sunscreen

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:55910-442
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:55910-442-14156 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product08/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/25/2023
Labeler - Old East Main Co. (068331990)
Registrant - Vi-Jon, LLC. (088520668)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC.790752542manufacture(55910-442)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC.088520668manufacture(55910-442)

Revised: 8/2023
Document Id: 25e13317-68a8-4378-bb61-e65369309fa7
Set id: b3d2da09-d9c9-4c27-82fe-a434ece2f099
Version: 2
Effective Time: 20230814
 
Old East Main Co.