AVOBENZONE, HOMOSALATE, OCTISALATE spray

Avobenzone, Homosalate, Octisalate by

Drug Labeling and Warnings

Avobenzone, Homosalate, Octisalate by is a Otc medication manufactured, distributed, or labeled by Old East Main Co., Vi-Jon, LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 12%

Octisalate 5%

Purpose

Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risK of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Flammable

• Flammable: keep away from fire or flame. 
• After application, wait until product dries before approaching a source of heat or flame, or before smoking

Do not use

on damaged or broken skin

When using this product

• keep out of eyes. Rinse with water to remove
• contents under pressure.  Do not puncture or incinerate.  Do not store at temperature above 120°F

Stop use and ask a doctor if 

rash occurs

Keep out of reach of children.

If swallowed, get medical help or contact 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

OCTINOXATE FREE, OXBENZONE FREE

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

Adverse reaction

100% Satisfaction Guarnteed!

(888) 309-9030

DISTRIBUTED BY: Old East Main Co.

100 Mission Ridge

Goodlettsville, TN 37072

Principal display panel

STUDO SELECTION ®SUN

SUNSCREEN SPRAY FOR KIDS

BROAD SPECTRUM SPF 50

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

• WATER RESISTANT (80 MINUTES)
• UVA/UVB sunscreen

SPF 50

Family Size

NET WT 11oz (312 g)

INGREDIENTS AND APPEARANCE

AVOBENZONE, HOMOSALATE, OCTISALATE 
avobenzone, homosalate, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-442
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	120 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-442-14	156 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/11/2023
2	NDC: 55910-442-39	312 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	08/11/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/25/2023

Labeler - Old East Main Co. (068331990)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(55910-442)