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., Consumer Product Partners, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 15%

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, 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, neopentyl glycol diheptanoate, butyloctyl salicylate, acrylates/octylacrylamide copolymer, fragrance, amyl cinnamal, hydroxycitronellal, linalool, tocopheryl acetate

Disclaimer

May stain or damage some fabrics or surfaces

OXTINOXATE FREE, OXYBENZONE FREE

*This product is not manufactured or distributed by Beiersdorf AG, distributor of Coppertone ®Sunscreen Spray Sport Broad Spectrum SPF 70.

Adverse Reaction

DISTRIBUTED BY OLD EST MAIN CO.

100 MISSION RIDGE

GOODLETSVILLE, TN 37072

100% Satisfaction Guaranteed!

(888) 309-9030

Principal display panel

STUDIO SLECTION SUN

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 70

Compare to Coppertone ®Sunscreen Spray Sport Broad Spectrum SPF 70*

• Water-Resistant (80 minutes)
• Continuous spray from any angle

SPF 70

dermatologist-Tested

Hypoallergenic

NET WT 5.5 OZ (156 g)

INGREDIENTS AND APPEARANCE

AVOBENZONE, HOMOSALATE, OCTISALATE 
avobenzone, homosalate, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75712-946
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	150 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)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (40000 MW) (UNII: 7LL6SY9YFV)
.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: 75712-946-14	156 g in 1 CAN; Type 0: Not a Combination Product	08/24/2023
2	NDC: 75712-946-39	312 g in 1 CAN; Type 0: Not a Combination Product	08/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/24/2023

Labeler - Old East Main Co. (006946172)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(75712-946)