SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

sunscreen by

Drug Labeling and Warnings

sunscreen 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 15%

Octisalate 5%

Octocrylene 10%

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

Keep away from fire or flame.

• after application, wait until product dries before approacing a souce of heat or flame, or before smoking

do not use 

• on damaged or broken skin

WHEN USING

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

stop use and ask a doctor if

• rash occurs

keep out of reach of children

if swallowed, get medical help or contact a Poison Conrol Center right away

direction

■ 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 the container from excessive heat and direct sun

inactive ingredients

alcohol denat., octyldodecyl neopentanoate, acrylates/octylacrylamide copolymer, diethylhexyl 2,6-naphthalate, tocopheryl acetate, fragrance

SPL UNCLASSIFIED SECTION

May stain or damage some fabrics of surfaces

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

principal display panel

STUDIO SELECTION

SUN

BEACH GUARD

SUN & WATER

Protection

SUNSCREEN SPRAY

BROAD SPECTRUM SPF 70

Compare to Neutrogena Beach Defense Sunscreen Spray

• Water-Resistant (80 minutes)
• UVA/UVB protection

SPF 70

Octinoxate & Oxybenzone Free

Dermatologist Tested

NET WT 6.5 OZ (184 g)

INGREDIENTS AND APPEARANCE

SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-983
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
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-983-54	184 g in 1 CAN; Type 0: Not a Combination Product	01/18/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/18/2021

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(55910-983)