SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene spray

Sunscreen by

Drug Labeling and Warnings

Sunscreen by is a Otc medication manufactured, distributed, or labeled by DOLGENCORP, LLC, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

active ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 8%

purpose

Sunscreen

use

■ 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 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 pumcture 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 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 ingredient

alcohol denat., neopentyl glycol diheptanoate, polyester-7, tocopherol, fragrance

other information

May stain or damage some fabrics or surfaces

This product is not manufactured or distributed by Edgewell Personal Care, distributor of Banana Boat Sport Performance CoolZone Clear Sunscreen Spray UVA/UVB Broad Spectrum SPF 30

SPL UNCLASSIFIED SECTION

100% Satisfaction Guaranteed!

(888)309-9030

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

083.000/083AA

principal display panel

STUDIO SELECTION

SUN SPORT SUNSCREEN SPRAY

BROAD SPECTRUM SPF 30

Compare to Banana Boat Sport

Performance Broad Spectrum SPF 30

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

SPF 30

Octinoxate, Oxybenzone & Paraben Free

NET WT 5.5 OZ (156 g)

INGREDIENTS AND APPEARANCE

SUNSCREEN 
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-564
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	90 g  in 1 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	2250 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	250 g  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	8 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
POLYESTER-7 (UNII: 0841698D2F)
TOCOPHEROL (UNII: R0ZB2556P8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-564-14	156 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/01/2019

Labeler - DOLGENCORP, LLC (068331990)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(55910-564)