Active Ingredients

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 4%

Purpose

Sunscreen

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

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Keep away from face to avoid breathing it.
Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Flammable: Do not use near heat, flame or while smoking.

spray liberally and spread evenly by hand 15 minutes before sun exposure
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
reapply:
after 80 minutes of swimming and 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 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-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), Tocopheryl Acetate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Biocycle laboratories, Inc. 16363 NW 49 Avenuw, Miami, FL 33014

Principal Display Label

SUNTONE SPORT SUNSCREEN BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.5 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.5 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.38 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	34 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	85 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
VINYL ACETATE (UNII: L9MK238N77)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0130-4	177 mL in 1 CAN; Type 0: Not a Combination Product	04/16/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/16/2018

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises Inc		101946028	manufacture(13630-0130) , analysis(13630-0130)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging Inc.		805987059	pack(13630-0130) , label(13630-0130)