SUNTONE FIT FOR THE SUN SPORT SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Suntone by

Drug Labeling and Warnings

Suntone by is a Otc medication manufactured, distributed, or labeled by Prime Packaging Inc., Prime Enterprises Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 2%

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

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.

Directions

• 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 snscreen 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

Inactive ingredients

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

Other information

• protect this product from excessive heat and direct sun
• avoid spraying on fabrics - could cause discoloration

Questions or comments?

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

Suntone Sport Sunscreen Continuous Spray Broad Spectrum SPF 30

INGREDIENTS AND APPEARANCE

SUNTONE  FIT FOR THE SUN SPORT SUNSCREEN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	24.9 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	41.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	22.83 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	16.6 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	62.25 mg  in 1 mL

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

Product Characteristics
Color	yellow (Colorless to light yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0129-4	177 mL in 1 CAN; Type 0: Not a Combination Product	04/16/2018

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

Labeler - Prime Packaging Inc. (805987059)

Registrant - Prime Packaging Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc		101946028	manufacture(13630-0129) , analysis(13630-0129)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging Inc.		805987059	pack(13630-0129) , label(13630-0129)