SUNTONE BROAD SPECTRUM SPF 8- avobenzone, octisalate, octocrylene and 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 1 %, Octisalate 3 %, Octocrylene 0.85 %, and Oxybenzone 1 %

PURPOSE

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

For exernal 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 0F

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 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 well-ventilated areas.
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• children under 6 months: Ask a doctor

Inactive Ingredients

C12-15 Alkyl Benzoate, Fragrance (Parfum), SD Alcohol 40-B (Alcohol Denat.), VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

• protect this product from excesive heat and direct sun
• may stain some fabrics

QUESTIONS

Questions or Comments? Biocycle Laboratories, Inc.

 16363 NW 49 Avenue, Miami FL 33014

PRINCIPAL DISPLAY PANEL - 177 mL Can Label

Suntone

Fit for the Sun

Sunscreen

Continuous Spray

BROAD SPECTRUM SPF 8

Water Resistant (80 minutes)

Non-Greasy Formula

8

6 FL.OZ./ 177mL

INGREDIENTS AND APPEARANCE

SUNTONE  BROAD SPECTRUM SPF 8
avobenzone, octisalate, octocrylene and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0046
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	8.1 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	24.3 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	6.9 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	8.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALCOHOL (UNII: 3K9958V90M)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0046-4	177 mL in 1 CAN; Type 0: Not a Combination Product	03/21/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/21/2013

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0046) , analysis(13630-0046)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0046) , pack(13630-0046)