Active ingredients

Octinoxate 2 %

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 external use only

Do not use on damaged or broken skin.

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

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.

Directions

apply liberally 15 minutes before sun exposure.
do not spray directly into face. Spray on hands then apply to face
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hour
children under 6 months: ask a doctor.

Inactive Ingredients

Aloe Barbadensis Extract, Cocos Nucifera (Coconut) Oil, Fragrance (Parfum), Mineral Oil (Paraffinum Liquidum), Propylparaben, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate

Other information

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

Questions or Comments?

Biocycle Laboratories, Inc.

16363 NW 49 Avenue

Miami, FL 33014

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

Suntone

Fit for the Sun

DARK TANNING

Sunscreen Spray Oil

SPF 4

Water Resistant

(80 Minutes)

Contains Aloe Vera

8 FL. OZ./236mL

SUNTONE BROAD SPECTRUM SPF 4
octinoxate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0098
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	16.7 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)
MINERAL OIL (UNII: T5L8T28FGP)
ALOE VERA FLOWER (UNII: 575DY8C1ER)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0098-4	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/18/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/18/2013

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0098) , pack(58443-0098) , manufacture(58443-0098) , analysis(58443-0098)