PINA COLADA BODY SPF 30 BROAD SPECTRUM- classic sunscreen spray

Pina Colada Body by

Drug Labeling and Warnings

Pina Colada Body by is a Otc medication manufactured, distributed, or labeled by Bell International Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Avobenzone 2.0%, Octinoxate 7.5%, Octisalate 4.0%, Octocrylene 7.0%

Purpose

Sunscreen

Uses

helps prevent sunburn. If used as directed with other sun protetion measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Flammable. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 oF. Do not use in the presence of a flame or spark, or while smoking.

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 doctor if skin rash occurs.

Warning (cont)

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

reapply: after 40 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 wtih a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am-2pm, wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6 months: Ask a doctor.

Other Information

may stain some fabrics.

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Alcohol (ORGANIC), Algae Extract (ORGANIC), Aloe Barbadensis Leaf Juice, Cucumis Sativus (ORGANIC Cucumber) Fruit Extract, Flavor, Fragaria Vesca (ORGANIC Strawberry) Fruit Extract, Glycerin (ORGANIC), Hydrogenated Methyl Abietate, Rubus Idaeus (ORGANIC Raspberry) Seed Oil.

8 oz

3.4 oz label

INGREDIENTS AND APPEARANCE

PINA COLADA BODY  SPF 30 BROAD SPECTRUM
classic sunscreen spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76150-119
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	7 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
ALPINE STRAWBERRY (UNII: CG6IX3GCMU)
CUCUMBER (UNII: YY7C30VXJT)
RASPBERRY SEED OIL (UNII: 9S8867952A)
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
ALCOHOL (UNII: 3K9958V90M)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76150-119-23	90 mL in 1 CAN; Type 0: Not a Combination Product	01/01/2013
2	NDC: 76150-119-24	250 mL in 1 CAN; Type 0: Not a Combination Product	01/01/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2013

Labeler - Bell International Laboratories, Inc. (967781555)