Panama Jack Spf 15 (Ocinoxate, Octisalate, And Oxybenzone) Spray [Prime Packaging, Inc.] -

PANAMA JACK SPF 15 (OCINOXATE, OCTISALATE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]
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NDC	13630-0030-4
Set ID	8650652f-7ce4-46b3-ade5-1a993a50f33d
Category	HUMAN OTC DRUG LABEL
Packager	Prime Packaging, Inc.
Generic Name
Product Class
Product Number
Application Number	PART352

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Active ingredients

Octinoxate 5 %, Octisalate 3 %, Oxybenzone 2 %
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 sunbrun, 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. Keep away from face to avoid breathing it.

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. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120 0F
Directions
- spray liberally and spread evenly by hand 15 minutes before sun exposure
- reapply:
  - after 80 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 with 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
- Hold container 4 to 6 inches from the skin to apply
- Do not spray directly into face. Spray hands then apply to face.
- Do not apply in windy conditions. Use in well ventilated areas.
Inactive Ingredients

C12-15 Alkyl Benzoate, Fragrance, SD Alcohol 40-B, 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?

Call toll free 1-800-840-5225
PRINCIPAL DISPLAY PANEL - 177 mL Can Label

Panama Jack

SPF

15

CONTINUOUS CLEAR

SUNSCREEN SPRAY

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

QUICK & EVEN COVERAGE

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

PANAMA JACK SPF 15
ocinoxate, octisalate, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0030
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	40.8 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	24.5 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	16.3 mg in 1 mL

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

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0030-4	177 mL in 1 CAN; Type 0: Not a Combination Product	12/30/2011

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	12/30/2011

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0030) , analysis(13630-0030)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	label(13630-0030) , pack(13630-0030)

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Medic

PANAMA JACK SPF 15 (OCINOXATE, OCTISALATE, AND OXYBENZONE) SPRAY [PRIME PACKAGING, INC.]

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