PANAMA JACK BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Panama Jack by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Avobenzone 3 %, Homosalate 10 %, Octisalate 5 %, Octocrylene 2.75 %, and Oxybenzone 4 %

PURPOSE

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.

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 no 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 evenly spread 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 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
• 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

Inactive Ingredients

Diethylhexyl 2,6-Naphthalate, Fragrance, Polyester-8, 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  Bottle Label

Panama Jack

Kids

SPF 50+

BROAD SPECTRUM

SPF 50+

CONTINUOUS CLEAR

SUNSCREEN SPRAY

WATER RESISTANT (80 MINUTES)

Hypo-Allergenic

Non-Greasy Formula

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

PANAMA JACK  BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	25.5 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	85 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	42.5 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	23.4 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	34 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
ALCOHOL (UNII: 3K9958V90M)
DIBUTYL MALEATE (UNII: 4X371TMK9K)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0057-4	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/26/2013

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0057) , pack(58443-0057) , manufacture(58443-0057) , analysis(58443-0057)