PANAMA JACK SPF 4- octocrylene lotion

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

Octocrylene 2%

Purpose

Sunscreen

Uses

helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Specnding 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

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Carbomer, Cetyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Polyethylene, Propylene Glycol, Sodium Hydroxide, Stearyl Alcohol, Tocopheryl Acetate, Ubiquinone, Water, Xanthan Gum

Other information

protect this product from excessive heat and direct sun

avoid contact with fabrics - could cause discoloration

Questions or comments?

Call toll free 1-800-840-5225

Panama Jack 4 SPF 4 Sunscreen Lotion

INGREDIENTS AND APPEARANCE

PANAMA JACK  SPF 4
octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0289
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	19.12 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
UBIDECARENONE (UNII: EJ27X76M46)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PEG-100 STEARATE (UNII: YD01N1999R)
CARBOMER 980 (UNII: 4Q93RCW27E)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0289-4	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2019

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0289) , manufacture(58443-0289) , label(58443-0289) , analysis(58443-0289)