PANAMA JACK BROAD SPECTRUM SPF 100 SPORT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone 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

Avobenzone 3% Octocrylene 2.75%

Homosalate 15% Oxybenzone 4%

Octisalate 5%

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.

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

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

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Butylphthalimide, Cetyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Fragrance, Isopropylphthalimide, Phenoxyethanol, Phenyl Trimethicone, Polyethylene, Potassium Cetyl Phosphate, Potassium Hydroxide, Propylene Glycol, Silica, Stearyl Alcohol, Styrene/Acrylates Copolymer, Tocopheryl Acetate, Ubiquinone, Undecylcrylene Dimethicone, Water

Other information

may stain some fabrics.

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free 1-800-840-5225

100 Broad Spectrum SPF 100 Panama Jack SPORT Sunscreen Lotion

INGREDIENTS AND APPEARANCE

PANAMA JACK  BROAD SPECTRUM SPF 100 SPORT SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0257
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	38.04 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	28.58 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	47.55 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	26.15 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	142.65 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UBIDECARENONE (UNII: EJ27X76M46)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
UNDECYLCRYLENE DIMETHICONE (10000 MW) (UNII: HA26P2LA4P)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0257-3	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/21/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	03/21/2018

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	pack(58443-0257) , manufacture(58443-0257) , label(58443-0257) , analysis(58443-0257)