PANAMA JACK BROAD SPECTRUM SPF 100 SPORT SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion 
Prime Enterprises Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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100 Broad Spectrum SPF 100 Panama Jack Sport Sunscreen Lotion

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

Principal Display Label

PANAMA JACK  BROAD SPECTRUM SPF 100 SPORT SUNSCREEN
avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58443-0257
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE38.04 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.58 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47.55 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE26.15 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE142.65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58443-0257-389 mL in 1 BOTTLE; Type 0: Not a Combination Product03/21/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35203/21/2018
Labeler - Prime Enterprises Inc. (101946028)
Registrant - Prime Enterprises Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises Inc.101946028pack(58443-0257) , manufacture(58443-0257) , label(58443-0257) , analysis(58443-0257)

Revised: 1/2020
Document Id: 9c5a6c34-4832-6756-e053-2a95a90a1417
Set id: 67f2d7ad-d646-44c6-e053-2991aa0a8bb9
Version: 2
Effective Time: 20200117
 
Prime Enterprises Inc.