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

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

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 uner 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 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 or Comments?

Call toll free 1-800-840-5225

PRINCIPAL DISPLAY PANEL - 177 mL Bottle Label

Panama Jack

SPF 50+

BROAD SPECTRUM SPF 50+

CONTINUOUS CLEAR

SUNSCREEN SPRAY

WATER RESISTANT (80 MINUTES)

NON-GREASY FORMULA

QUICK & EVEN COVERAGE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58443-0058
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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	16.3 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	16.3 mg in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	16.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:58443-0058-4	177 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/26/2013	12/31/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	11/26/2013	12/31/2018

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	label(58443-0058) , pack(58443-0058) , manufacture(58443-0058) , analysis(58443-0058)

Revised: 3/2022

Document Id: db0fa9a9-2377-919d-e053-2a95a90a4306

Set id: 2656f411-e596-4c85-8472-01350add9156

Version: 4

Effective Time: 20220325

Prime Enterprises, Inc.