Active Ingredients

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

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. Keep away from face to avoid breathing it. Contents under pressure - do not puncture or incinerate. Do not store at temperatures above 120°F.

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 not use near heat, flame or while smoking.

Directions

Spray liberally and spray evenly by hand 15 minutes before sun exposure
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
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-sleeved shirts, pants, hats, and sunglasses
Children under 6 months: Ask a doctor

Inactive ingredients

Fragrance, SD Alcohol 40-B, Trimethoxybenzylidene Pentanedione, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

Other information

Protect this product from excessive heat and direct sun.
Avoid spraying on fabrics-could cause discoloration.

Questions or comments?

Call toll free 1-800-840-5225

Panama Jack 100 Broad Spectrum SPF 100 Sunscreen Spray

Principal Display Label

PAMANA JACK BROAD SPECTRUM SPF 100
avobenzone, homosalate, octisalate, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:13630-0147
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	26.01 mg in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	130.05 mg in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	43.35 mg in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	86.7 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
VINYL ACETATE (UNII: L9MK238N77)
DIBUTYL MALEATE (UNII: 4X371TMK9K)
ISOBORNYL ACRYLATE (UNII: IX0PRH184P)
ALCOHOL (UNII: 3K9958V90M)
TRIMETHOXYBENZYLIDENE PENTANEDIONE (UNII: 322V0ACF25)

Product Characteristics
Color	yellow	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:13630-0147-4	178 mL in 1 CAN; Type 0: Not a Combination Product	03/14/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	03/14/2019

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Enterprises, Inc.		101946028	manufacture(13630-0147) , analysis(13630-0147)

Name	Address	ID/FEI	Business Operations
Establishment
Prime Packaging, Inc.		805987059	pack(13630-0147) , label(13630-0147)