Panama Jack Sport Broad Spectrum SPF 8 Sunscreen Spray

Panama Jack by

Drug Labeling and Warnings

Panama Jack by is a Otc medication manufactured, distributed, or labeled by Prime Packaging, Inc., Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PANAMA JACK BROAD SPECTRUM SPF 8- avobenzone, octocrylene spray 
Prime Packaging, 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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Panama Jack Sport Broad Spectrum SPF 8 Sunscreen Spray

Active Ingredients

Avobenzone 2%

Octocrylene 2%

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sunincreases your risk of skin cancer and early sking aging. This product has been shown on ly to prevent sunburn, not skin cancer or early sking 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. 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.

Directions

• Spray liberally and spray evenly by hand 15 minutes before sun exposure
• Reapp ly:
• after 80 minutes of swimming or sweating.
• immediate ly after towel drying.
• at least every 2 hours.
• 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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Fragrance, Isopropylphthalimide, Oleth-10, Phenoxyethanol, Propylene Glycol, Retinyl Palmitate, Sodium Hydroxide, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Trimethylsiloxysilicate, Ubiquinone, Water

Other information

• protect this product from excessive heat and direct sun.
• May stain some fabrics

Questions or comments?

Call toll free 1-800-840-5225

Panama Jack Sport Broad Spesctrum SPF 50

PANAMA JACK  BROAD SPECTRUM SPF 8
avobenzone, octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13630-0189
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	19.4 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	19.4 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
COCOA BUTTER (UNII: 512OYT1CRR)
N-BUTYLPHTHALIMIDE (UNII: 5TH1DKT35E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
OLETH-10 (UNII: JD797EF70J)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
UBIDECARENONE (UNII: EJ27X76M46)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CARAMEL (UNII: T9D99G2B1R)
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)

Product Characteristics
Color	brown (Caramel)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13630-0189-4	160 mL in 1 CAN; Type 0: Not a Combination Product	01/03/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/03/2019

Labeler - Prime Packaging, Inc. (805987059)

Registrant - Prime Packaging, Inc. (805987059)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	manufacture(13630-0189) , analysis(13630-0189)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Packaging, Inc.		805987059	label(13630-0189) , pack(13630-0189)

Revised: 11/2021

Document Id: d0898bca-0793-7825-e053-2a95a90a7098

34390-5

Set id: d0898bbe-3ad4-56f5-e053-2a95a90a0d6a

Version: 1

Effective Time: 20211111