PANAMA JACK SPF 4- octinoxate oil

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

Octinoxate 2 %

PURPOSE

Purpose

Sunscreen

Uses

• helps prevent sunburn

Warnings

Skin Cancer/Skin Aging Alert. Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin 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.

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
  • at least every 2 hours
• children under 6 months: Ask a doctor

Inactive Ingredients

Aloe Barbadensis Extract, Arachis Hypogaea (Peanut) Oil, Citrus Medica Limonum (Lemon) Peel Oil, Cocos Nucifera (Coconut) Oil, Fragrance, Mineral Oil, Olea Europaea (Olive) Fruit Oil, Propylparaben, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Theobroma Cacao (Cocoa) Seed Butter

Other information

• protect this product from excessive heat and direct sun

QUESTIONS

Questions or Comments?

Call toll free 1-800-840-5225            www.panamajack.com

PRINCIPAL DISPLAY PANEL - 237 mL  Bottle Label

Panama jack

SPF 4

Dark

Tanning Oil

Exotic Natural Oils

Fruit & Nut Extracts

Light Sunscreen Formula

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

PANAMA JACK  SPF 4
octinoxate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	16.8 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PEANUT OIL (UNII: 5TL50QU0W4)
LEMON OIL (UNII: I9GRO824LL)
MINERAL OIL (UNII: T5L8T28FGP)
COCONUT OIL (UNII: Q9L0O73W7L)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OLIVE OIL (UNII: 6UYK2W1W1E)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ALMOND OIL (UNII: 66YXD4DKO9)
COCOA BUTTER (UNII: 512OYT1CRR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0066-3	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/24/2013

Labeler - Prime Enterprises, Inc. (101946028)

Registrant - Prime Enterprises, Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises, Inc.		101946028	label(58443-0066) , pack(58443-0066) , manufacture(58443-0066) , analysis(58443-0066)