PANAMA JACK SPF 4 DARK TANNING OIL- 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

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 or comments?

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

Panama Jack SPF 4 Dark Tanning Oil

INGREDIENTS AND APPEARANCE

PANAMA JACK  SPF 4 DARK TANNING OIL
octinoxate oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58443-0201
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 100 g

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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58443-0201-4	198.7 g in 1 BOTTLE; Type 0: Not a Combination Product	12/15/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	12/15/2011

Labeler - Prime Enterprises Inc. (101946028)

Registrant - Prime Enterprises Inc. (101946028)

Establishment
Name	Address	ID/FEI	Business Operations
Prime Enterprises Inc.		101946028	manufacture(58443-0201) , pack(58443-0201) , label(58443-0201)