INTENSE THERAPY LIP BALM SPF25, SHEA BUTTER AND VITAMIN E- lip balm spf25 ointment

Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E by

Drug Labeling and Warnings

Intense Therapy Lip Balm SPF25, Shea Butter and Vitamin E by is a Otc medication manufactured, distributed, or labeled by Jack Black, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Avobenzone 3.0%   Sunscreen

Octinoxate 7.5%      Sunscreen

Petrolatum 40.2%     Skin Protectant

Use

Helps prevent sunburn and chapped lips

Warning

Stop use if skin rash occurs

Directions

Apply liberally 15 minutes before sun exposure and as needed.  Children under 6 monhts: ask a doctor.

Inactive Ingredients

Beeswax, Butyrospermum parkii (Shea) Butter, C 18-38 Alkyl Hydroxystearoyl Stearate, Camellia Sinensis (Green tea) Leaf Extract, Cyclohexasiloxane, Cyclopentasiloxane, Flavor, Lanolin, Microcyrstalline Wax, Ozokerite, Persea gratissima (avocado) oil, Polyglyceryl-3 Beeswax, Theobroma cacao (cocoa) See Butter, Tocopheryl Acetate

Questions

1-877-766-3388

www.getjackblack.com

Label

INGREDIENTS AND APPEARANCE

INTENSE THERAPY LIP BALM SPF25, SHEA BUTTER AND VITAMIN E 
lip balm spf25 ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 1000 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	40.2 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
WHITE WAX (UNII: 7G1J5DA97F)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
LANOLIN OIL (UNII: OVV5IIJ58F)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
AVOCADO OIL (UNII: 6VNO72PFC1)
CERESIN (UNII: Q1LS2UJO3A)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Product Characteristics
Color	yellow (Light Amber Ointment)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-030-22	7 g in 1 TUBE; Type 0: Not a Combination Product	08/10/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/10/2011

Labeler - Jack Black, LLC (847024036)