INTENSE THERAPY LIP BALM BASIL LEMON- sunscreen skin protectant lip balm ointment

Intense Therapy Lip Balm Basil Lemon by

Drug Labeling and Warnings

Intense Therapy Lip Balm Basil Lemon by is a Otc medication manufactured, distributed, or labeled by Jack Black, LLC, Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warning

Stop use and ask doctor if rash occurs

Children under 6 months: Ask a doctor

Directions

Apply liberally and reapply every 2 hours or after eating, drinking, swimming or wiping lips.

Active Ingredients

Avobenzone 3.0% Sunscreen

Octinoxate 7.5% Sunscreen

Petrolatum 40.2% Skin Protectant

Uses

Helps prevent sunburn and chapped lips.

Keep out of Reach of Children

Keep out of Reach of Children

Inactive Ingredients

beeswax, butyrospermum Parkii (shea) butter, C18-38 alkyl hydroxystearol stearate, camellia sinenesis (green tea) leaf extract, cyclohexasiloxane, cyclopentasiloxane, flavor, lanolin, microcrystalline wax, ozokerite, persea gratissima (avocado) oil, ployglyceryl 3 beeswax, theobroma cacao (cocoa) seed butter, tocopheryl acetate

Questions

www.getjackblack.com

1-877-766-3388

Label

INGREDIENTS AND APPEARANCE

INTENSE THERAPY LIP BALM BASIL LEMON 
sunscreen skin protectant lip balm ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-045
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 g  in 1000 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 g  in 1000 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	402 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
LANOLIN OIL (UNII: OVV5IIJ58F)
WHITE WAX (UNII: 7G1J5DA97F)
CERESIN (UNII: Q1LS2UJO3A)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SHEA BUTTER (UNII: K49155WL9Y)
AVOCADO OIL (UNII: 6VNO72PFC1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)

Product Characteristics
Color		Score
Shape		Size
Flavor	LEMON (Basil Lemon)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-045-25	7 g in 1 TUBE; Type 1: Convenience Kit of Co-Package	06/08/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/08/2018

Labeler - Jack Black, LLC (847024036)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(66738-045)