INTENSE THERAPY LIP BALM WINTER MELON- sunscreen skin protectant lip balm ointment

Intense Therapy Lip Balm Winter Melon by

Drug Labeling and Warnings

Intense Therapy Lip Balm Winter Melon 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]

Warnings

Stop use and ask doctor if rash occurs

Children under 6 months: Ask a doctor

Active Ingredients

Avobenzone 3.0% Sunscreen

Octinoxate 7.5% Sunscreen

Petrolatum 40.2% Skin Protectant

Directions

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

Keep out of Reach of Children

Keep out of Reach of Children

Uses

Helps prevent sunburn and chapped lips.

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 WINTER MELON 
sunscreen skin protectant lip balm ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-048
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-048-25	7 g in 1 TUBE; Type 0: Not a Combination Product	06/27/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	06/27/2018

Labeler - Jack Black, LLC (847024036)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(66738-048)