JACK BLACK INTENSE THERAPY LIP BALM PASSION FRUIT- avobenzone, octinoxate lip balm sunscreen ointment

Jack Black Intense Therapy Lip Balm Passion Fruit by

Drug Labeling and Warnings

Jack Black Intense Therapy Lip Balm Passion Fruit 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.

Keep out of reach of children

Keep out of reach of children

Active Ingredients

avobenzone   3.0%   sunscreen

octinoxate   7.5%   sunscreen

petrolatum   40.2%   skin protectant

Uses

Helps prevent sunburn and chapped lips.

Uses

Helps prevent sunburn and chapped lips.

Directions

Apply liberally 15 minutes before sun exposure. Children under 6 months: ask a doctor.

Inactive Ingredients

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

Questions

www.getjackblack.com

1-877-766-3388

Labeling

INGREDIENTS AND APPEARANCE

JACK BLACK INTENSE THERAPY LIP BALM PASSION FRUIT 
avobenzone, octinoxate lip balm sunscreen ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-065
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 g  in 100 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	402 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
COCOA BUTTER (UNII: 512OYT1CRR)
LANOLIN (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
CERESIN (UNII: Q1LS2UJO3A)
AVOCADO OIL (UNII: 6VNO72PFC1)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-065-25	7 g in 1 TUBE; Type 0: Not a Combination Product	08/03/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/03/2020

Labeler - Jack Black, LLC (847024036)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(66738-065)