JACK BLACK INTENSIVE THERAPY LIP BALM MANGO CHILI LIME- avobenzone, octinoxate lip balm sunscreen ointment

Jack Black Intensive Therapy Lip Balm Mango Chili Lime by

Drug Labeling and Warnings

Jack Black Intensive Therapy Lip Balm Mango Chili Lime 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 a 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 and as needed. 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 INTENSIVE THERAPY LIP BALM MANGO CHILI LIME 
avobenzone, octinoxate lip balm sunscreen ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-063
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 (UNII: 7EV65EAW6H)
YELLOW WAX (UNII: 2ZA36H0S2V)
CERESIN (UNII: Q1LS2UJO3A)
SHEA BUTTER (UNII: K49155WL9Y)
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: 66738-063-25	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(66738-063)