JACK BLACK LAVENDER LIP BALM 0.25OZ- lip balm sunscreen ointment

Jack Black Lavender Lip Balm 0.25oz by

Drug Labeling and Warnings

Jack Black Lavender Lip Balm 0.25oz by is a Otc medication manufactured, distributed, or labeled by Jack Black, L.L.C., Swiss-American CDMO, 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

Uses

Helps prevent sunburn and chapped lips.

Uses

Helps prevent sunburn and chapped lips.

Warnings

Stop use if skin rash occurs.

Directions

Apply liberally and reapply every 2 hours or after eating, drinking, swimming or wiping lips. Children under 6 months of age: 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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN 

Questions

Made in USA for Jack Black, LLC
Carrollton, TX 75006
1-877-766-3388 www.getjackblack.com

Labeling

INGREDIENTS AND APPEARANCE

JACK BLACK LAVENDER LIP BALM 0.25OZ 
lip balm sunscreen ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-302
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
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WHITE WAX (UNII: 7G1J5DA97F)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
LANOLIN OIL (UNII: OVV5IIJ58F)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
CERESIN (UNII: Q1LS2UJO3A)
AVOCADO OIL (UNII: 6VNO72PFC1)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-302-25	7 g in 1 TUBE; Type 0: Not a Combination Product	03/03/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/03/2021

Labeler - Jack Black, L.L.C. (847024036)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(66738-302)