JACK BLACK SHAVE ESSENTIALS by Jack Black L.L.C. / Swiss American CDMO

JACK BLACK SHAVE ESSENTIALS by

Drug Labeling and Warnings

JACK BLACK SHAVE ESSENTIALS by is a Otc medication manufactured, distributed, or labeled by Jack Black L.L.C., Swiss American CDMO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

JACK BLACK SHAVE ESSENTIALS- avobenzone, octinoxate lotion 
Jack Black L.L.C.

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Active Ingredient

Avobenzone 2.2%, Octinoxate 7.5%

Purpose

Sunscreen

Use

Moisturizes and helps prevent sunburn.

Warnings

For external use only

Do not use on damaged or broken skin

Stop use and ask doctor if rash occurs

When using this product keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

If swallowed, get medical help or contact Poison Control Center right away.

Directions

Apply liberally 15 minutes before sun exposure

Use a water-resistant sunscreen if swimming or sweating

Reapply at least every two hours

Children under 6 months: Ask a doctor

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad-spectrum SPF value of 15 or higher Limit time in the sun, especially from 10 a.m.–2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

Aqua (Water), Cyclopentasiloxane, Octyldodecyl Neopentanoate, Phenethyl Benzoate, Dimethicone, Glycereth-26, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Phenoxyethanol, Hydroxypropyl Starch Phosphate, Cetearyl Glucoside, Carbomer, Pyrus Malus (Apple) Fruit Extract, Butylene Glycol, Sodium Hydroxide, Disodium EDTA, Sodium Hyaluronate, Lavandula Angustifolia (Lavender) Oil, Iodopropynyl Butylcarbamate, Pelargonium Graveolens Flower Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lecithin, Melissa Officinalis Extract, Haslea Ostrearia Extract, Palmaria Palmata Extract, Calendula Officinalis Flower Extract*, Glycerin, Leontopodium Alpinum (Edelweiss) Extract*, Retinyl Palmitate, Tocopheryl Acetate, Anthemis

Nobilis Flower Oil, Peucedanum Ostruthium Leaf Extract*, Buddleja Davidii Leaf Extract*, Artemisia Umbelliformis Extract*

*Certified Organic

Other Information

Protect product from excessive heat and direct sunlight

You may report a serious adverse reaction from using this product to Jack Black at 1-877-766-3388.

Questions?

1-877-766-3388

www.getjackblack.com

JACK BLACK SHAVE ESSENTIALS 
avobenzone, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-541
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
HASLEA OSTREARIA (UNII: Y87200QHN9)
MELISSA OFFICINALIS (UNII: YF70189L0N)
ALCOHOL (UNII: 3K9958V90M)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERETH-26 (UNII: NNE56F2N14)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LAVENDER OIL (UNII: ZBP1YXW0H8)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
PALMARIA PALMATA (UNII: 7832HOY4ZQ)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
ARTEMISIA UMBELLIFORMIS FLOWER (UNII: 91OLL9AJ7D)
PHOSPHATIDYLCHOLINE, SOYBEAN (UNII: 1T6N4D9YV6)
LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
ROSEMARY OIL (UNII: 8LGU7VM393)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PHENETHYL BENZOATE (UNII: 0C143929GK)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CORN OIL (UNII: 8470G57WFM)
BUDDLEJA DAVIDII LEAF (UNII: X380815D32)
PEUCEDANUM OSTRUTHIUM LEAF (UNII: 86P27YRR6Y)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
APPLE (UNII: B423VGH5S9)
GLYCERIN (UNII: PDC6A3C0OX)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-541-40	44 mL in 1 KIT; Type 1: Convenience Kit of Co-Package	09/17/2020	06/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	06/17/2020	06/01/2024

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

Establishment
Name	Address	ID/FEI	Business Operations
Swiss American CDMO		080170933	manufacture(66738-541)

Revised: 4/2024

Document Id: 16c8e032-d7c9-a617-e063-6394a90a3a15

34390-5

Set id: a84c97df-db4b-14e8-e053-2995a90a8b92

Version: 2

Effective Time: 20240423