JACK BLACK THE TRIPLE PLAY- avobenzone, octinoxate lotion

JACK BLACK THE TRIPLE PLAY by

Drug Labeling and Warnings

JACK BLACK THE TRIPLE PLAY 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]

Active Ingredients

Avobenzone 2.2%

Octinoxate 7.5%

Purpose

Sunscreen

Use

Moisturizes and helps prevent sunburn

Warnings

For external use only.

DO NOT USE

Do not use on damaged or broken skin.

STOP USE

Stop use and ask doctor if rash occurs.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

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

Directions

Apply liberally after cleansing and shaving and 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, use sunscreen with a broad spectrum SPF 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

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

JACK BLACK THE TRIPLE PLAY 
avobenzone, octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66738-661
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
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENETHYL BENZOATE (UNII: 0C143929GK)
PALMARIA PALMATA (UNII: 7832HOY4ZQ)
GLYCERIN (UNII: PDC6A3C0OX)
ROSEMARY OIL (UNII: 8LGU7VM393)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CORN OIL (UNII: 8470G57WFM)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
POLYSORBATE 60 (UNII: CAL22UVI4M)
GLYCERETH-26 (UNII: NNE56F2N14)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ALCOHOL (UNII: 3K9958V90M)
DIMETHICONE (UNII: 92RU3N3Y1O)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
MELISSA OFFICINALIS (UNII: YF70189L0N)
LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)
BUDDLEJA DAVIDII LEAF (UNII: X380815D32)
HASLEA OSTREARIA (UNII: Y87200QHN9)
APPLE (UNII: B423VGH5S9)
ARTEMISIA UMBELLIFORMIS FLOWER (UNII: 91OLL9AJ7D)
PHOSPHATIDYLCHOLINE, SOYBEAN (UNII: 1T6N4D9YV6)
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEUCEDANUM OSTRUTHIUM LEAF (UNII: 86P27YRR6Y)
WATER (UNII: 059QF0KO0R)
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)
LAVENDER OIL (UNII: ZBP1YXW0H8)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66738-661-40	44 mL in 1 KIT; Type 1: Convenience Kit of Co-Package	09/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	09/30/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Swiss American CDMO		080170933	manufacture(66738-661)