JACK BLACK THE CLOSER- avobezone, octinoxate lotion 
Jack Black L.L.C

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Double Duty

JACK BLACK THE CLOSER 
avobezone, octinoxate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66738-421
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PHOSPHATIDYLCHOLINE, SOYBEAN (UNII: 1T6N4D9YV6)  
MELISSA OFFICINALIS (UNII: YF70189L0N)  
ALCOHOL (UNII: 3K9958V90M)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN (UNII: 9F8ET54T05)  
GLYCERIN (UNII: PDC6A3C0OX)  
BUDDLEJA DAVIDII LEAF (UNII: X380815D32)  
PEUCEDANUM OSTRUTHIUM LEAF (UNII: 86P27YRR6Y)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
PHENETHYL BENZOATE (UNII: 0C143929GK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CORN OIL (UNII: 8470G57WFM)  
HASLEA OSTREARIA (UNII: Y87200QHN9)  
CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERETH-26 (UNII: NNE56F2N14)  
APPLE (UNII: B423VGH5S9)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
ARTEMISIA UMBELLIFORMIS FLOWER (UNII: 91OLL9AJ7D)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
LEONTOPODIUM ALPINUM FLOWERING TOP (UNII: QQC1AK06RK)  
PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PALMARIA PALMATA (UNII: 7832HOY4ZQ)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66738-421-4044 mL in 1 NOT APPLICABLE; Type 1: Convenience Kit of Co-Package09/17/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35209/17/2020
Labeler - Jack Black L.L.C (847024036)
Establishment
NameAddressID/FEIBusiness Operations
Swiss American CDMO080170933manufacture(66738-421) , label(66738-421)

Revised: 7/2021
Document Id: af88b74b-286b-c8d6-e053-2995a90af656
Set id: af88b74b-286a-c8d6-e053-2995a90af656
Version: 1
Effective Time: 20210706
 
Jack Black L.L.C