Label: JACK BLACK THE CLOSER- avobezone, octinoxate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 66738-421-40 - Packager: Jack Black L.L.C
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 6, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Use
- Warnings
- DO NOT USE
- STOP USE
- WHEN USING
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
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INGREDIENTS AND APPEARANCE
JACK BLACK THE CLOSER
avobezone, octinoxate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66738-421 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 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 Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66738-421-40 44 mL in 1 NOT APPLICABLE; Type 1: Convenience Kit of Co-Package 09/17/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 09/17/2020 Labeler - Jack Black L.L.C (847024036) Establishment Name Address ID/FEI Business Operations Swiss American CDMO 080170933 manufacture(66738-421) , label(66738-421)
