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Jack black shave essentials - Medication Information

Product NDC Code 66738-541
Drug Name

Jack black shave essentials

Type Brand
Active Ingredients
Avobenzone 2.2 g/100ml
Octinoxate 7.5 g/100ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Jack Black L.L.C.
Packages
Package NDC Code Description
66738-541-40 44 ml in 1 kit (66738-541-40)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Avobenzone 2.2%, Octinoxate 7.5%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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 ingredient

A list of inactive, non-medicinal ingredients in a drug product.
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

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use Moisturizes and helps prevent sunburn.

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
JACK BLACK SHAVE ESSENTIALS AVOBENZONE, OCTINOXATE HASLEA OSTREARIA MELISSA OFFICINALIS ALCOHOL CHAMAEMELUM NOBILE FLOWER OIL OCTINOXATE OCTINOXATE DIMETHICONE GLYCERETH-26 CYCLOMETHICONE 5 HYALURONATE SODIUM LAVENDER OIL AVOBENZONE AVOBENZONE WATER PHENOXYETHANOL EDETATE DISODIUM ANHYDROUS SORBITAN ISOSTEARATE PALMARIA PALMATA CETEARYL GLUCOSIDE ARTEMISIA UMBELLIFORMIS FLOWER PHOSPHATIDYLCHOLINE, SOYBEAN LEONTOPODIUM ALPINUM FLOWERING TOP ROSEMARY OIL LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE PELARGONIUM GRAVEOLENS FLOWER OIL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE OCTYLDODECYL NEOPENTANOATE PHENETHYL BENZOATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) HYDROXYPROPYL DISTARCH PHOSPHATE, HIGH AMYLOSE CORN VITAMIN A PALMITATE CALENDULA OFFICINALIS FLOWER .ALPHA.-TOCOPHEROL ACETATE POLYSORBATE 60 CORN OIL BUDDLEJA DAVIDII LEAF PEUCEDANUM OSTRUTHIUM LEAF SODIUM HYDROXIDE BUTYLENE GLYCOL APPLE GLYCERIN IODOPROPYNYL BUTYLCARBAMATE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Jack Black Double Duty

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on damaged or broken skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If swallowed , get medical help or contact Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? 1-877-766-3388 www.getjackblack.com

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask doctor if rash occurs

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
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.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings For external use only

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API