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Jack black - Medication Information

Product NDC Code 66738-502
Drug Name

Jack black

Type Brand
Active Ingredients
Titanium dioxide 3.9 g/100ml
Zinc oxide 3.2 g/100ml
Route TOPICAL
Dosage Form LOTION
Application Number M020
Labeler Name Jack Black L.L.C
Packages
Package NDC Code Description
66738-502-01 1 tube in 1 carton (66738-502-01) / 59 ml in 1 tube (66738-502-22)
66738-502-21 14 ml in 1 packet (66738-502-21)
Check if available Online

Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Titanium Dioxide 3.9% Zinc Oxide 3.2%

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 • Children under 6 months of age: Ask a doctor • Reapply at least every 2 hours • Use a water-resistant sunscreen if swimming or sweating • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • 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 Water, Caprylic/Capric Triglyceride, Glycerin, Butyloctyl Salicylate, Propanediol, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Silica, Azelaic Acid, Allantoin, Sodium Hyaluronate, Camellia Sinensis Leaf Extract*, Vaccinium Macrocarpon (Cranberry) Fruit Extract*, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Niacinamide, Oryza Sativa (Rice) Extract, Alumina, Isohexadecane, Hydrogenated Lecithin, Polyhydroxystearic Acid, Xylitol, Stearic Acid, Polysorbate 60, Triethoxycaprylylsilane, Xanthan Gum, Aminomethyl Propanol, Sorbitan Isostearate, Hydrogenated Phosphatidylcholine, Citric Acid, Phenoxyethanol. 24012 *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 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 Titanium Dioxide, Zinc Oxide DECAMETHYLTETRASILOXANE HYDROGENATED SOYBEAN LECITHIN HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) ROSEMARY WATER ALUMINUM OXIDE NIACINAMIDE AZELAIC ACID MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN PROPANEDIOL SORBITAN ISOSTEARATE HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINE ANHYDROUS CITRIC ACID XANTHAN GUM XYLITOL AMINOMETHYLPROPANOL SILICON DIOXIDE PHENOXYETHANOL TRIETHOXYCAPRYLYLSILANE HYALURONATE SODIUM TITANIUM DIOXIDE TITANIUM DIOXIDE POLYHYDROXYSTEARIC ACID (2300 MW) PEG-60 SORBITAN STEARATE GREEN TEA LEAF ZINC OXIDE ZINC OXIDE RICE GERM ALLANTOIN BUTYLOCTYL SALICYLATE ISOHEXADECANE CRANBERRY STEARIC ACID

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.
Principal Display Panel Jack Black Authentic and Original Dual Defense Face Moisturizer 100% Mineral Sunscreen Broad Spectrum SPF 30 with Hyaluronic Acid & Niacinamide SPF 30 59 mL / 2 FL OZ Jack Black Authentic and Original Dual Defense Face Moisturizer 100% Mineral Sunscreen Broad Spectrum SPF 30 with Hyaluronic Acid & Niacinamide SPF 30 59 mL / 2 FL OZ Jack Black Authentic and Original Dual Defense Face Moisturizer 100% Mineral Sunscreen Broad Spectrum SPF 30 with Hyaluronic Acid & Niacinamide SPF 30 15 mL / 0.5 FL OZ Tube Carton Packet

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 product is swallowed, get medical help or contact a 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? www.getJackBlack.com 1-877-766-3388; 1-469-341-2700

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 a 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 the product in this container from excessive heat and direct sun

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