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Product NDC Code | 66738-501 | ||||
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Drug Name | Jack black dual defense face moisturizer - spf 30 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | Jack Black L.L.C | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients 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, Azelaic Acid, Allantoin, Sodium Hyaluronate, Camellia Sinensis Leaf Extract*, Rosmarinus Officinalis (Rosemary) Leaf Extract*, Vaccinium Macrocarpon (Cranberry) Fruit Extract*, Silica, Alumina, Isohexadecane, Hydrogenated Lecithin, Polyhydroxystearic Acid, Xylitol, Stearic Acid, Niacinamide, Polysorbate 60, Oryza Sativa (Rice) Extract, Triethoxycaprylylsilane, Xanthan Gum, Aminomethyl Propanol, Sorbitan Isostearate, Hydrogenated Phosphatidylcholine, Methicone, Citric Acid, Phenoxyethanol. 21002 *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 Dual Defense Face Moisturizer - SPF 30 Titanium Dioxide, Zinc Oxide SILICON DIOXIDE WATER PROPANEDIOL HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) ALUMINUM OXIDE HYDROGENATED SOYBEAN LECITHIN POLYHYDROXYSTEARIC ACID (2300 MW) RICE GERM HYDROGENATED SOYBEAN PHOSPHATIDYLCHOLINE CRANBERRY CITRIC ACID MONOHYDRATE PHENOXYETHANOL ROSEMARY AMINOMETHYLPROPANOL GREEN TEA LEAF GLYCERIN BUTYLOCTYL SALICYLATE DIMETHICONE ISOHEXADECANE TRIETHOXYCAPRYLYLSILANE NIACINAMIDE TITANIUM DIOXIDE TITANIUM DIOXIDE XYLITOL STEARIC ACID XANTHAN GUM AZELAIC ACID ALLANTOIN METHICONE (20 CST) POLYSORBATE 60 HYALURONATE SODIUM SORBITAN ISOSTEARATE ZINC OXIDE ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES
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.Dual Defense 09-2050-01 2 oz tube Dual Defense Carton 2 oz
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