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Product NDC Code | 66738-304 | ||||||
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Drug Name | Jack black sun guard sunscreen spf45 |
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Type | Brand | ||||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | LOTION | ||||||
Application Number | M020 | ||||||
Labeler Name | Jack Black, LLC | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Octisalate 3.0% Sunscreen Octinoxate 7.5% Sunscreen Zinc Oxide 8.0% Sunscreen
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 Reapply: after 80 minutes of swimming or sweating Immediately after towel drying At least every two hours Children under 6 months: ask a doctor 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 SFP value of 15 or higher Limit time in the sun, eespecially from 10 a.m. - 2 p.m.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Artemisia Umbelliformis Extract, Ascorbyl Palmitate, Buddleja Davidii Leaf Extract, Butylene Glycol, Calendula Officinalis Flower Extract, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexyl Isononanoate, Glycerin, Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxethyl Dimethicone, Leontopodium Aloinum (Edelweiss) Extract, Penoxyethanol, Peucedanum Ostruthium Leaf Extract, Retinyl Palmitate, Sodium Chloride, Triethoxycaprylylsilane, Water
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.Uses Helps prevent sunburn
Purpose
Information about the drug product’s indications for use.Uses Helps prevent sunburn
Spl product data elements
Usually a list of ingredients in a drug product.Jack Black Sun Guard Sunscreen SPF45 Sunscreen OCTISALATE OCTISALATE OCTINOXATE OCTINOXATE ZINC OXIDE ZINC CATION BUTYLENE GLYCOL PHENOXYETHANOL IODOPROPYNYL BUTYLCARBAMATE WATER SODIUM CHLORIDE VITAMIN A PALMITATE ASCORBYL PALMITATE CALENDULA OFFICINALIS FLOWER LEONTOPODIUM ALPINUM FLOWER PEUCEDANUM OSTRUTHIUM LEAF BUDDLEJA DAVIDII LEAF ARTEMISIA UMBELLIFORMIS FLOWER CYCLOMETHICONE 5 DIMETHICONE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE ETHYLHEXYL ISONONANOATE TRIETHOXYCAPRYLYLSILANE GLYCERIN off-white
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.Labeling Sun Guard Artwork
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 KEEP OUT OF REACH OF CHILDREN
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information Protect product from exessive heat and direct sunlight. You may report a serious adverse reaction from using this product to Jack Black at 1-877-766-3388
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
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 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 Cneter right away
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