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| Product NDC Code | 84130-006 | ||||||||
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| Drug Name | Sun shield soft glow daily face spf30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Koco Life LLC | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Homosalate 10% Octisalate 5% Octocrylene 4% Avobenzone 3%
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 For Sunscreen use: • Apply generously and evenly 15 minutes before sun exposure. REAPPLY: • At least every 40 minutes 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.• Children under 6 months: Ask doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Isododecane, Dimethicone/Bis-lsobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caprylyl Methicone, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Mica, Titanium Dioxide (Cl 77891), Tocopheryl Acetate, Silica, Tin Oxide, Tocopherol.
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 • If used as directed with other sunprotection measures (see Directions),decreases the risk of skin cancer andearly skin aging caused by the sun
Purpose
Information about the drug product’s indications for use.Purpose Homosalate 10%....................Sunscreen Octisalate 5%........................Sunscreen Octocrylene 4%......................Sunscreen Avobenzone 3%......................Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Sun Shield Soft Glow Daily Face SPF30 Homosalate, Octisalate, Octocrylene, Avobenzone ISODODECANE ALKYL (C12-15) BENZOATE TOCOPHEROL MICA BUTYLOCTYL SALICYLATE DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER SILICON DIOXIDE STANNOUS OXIDE AVOBENZONE AVOBENZONE TITANIUM DIOXIDE .ALPHA.-TOCOPHEROL ACETATE CAPRYLYL TRISILOXANE MEDIUM-CHAIN TRIGLYCERIDES DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE
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.Kopari Sun Shield Soft Glow Daily Face SPF 30 1 2
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 medicalhelp 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 or comments? Call (858) 252-0099
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 doctorif 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 keepout 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 packaging 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 • Do not use on damaged or broken skin • When using this product keepout of eyes • Rinse with water to remove • Stop use and ask a doctorif rash occurs • Keep out of reach of children • If product is swallowed, get medicalhelp or contact a Poison Control Center 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