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| Product NDC Code | 69435-1401 | ||||
|---|---|---|---|---|---|
| Drug Name | Fre glow me lightweight tinted moisturizer light medium |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Peer Pharm Ltd. | ||||
| 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 Zinc Oxide 19.2% Purpose 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 Shake well before use. Apply liberally 15 minutes before sun exposure • Reapply: • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • 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 am to 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses • Children under 6 months: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water (Aqua), Coco-Caprylate, Glyceryl Oleate Citrate, Stearyl Octyldodecyl Citrate Crosspolymer, Lauryl Glucoside, Xanthan Gum,Panthenol, Argania Spinosa Kernel Oil, Polyglyceryl-6 Laurate,Propanediol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Isomalt,Caprylic/Capric Triglyceride, Glycerin, Myristyl Glucoside, Caprylyl Glycol, Sodium Phytate, Lauroyl Lysine, Argania Spinosa Leaf Extract,Caprylhydroxamic Acid, Tocopherol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Cymbopogon, Flexuosus Oil, Lavandula Angustifolia (Lavender) Oil, Carnosine, Argania Spinosa Callus Culture Extract, Lecithin, Titanium Dioxide, Iron Oxide Yellow (CI 77492), Iron Oxide Red (CI 77491), Iron Oxide Black (CI 77499).
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 sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun.
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.Fre Glow Me Lightweight Tinted Moisturizer Light Medium ZINC OXIDE WATER COCO-CAPRYLATE GLYCERYL MONOOLEATE CITRATE STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER LAURYL GLUCOSIDE XANTHAN GUM PANTHENOL PROPANEDIOL POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHOXYCAPRYLYLSILANE ISOMALT MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN MYRISTYL GLUCOSIDE CAPRYLYL GLYCOL PHYTATE SODIUM LAUROYL LYSINE ARGANIA SPINOSA LEAF CAPRYLHYDROXAMIC ACID TOCOPHEROL BERGAMOT OIL EAST INDIAN LEMONGRASS OIL LAVENDER OIL CARNOSINE ARGAN OIL LECITHIN, SOYBEAN TITANIUM DIOXIDE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE ZINC OXIDE ZINC OXIDE
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.Product label image description
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Other information Protect the product in this container from excessive heat and direct sun. Do not use if the seal is broken.
Questions or Comments Call 951-297-7976 or visit www.kcare.co.il
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, call a Poison Control Center or get medical help right away.
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 , Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs Keep out of reach of children. If swallowed, call a Poison Control Center or get medical help 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