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| Product NDC Code | 76348-598 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Impact melanoma spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | part352 | ||||||||
| Labeler Name | RENU LABORATORIES, INC. | ||||||||
| 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 Octyl Methoxy Cinnamate 7.00% Sunscreen Titanium Dioxide 1.25% Sunscreen Zinc Oxide 1.25% Sunscreen Octyl Salicylate 1.00% 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. reapply immediately after towel drying. Reapply 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 sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Limited time in the sun, especially between 10am and 2pm. Wear long sleeve shirts, pants, hats and sunglasses. For children under 6 months, consult a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.OTHER INGREDIENTS Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, Carbopol, Ceteareth-20, Cetearyl Alcohol, Deionized Water, Dimethicone, Glycerin, Hexylene Glycol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol, Polyester-7, Neopentyl Glycol, Diheptanoate, Sorbitol, Stearic Acid, Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine, Tocopheryl Acetate (Vitamin E)
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 Octyl Methoxy Cinnamate 7.00% Sunscreen Titanium Dioxide 1.25% Sunscreen Zinc Oxide 1.25% Sunscreen Octyl Salicylate 1.00% Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Impact Melanoma SPF 30 ZINC OXIDE ASIAN GINSENG MALVA SYLVESTRIS FLOWER GLYCERIN MATRICARIA RECUTITA FLOWERING TOP COMFREY LEAF ZINC OXIDE ZINC OXIDE SORBITOL POLYOXYL 20 CETOSTEARYL ETHER CETOSTEARYL ALCOHOL DIMETHICONE 350 CETYL ALCOHOL OCTINOXATE OCTINOXATE OCTISALATE OCTISALATE CARBOMER 934 WATER ISOCETYL STEARATE ALPHA-TOCOPHEROL ACETATE TROLAMINE ALOE VERA LEAF POLYESTER-7 NEOPENTYL GLYCOL DIHEPTANOATE CAPRYLYL GLYCOL PHENOXYETHANOL HEXYLENE GLYCOL TITANIUM DIOXIDE TITANIUM DIOXIDE STEARIC ACID CALENDULA OFFICINALIS FLOWER
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.LABEL FOR IMPACT MELANOMA SPF Impact SPF LABEL
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Minor word changes in Administration such as apply liberally rather than apply generously No Major changes in Uses section
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect this product from excessive heat and direct sunlight. May stain some fabrics.
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? Visit www.BrightGuard.com or call (310) 589-4116
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 consult physician if irritation or rash develops. Keep out of reach of children. If product is swallowed, get medical attention or contact poison control center immediately.
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