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| Product NDC Code | 73691-296 | ||||
|---|---|---|---|---|---|
| Drug Name | Outer reef reef safe (wr) broad spectrum spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Coral Reef Park Co., 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 Ingredient Titanium Dioxide 8.00% 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: Apply liberally 15-minutes before sun exposure. Children under 6-months of age: ask a doctor. Reapply: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscren with broad spectrum SPF of 15 or higher and other sun protection measures Sun Protection Measures: -after 80 minutes of swimming or sweating -immediately after towel drying -at least every 2 hours -Limit time in the sun, especially between 10am and 2pm. -Wear long sleeve shirts, pants, hats and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Aloe Barbadensis Leaf (Aloe Vera gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, *Camellia Sinenesis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Palmitate, Citrullus Lanatus (Watermelon) Extract, *Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, *Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, *Helianthus Annuus (Sunflower) Oil, Hydrogenated Castor Oil, Hydroxymethylcellulose, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Silica, Sorbitan Olivate, Stearic Acid, Tocopherol (Vitamin E), Tridecyl Salicylate, xanthan gum, triethoxycaprylylsilane. *Denotes certified organic ingredient.
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 Higher SPF gives more sunburn protection Retains SPF after 80 minutes of swimming or sweating If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. directions
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.OUTER REEF Reef Safe (WR) Broad Spectrum SPF 30 TITANIUM DIOXIDE ALOE VERA LEAF WATER BUTYLOCTYL SALICYLATE GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CETEARYL OLIVATE CETYL PALMITATE WATERMELON COCONUT OIL CARROT DODECANE GLYCERIN GLYCERYL CAPRYLATE GLYCERYL MONOSTEARATE HELIANTHUS ANNUUS FLOWERING TOP HYDROGENATED CASTOR OIL HYDROXYMETHYL CELLULOSE MAGNESIUM ALUMINUM SILICATE SILICON DIOXIDE SORBITAN OLIVATE STEARIC ACID TOCOPHEROL TRIDECYL SALICYLATE XANTHAN GUM TRIETHOXYCAPRYLYLSILANE TITANIUM DIOXIDE TITANIUM DIOXIDE
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.Package Labeling: Label
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 this product from excessive heat and direct sunlight.
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 attention or contact poisin control center immediately.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Comments & Suggestions: [email protected]
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 consult physician if irritation or rash develops.
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.
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 not intended for ingestion. 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 poisin 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