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| Product NDC Code | 80325-003 | ||||
|---|---|---|---|---|---|
| Drug Name | Ocean safe sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Naturally Uncommon, 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.DRUG FACTS Active Ingredients 8.8% Titanium Dioxide
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 or immediately after towel drying and at least every 2 hours. ■ For children under 6 months of age; ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Deionized Water, Aqueous Extracts of Camellia Sinenis (Green Tea) Leaf*, Ocimum Tenuiflorum (Tulsi) Leaf*, Alaria Esculenta (Wakame Seaweed)*, Olea Europa (Olive) Leaf*, Caprylic/Capric Triglyceride, Aloe Barbadensis (Aloe) Leaf Juice*, Cocoglycerides, Glycerin, Cetearyl Alcohol, Cetyl Palmitate, Polyhydroxystearic Acid, Sorbitan Olivate, Cetearyl Olivate, Methylcellulose, Cocos Nucifera (Coconut) Oil*, Stearic Acid, Acrylates Copolymer, Magnesium Aluminum Silicate, Sorbitan Palmitate, Tocopherol, Xanthan Gum, Alumina, Benzyl Alcohol, Salicylic Acid and Sorbic Acid. *Organic Ingredients. MANUFACTURED FOR NATURALLY UNCOMMON, LLC ATKINSON, NH03811 fishermanhandscrub.com
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.Purpose (Non-Nano)...........Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.OCEAN SAFE SUNSCREEN Titanium Dioxide WATER GREEN TEA LEAF HOLY BASIL LEAF ALARIA ESCULENTA OLEA EUROPAEA LEAF ALOE TRICAPRIN COCO-GLYCERIDES GLYCERIN CETOSTEARYL ALCOHOL CETYL PALMITATE POLYHYDROXYSTEARIC ACID STEARATE SORBITAN OLIVATE CETEARYL OLIVATE METHYLCELLULOSE, UNSPECIFIED COCONUT OIL STEARIC ACID LUVISET 360 MAGNESIUM ALUMINUM SILICATE SORBITAN MONOPALMITATE TOCOPHEROL XANTHAN GUM ALUMINUM OXIDE BENZYL ALCOHOL SALICYLIC ACID SORBIC ACID 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 LABEL.PRINCIPAL DISPLAY PANEL OCEAN SAFE SUNSCREEN-88 ML - NDC-80325-003-01- TUBE LABEL. image description
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.OTHER INFO Protect this product from excessive heat and sunlight.
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 a doctor if rash occurs. ■ When using this product, keep out of eyes. Rinse with water to remove.
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