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Product NDC Code | 65435-0100 | ||||||||
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Drug Name | Safe sea spf 50 |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LOTION | ||||||||
Application Number | M020 | ||||||||
Labeler Name | NIDARIA TECHNOLOGY LTD | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.: Active Ingredients Octocrylene 10% Homosalate 10% Octisalate 5% Avobenzone 3% : Sunscreen Purpose
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.: Aqua, Dibutyl Adipate, Polyglyceryl 2 Dipolyhydroxystearate, Stearyl Dimethicone, Cetyl Dimethicone, Magnesium Stearate, Hydrogenated Castor Oil, Benzyl alcohol, Lanthanum Chloride, Magnesium Chloride, Calcium Chloride, Glycosaminoglycans, Glycoproteins, Plankton Extract, Parfum(Fragrance), Chlorphenisin, Panthenol, Tocopheryl Acetate, Dehydroacetic Acid, Benzoic Acid, Sorbic Acid Inactive Ingredients
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.: ■ 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. Uses
Spl product data elements
Usually a list of ingredients in a drug product.Safe Sea SPF 50 Homosalate, Octocrylene, Octisalate, Avobenzone WATER DIBUTYL ADIPATE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE STEARYL DIMETHICONE (400 MPA.S AT 50C) CETYL DIMETHICONE 25 PROPYLENE GLYCOL HYDROGENATED CASTOR OIL BENZYL ALCOHOL LANTHANUM CHLORIDE MAGNESIUM CHLORIDE CALCIUM CHLORIDE CHLORPHENESIN PANTHENOL .ALPHA.-TOCOPHEROL ACETATE DEHYDROACETIC ACID BENZOIC ACID SORBIC ACID PHAEODACTYLUM TRICORNUTUM SACCHAROMYCES CEREVISIAE POLYSULFATED GLYCOSAMINOGLYCAN OCTOCRYLENE OCTOCRYLENE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE
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.Principal display panel Front Label Back Label Front Back
Instructions for use
Information about safe handling and use of the drug product.: ■ Apply liberally 15 minutes before sun exposure ■ reapply: After 80 minutes of swimming or sweating, immediately after towel drying and 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 of 15 or higher and other sun protection measures including: ■ Limit time in the sun, especially from 10 a.m.to 2 p.m.■ Wear long-sleeve shirts, pants, hats, and sunglasses ■ Children under 6 months: Ask a doctor. Directions
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.. If product is swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.: ■ Give particular attention to coverage of arms and legs. ■ In water infested by Sea Lice, Safe Sea should also be applied under the bathing suit.■ Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water, nor is it a guarantee against stings.■ In case of sting do not use Safe Sea as a treatment - seek medical attention.*Tested against Sea nettle (Chrysaora), Atlantic Box jellyfish (Chiropsalmus) & Rhopilema. Data on file. ■ Protect this product from excessive heat and direct sun. Other Information
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? [email protected]
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.: ■ ■ 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 Warning For external use only
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