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| Product NDC Code | 84271-001 | ||||
|---|---|---|---|---|---|
| Drug Name | Seytu body sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Omnilife USA, 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.A ctive I ngredients Titanium Dioxide 8.3% Zinc Oxide 4.875%
| Titanium Dioxide | 8.3% |
| Zinc Oxide | 4.875% |
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 generously 15 minutes before sun exposure. Apply to all skin exposed to the sun. Children under 6 months of age: Ask a doctor. 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 sub and other sun protection measures including: Limit time in the sun, especially from 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats and sunglasses. Reapply: ⦁ after 80 minutes of swimming or sweating. ⦁ Immediately after towel drying ⦁ at least every 2 hours.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aluminum Hydroxide, Aluminum Starch Octenylsuccinate, Aqua (Water), Benzotriazolyl Dodecyl p-Cresol, Benzyl alcohol, Bisabolol, Butyrospermum Parkii (Shea) Butter, Cetyl PEG/PPG-10/1 Dimethicone, Dicaprylyl Carbonate, Dimethicone/Vinyl Dimethicone Crosspolymer, Glycerin, Glyceryl Caprylate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Ethylhexyl Olivate, Hydrogenated Farnesene, Hydrogenated Olive Oil Unsaponifiables, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxystearic Acid, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Chloride, Stearic Acid, Tocopherol, Triethoxycaprylylsilane.
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.P urpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.SEYTU Body Sunscreen titanium dioxide and zinc oxide TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER DICAPRYLYL CARBONATE HYDROGENATED OLIVE OIL GLYCERIN FARNESENE SODIUM CHLORIDE POLYHYDROXYSTEARIC ACID (2300 MW) BENZOTRIAZOLYL DODECYL P-CRESOL ALUMINUM STARCH OCTENYLSUCCINATE ALUMINUM HYDROXIDE CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) STEARIC ACID SUNFLOWER OIL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) JOJOBA OIL BENZYL ALCOHOL HYDROGENATED OLIVE OIL UNSAPONIFIABLES GLYCERYL CAPRYLATE SHEA BUTTER LEVOMENOL GLYCERYL 1-UNDECYLENATE GLYCERYL 2-UNDECYLENATE TRIETHOXYCAPRYLYLSILANE TOCOPHEROL PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
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 SEYTÚ SPF 50+ 50+UVA UVB HIGH SUN PROTECTION Body Sunscreen 80 min. Water-resistant OCEAN RESPECT REEF SAFE Net Wt. 4.05 fl. oz. (120 ml) PRINCIPAL DISPLAY PANEL SEYTÚ SPF 50+ 50+UVA UVB HIGH SUN PROTECTION Body Sunscreen 80 min. Water-resistant OCEAN RESPECT REEF SAFE Net Wt. 4.05 fl. oz. (120 ml)
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.SEYTÚ BODY SUNSCREEN SPF 5 0 + - titanium dioxide, zinc oxide crea m Drug Facts
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 .
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect the product in this container from excessive heat and direct sun.
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 ask a doctor if rash occurs.
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. If swallowed, get medical help, or contact a Poison Control Center 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