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| Product NDC Code | 73088-106 | ||||
|---|---|---|---|---|---|
| Drug Name | (s)undercover spf 50 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | TUBBY TODD | ||||
| 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 Zinc Oxide 12%
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 and as needed. Reapply after 40 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 sun protection measures including: limit time in the sun, especially from 10am-2pm wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENT Allantoin, Bisabolol, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Coco-Caprylate, Helianthus Annuus (Sunflower) Extract, Jojoba Esters, Lecithin, Methylpropanediol, Niacinamide, Nylon-12, Orza Sativa (Rice) Bran Extract, Phenylpropanol, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Propanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Silica, Sodium Chloride, Sodium Hydroxide, Stearalkonium Hectorite, Tetrasodium Glutamate Diacetate, Tocopherol, Tridecyl Salicylate, Water
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 SUNSCREEN
Spl product data elements
Usually a list of ingredients in a drug product.(S)UNDERCOVER SPF 50 ZINC OXIDE ALLANTOIN HYDROLYZED JOJOBA ESTERS SODIUM HYDROXIDE TOCOPHEROL WATER MEDIUM-CHAIN TRIGLYCERIDES ALKYL (C12-15) BENZOATE CAPRYLYL GLYCOL COCO-CAPRYLATE HELIANTHUS ANNUUS WHOLE HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 40-44) LECITHIN, SUNFLOWER PHENYLPROPANOL POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE PROPANEDIOL ROSMARINUS OFFICINALIS WHOLE SILICON DIOXIDE SODIUM CHLORIDE TETRASODIUM GLUTAMATE DIACETATE NYLON-12 RICE BRAN BISABOLOL NIACINAMIDE TRIDECYL SALICYLATE ZINC OXIDE ZINC CATION POLYGLYCERYL-3 PENTARICINOLEATE METHYLPROPANEDIOL STEARALKONIUM HECTORITE POLYGLYCERYL-3 DIISOSTEARATE
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.Sundercover SPF50_Carton Box_R1
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 swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.QUESTIONS (619) 894-6560
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION PROTECT THE PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.
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 ask a doctor if rash occurs.
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