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| Product NDC Code | 57670-000 | ||||
|---|---|---|---|---|---|
| Drug Name | Restorsea rejuvenating day spf 30 broad spectrum uva uvb with vibransea complex |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 244637 | ||||
| Application Number | M020 | ||||
| Labeler Name | RESTORSEA INC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 20%
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.Providing broad spectrum UVA/UVB protection, Restorsea Rejuvenating Day Lotion SPF 30 protects against damage from environmental factors and helps reduce the appearance of fine lines and wrinkles. Apply in morning either over Restorsea Rejuvenating Day Cream or directly to clean skin. No Parabens. No phthalates. No PEGs. No mineral oil. Hypoallergenic. Clinically tested. Dermatologist tested. Non-comedogenic. Store in a cool, dry place.
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. 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 broad spectrum SPF 15 or higher and other sun protection measures including: Limit time in the sun especially from 10 am - 2 pm Wear long sleeve shirts, pants, hats and sunglasses Reapply at least every two hours. Use a water resistant sunscreen if swimming or sweating. Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Dicaprylyl Ether, Glycerin, Cetearyl Olivate, Sorbitan Olivate, Hydrolyzed Roe, Ascorbyl Glucoside, Alaria Esculenta Extract, Algin, Caprylic/Capric Triglyceride, Citric Acid, Fragrance, Glyceryl Caprylate, Glyceryl Undecylenate, Honeysuckle Flower Extract, Honeysuckle Extract, Microcrystalline Cellulose, Sodium Citrate, Triethoxycapryl silane, Xanthan Gum
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.restorsea Rejuvenating Day SPF 30 Broad Spectrum UVA UVB with Vibransea Complex ZINC OXIDE WATER DICAPRYLYL ETHER GLYCERIN CETEARYL OLIVATE SORBITAN OLIVATE ASCORBYL GLUCOSIDE ALARIA ESCULENTA MEDIUM-CHAIN TRIGLYCERIDES CITRIC ACID MONOHYDRATE GLYCERYL CAPRYLATE LONICERA CAPRIFOLIUM FLOWER CELLULOSE, MICROCRYSTALLINE SODIUM CITRATE TRIETHOXYCAPRYLYLSILANE XANTHAN GUM ZINC OXIDE ZINC OXIDE
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.restorsea Rejuvenating Day Lotion SPF 30 Broad Spectrum UVA/UVB with Vibransea Complex net wt. 1.7 oz / 50g www.restorsea.com RESTORSEA LLC, DIST. NEW YORK, NY 10022 MADE IN USA PATENT PENDING TM
restorsea Rejuvenating Day Lotion SPF 30 Broad Spectrum UVA/UVB with Vibransea Complex 1.7oz/50g (57670-000-00) Restorsea 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.restorsea Rejuvenating Day Lotion SPF 30 Broad Spectrum UVA/UVB with Vibransea Complex
Other Information Protect the product in this container from excessive heat and direct sun.
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 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 or comments? Call 888-785-8878 Monday through Friday 9 am - 5pm US EST
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.
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 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. Keep out of reach of children. If product is 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