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| Product NDC Code | 70605-028 | ||||
|---|---|---|---|---|---|
| Drug Name | Principal secret reclaim oil control hydrator spf-8 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Guthy-Renker 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.Active ingredient Titanium Dioxide 4.0%
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. Use a water-resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Caprylic/Capric Triglyceride, Dimethicone, Tapioca Starch Polymethylsilsesquioxane, Butylene Glycol, Methyl Glucose Sesquistearate, PEG-20 Methyl Glucose Sesquistearate, Polysorbate 20, Squalane, Polyacrylate-13, Sorbitan Isostearate, Di-PPG-3 Myristyl Ether Adipate, Acetyl Hexapeptide-8, Sodium Hyaluronate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Retinyl Palmitate, Glucosamine HCl, Pisum Sativum (Pea) Extract, Bambusa Vulgaris Leaf/Stem Extract, Laminaria Saccharina Extract, Ahnfeltia Concinna Extract, Camellia Oleifera Leaf Extract, Camellia Sinensis Leaf Extract, Vitis Vinifera (Grape) Seed Extract, Cucumis Melo (Melon) Fruit Extract, Glycosaminoglycans, Hydrolyzed Prunus Domestica, Zinc PCA, Glycerin, Xanthan Gum, Polyisobutene, Sodium Myristol Sarcosinate, Tetrasodium EDTA, Ethylhexylglycerin, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Phenoxyethanol
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 Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Principal Secret Reclaim Oil Control hydrator SPF-8 Titanium Dioxide Titanium Dioxide Titanium Dioxide Water MEDIUM-CHAIN TRIGLYCERIDES Dimethicone Butylene Glycol Methyl Glucose Sesquistearate PEG-20 METHYL GLUCOSE SESQUISTEARATE Polysorbate 20 Squalane POLYACRYLAMIDE (1500 MW) Sorbitan Isostearate Di-PPG-3 Myristyl Ether Adipate Acetyl Hexapeptide-8 HYALURONATE SODIUM Tetrahexyldecyl Ascorbate .ALPHA.-TOCOPHEROL ACETATE VITAMIN A PALMITATE GLUCOSAMINE HYDROCHLORIDE PEA BAMBUSA VULGARIS TOP SACCHARINA LATISSIMA AHNFELTIOPSIS CONCINNA CAMELLIA OLEIFERA LEAF GREEN TEA LEAF VITIS VINIFERA SEED MUSKMELON ZINC PIDOLATE Glycerin Xanthan Gum POLYISOBUTYLENE (1000 MW) SODIUM MYRISTOYL SARCOSINATE EDETATE SODIUM Ethylhexylglycerin Hexylene Glycol Caprylyl Glycol Potassium Sorbate Phenoxyethanol
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 - 50 mL Bottle Label PRINCIPAL SECRET ® RECLAIM ® with Argireline ® Oil Control Hydrator SPF 8 Oil-Free Moisturizer 1.7 FL. Oz. / 50 ml PRINCIPAL DISPLAY PANEL - 50 mL Bottle 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.Drug Fact Label
Distributed by Guthy-Renker® • Palm Desert, CA 92260 USA
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? Within US 1-800-510-4961
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect this product 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 Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn not skin cancer or early skin aging. 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. 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