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| Product NDC Code | 73563-638 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Orior spf 30 mineral sunscreen |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | CUTANEOUS | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | part352 | ||||||
| Labeler Name | Body One, 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 Zinc Oxide 21.6%
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 and evenly 15 minutes before sun exposure. * 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua/water, ButylOctyl Salicylate, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Disteardimmonium Hectorite, EthylHexylglycerin, EthylhexylMethoxycrylene, Fragrance, Glycerine, Isostearic Acid, Lecithin, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-3 Diisostearate, Polyglyceryl-2 Dipolyhydroxystearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid.
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. * higher SPF five more sunburn protection * retains SPF after 40 minutes of activity in the water * If used as directed with other sun protection measures, 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.Hilton SPF 30 Mineral Sunscreen Zinc Oxide ZINC OXIDE ZINC OXIDE WATER MAGNESIUM SULFATE, UNSPECIFIED FORM GLYCERIN PHENOXYETHANOL GUAIETOLIN, (S)- POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE BUTYLOCTYL SALICYLATE C13-15 Alkane MEDIUM-CHAIN TRIGLYCERIDES ALKYL (C12-15) BENZOATE ETHYLHEXYL METHOXYCRYLENE POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-3 PENTARICINOLEATE ISOSTEARIC ACID HYDROGENATED SOYBEAN LECITHIN DISTEARDIMONIUM HECTORITE LINALYL ACETATE PHENYLETHYL ALCOHOL ETHYL LINALOOL TETRAHYDROLINALOOL Orior SPF 30 Mineral Sunscreen Zinc Oxide ZINC OXIDE ZINC OXIDE WATER MAGNESIUM SULFATE, UNSPECIFIED FORM GLYCERIN PHENOXYETHANOL GUAIETOLIN, (S)- POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE BUTYLOCTYL SALICYLATE C13-15 Alkane MEDIUM-CHAIN TRIGLYCERIDES ALKYL (C12-15) BENZOATE ETHYLHEXYL METHOXYCRYLENE POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-3 PENTARICINOLEATE ISOSTEARIC ACID HYDROGENATED SOYBEAN LECITHIN DISTEARDIMONIUM HECTORITE LINALYL ACETATE PHENYLETHYL ALCOHOL ETHYL LINALOOL TETRAHYDROLINALOOL
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 - 59 ml. Bottle Label Hilton WAIKOLOA VILLAGE ® MINERAL SUNSCREEN SPF 30 BROAD SPECTRUM 2 fl. oz. (59 ml.) www.hiltonwaikoloavillage.com Principal Display Panel - 59 ml. Bottle Label
PRINCIPAL DISPLAY PANEL - 150 mL Bottle Label ORIOR MINERAL SUNSCREEN LOTION SPF 30 BROAD SPECTRUM 5.0 fl.oz. 150 mL Principal Display Panel - 150 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 Facts
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 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? 1-833-263-9663
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 removed. Stop use and ask a doctor if rash of irritation develops and lasts.
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 help prevent sunburn, not skin cancer of early skin aging. For External Use Only Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to removed. Stop use and ask a doctor if rash of irritation develops and lasts. Keep out of reach of Children. 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