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| Product NDC Code | 73496-011 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Roc barrier renew am moisturizer spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | RoC Skincare | ||||||||
| 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 Active ingredients Purpose Avobenzone 2.0%, Homosalate 5.5%, Octisalate 4.5%, Octocrylene 4.0% Sunscreen
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 for Sunscreen Use Directions For Sunscreen use: Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Inactive ingredients Water/Aqua/Eau, Butylene Glycol, Octyldodecyl Neopentanoate, C14-22 Alcohols, Isododecane, Glycerin, Squalane, Sorbitan Isostearate, Beta-Sitosterol, Astragalus Membranaceus Root Extract, Butyrospermum Parkii (Shea) Butter, Oleic Acid, Ceramide NG, Ceramide NP, Withania Somnifera Root Extract, Glyceryl Behenate, Alteromonas Ferment Extract, Polyglyceryl-4 Isostearate, Biosaccharide Gum-4, Camellia Sinensis Leaf Extract, Euphorbia Cerifera (Candelilla) Wax, Lecithin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, C12-20 Alkyl Glucoside, Polyisobutene, PEG-7 Trimethylolpropane Coconut Ether, Tocopherol, Ethylhexylglycerin, 1,2-Hexanediol, 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.Indications and Usage 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.Uses Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early signs of aging caused by the sun
Spl product data elements
Usually a list of ingredients in a drug product.RoC Barrier Renew AM Moisturizer SPF 30 Avobenzone, Homosalate, Octisalate, Octocrylene SHEA BUTTER WITHANIA SOMNIFERA ROOT BIOSACCHARIDE GUM-4 CANDELILLA WAX AVOBENZONE AVOBENZONE BUTYLENE GLYCOL ASTRAGALUS MONGHOLICUS ROOT OLEIC ACID 1,2-HEXANEDIOL TOCOPHEROL OCTOCRYLENE OCTOCRYLENE ISODODECANE GLYCERIN POLYGLYCERYL-4 ISOSTEARATE C12-20 ALKYL GLUCOSIDE ETHYLHEXYLGLYCERIN GLYCERYL MONOBEHENATE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE WATER C14-22 ALCOHOLS GREEN TEA LEAF PEG-7 TRIMETHYLOLPROPANE COCONUT ETHER PHENOXYETHANOL SQUALANE OCTYLDODECYL NEOPENTANOATE SORBITAN ISOSTEARATE .BETA.-SITOSTEROL CERAMIDE NG CERAMIDE NP
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.Barrier Renew AM Moisturizer SPF 30 Label
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 Keep out of reach of children.
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? Questions or Comments? Call toll free 1-800-RoC-1964 (1-800-762-1964).
Storage and handling
Information about safe storage and handling of the drug product.Other Information Other information. Protect this product from excessive heat and direct sun. May stain some fabrics.
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 Warnings For external use only Do nut 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 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