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Product NDC Code | 73496-004 | ||||||
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Drug Name | Roc retinol correxion wrinkle correct daily 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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Active ingredient
A list of the active, medicinal ingredients in the drug product.Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0 %.......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 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.Water, Glycerin, Diethylhexyl 2,6-Naphthalate, Dimethicone, Tetrahydroxypropyl Ethylenediamine, Butylene Glycol, Cyclohexasiloxane, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, PPG-2 Myristyl Ether Propionate, Pentaerythrityl Tetraethylhexanoate, Squalane, Propanediol, Styrene/Acrylates Copolymer, Glyceryl Stearate, Aluminum Starch Octenylsuccinate, Retinol, Glycolic Acid, Tocopheryl Acetate, Ascorbyl Palmitate, Allantoin, p-Anisic Acid, Pentylene Glycol, Ceteth-20, Steareth-20, Polyacrylamide, PEG-8 Laurate, Laureth-7, C13-14 Isoparaffin, Ammonium Acryloyldimethyltaurate/VP Copolymer, PEG-75 Stearate, Cyclopentasiloxane, Polysorbate 20, Ascorbic Acid, Hydroxyphenyl Propamidobenzoic Acid, Caprylhydroxamic Acid, 1,2-Hexanediol, BHT, Disodium EDTA, Sodium Hydroxide, Fragrance.
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.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
Purpose
Information about the drug product’s indications for 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
Spl product data elements
Usually a list of ingredients in a drug product.ROC RETINOL CORREXION WRINKLE CORRECT DAILY MOISTURIZER SPF 30 Avobenzone, Homosalate, Octisalate CYCLOMETHICONE 5 BUTYLATED HYDROXYTOLUENE SODIUM HYDROXIDE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE EDETOL ALPHA-TOCOPHEROL ACETATE CETETH-20 LAURETH-7 WATER DIETHYLHEXYL 2,6-NAPHTHALATE SHEA BUTTER SQUALANE GLYCERYL STEARATE SE ALUMINUM STARCH OCTENYLSUCCINATE GLYCOLIC ACID ASCORBYL PALMITATE CAPRYLHYDROXAMIC ACID CETYL ALCOHOL ALLANTOIN PEG-8 LAURATE PEG-75 STEARATE PPG-2 MYRISTYL ETHER PROPIONATE PENTAERYTHRITYL TETRAETHYLHEXANOATE PROPANEDIOL RETINOL P-ANISIC ACID PENTYLENE GLYCOL C13-14 ISOPARAFFIN AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER CYCLOMETHICONE 6 AVOBENZONE AVOBENZONE BUTYLENE GLYCOL STEARETH-20 POLYSORBATE 20 ASCORBIC ACID EDETATE DISODIUM HYDROXYPHENYL PROPAMIDOBENZOIC ACID 1,2-HEXANEDIOL GLYCERIN DIMETHICONE
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.Label Artwork-Carton
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.
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 toll free 1-800-RoC-1964 (1-800-762-1964) or 215-273-8755 (collect).
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product from excessive heat, freezing and direct sun May stain some fabrics Store between 20-25 °C (68-77 °F)
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 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