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Product NDC Code | 54111-122 | ||||
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Drug Name | Rodan and fields unblemish |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | Bentley Laboratories, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS: Titanium Dioxide 0.7% Zinc Oxide 4.75%
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 a generous dime-sized amount evenly over the entire face every morning, 15 minutes before sun exposure, as the final step in the Regimen. Reapply every 2 hours when exposed to the sun. Avoid the eye area.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS: Water, Cyclopentasiloxane, Isododecane, Pentylene Glycol, Cetearyl Alcohol, Polysilicone-11, PEG-10 Dimethicone, Butylene Glycol, Polysorbate 60, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Glyceryl Stearate, Caprylyl Glycol, Squalane, Citric Acid, Xanthan Gum, 1,2-Hexanediol, PEG-60 Almond Glycerides, Ceteth-10 Phosphate, Oleanolic Acid, Nordihydroguaiaretic Acid, Glycerin, Carbomer, Chlorphenesin, Dimethiconol, Dicetyl Phosphate, Cholesterol, Hexyl Laurate, Fragrance, Polyglyceryl-4 Isostearate, Potassium Sorbate, Sodium Benzoate, Tocopherol, Disodium EDTA, Tetrahexyldecyl Ascorbate, Azelaic Acid, Stearic Acid, Lecithin, Alumina, Sodium Chondroitin Sulfate, Atelocollagen, Boerhavia Diffusa Root Extract, Methylisothiazolinone, Tropolone
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: Sunscreens
Spl product data elements
Usually a list of ingredients in a drug product.RODAN and FIELDS UNBLEMISH TITANIUM DIOXIDE, ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER CYCLOMETHICONE 5 ISODODECANE PENTYLENE GLYCOL CETOSTEARYL ALCOHOL PEG-10 DIMETHICONE (600 CST) BUTYLENE GLYCOL POLYSORBATE 60 DIMETHICONE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) PEG-100 STEARATE GLYCERYL MONOSTEARATE CAPRYLYL GLYCOL SQUALANE CITRIC ACID MONOHYDRATE XANTHAN GUM 1,2-HEXANEDIOL PEG-60 ALMOND GLYCERIDES CETETH-10 PHOSPHATE OLEANOLIC ACID MASOPROCOL GLYCERIN CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) CHLORPHENESIN DIHEXADECYL PHOSPHATE CHOLESTEROL HEXYL LAURATE POLYGLYCERYL-4 ISOSTEARATE POTASSIUM SORBATE SODIUM BENZOATE TOCOPHEROL EDETATE SODIUM TETRAHEXYLDECYL ASCORBATE AZELAIC ACID STEARIC ACID EGG PHOSPHOLIPIDS ALUMINUM OXIDE SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) BOERHAVIA DIFFUSA ROOT METHYLISOTHIAZOLINONE TROPOLONE
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.RODAN and FIELDS UNBLEMISHED Label RODAN and FIELDS UNBLEMISHED 4 Oil Control Lotion BROAD SPECTRUM SPF 20 SUNSCREEN Manufactured for Rodan and Fields, LLC San Francisco, CA 94105 Made in USA UNSS030 85-07-0015 Please recycle visit rodanandfields.com QUESTIONS OR COMMENTS 1-888-995-5656 30mL/1 Fl. Oz. RF_Unblemished RF_Unblemished1
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. If swallowed, get medical help or contact a Poison Control Center right away.
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. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with warm water to remove.
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