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Recharge regimen for balancing, boosting and defending healthy-looking skin - Medication Information

Product NDC Code 14222-8000
Drug Name

Recharge regimen for balancing, boosting and defending healthy-looking skin

Type Brand
Active Ingredients
Titanium dioxide .032 g/ml
Zinc oxide .077 g/ml
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Rodan & Fields
Packages
Package NDC Code Description
14222-8000-1 1 tube in 1 carton (14222-8000-1) / 40 ml in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Titanium Dioxide 3.2% Zinc Oxide 7.7%

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 After moisturizing, apply generously at least 15 minutes before sun exposure using fingertips. Smooth and blend evenly over entire face in an outward direction. Wear alone or under makeup to prime skin. Reapply at least every 2 hours. Use a water-resistant sunscreen if swimming or sweating. Children under 6 months of age: ask a doctor. 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-sleeve shirts, pants, hats and sunglasses.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Isododecane, Cyclopentasiloxane, Dimethicone Crosspolymer, Calcium Sodium Borosilicate, Butyloctyl Salicylate, Jojoba Esters, Dimethicone, Glycerin, Sea Water/Maris Aqua/Eau De Mer, Hexyl Laurate, Acrylates/Dimethicone Copolymer, Water, Vaccinium Angustifolium (Blueberry) Fruit Extract, Carnosine, Sclareolide, Zinc PCA, Fragrance/Parfum, Silica, Dimethicone/Polyglycerin-3 Crosspolymer, Polyglyceryl-4 Isostearate, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Stearic Acid, Biosaccharide Gum-4, Methyl Carboxymethylphenyl Aminocarboxypropylphosphonate, Isopropyl Titanium Triisostearate, Tocopherol, Sodium Citrate, Butylene Glycol, Propanediol, Dipropylene Glycol, Phenoxyethanol, Hexyl Cinnamal, Limonene, Linalool, Alumina, Iron Oxides (Cl 77499).

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. 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.
Purpose Sunscreen Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skin TITANIUM DIOXIDE, ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE ISODODECANE CYCLOMETHICONE 5 BOROSILICATE GLASS BUTYLOCTYL SALICYLATE HYDROGENATED JOJOBA OIL/JOJOBA OIL, RANDOMIZED (IODINE VALUE 64-70) DIMETHICONE GLYCERIN WATER HEXYL LAURATE PROPANEDIOL POLYGLYCERYL-4 ISOSTEARATE BUTYLENE GLYCOL STEARIC ACID ALUMINUM OXIDE ZINC PIDOLATE SCLAREOLIDE CARNOSINE SILICON DIOXIDE LOWBUSH BLUEBERRY PHENOXYETHANOL LINALOOL, (+/-)- BIOSACCHARIDE GUM-4 FERRIC OXIDE RED DIPROPYLENE GLYCOL .ALPHA.-HEXYLCINNAMALDEHYDE LIMONENE, (+)- SODIUM CITRATE, UNSPECIFIED FORM CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) TOCOPHEROL ISOPROPYL TITANIUM TRIISOSTEARATE

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 - Carton Label RODAN + FIELDS RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking Skin Based on Multi-Med Therapy, RECHARGE is a multitasking skincare system that acts like a nutrient-rich super vitamin to balance and boost skin's defenses — visibly improving skin with the first use. Each step is clinically tested so they work together to defend against premature aging and repair skin's moisture barrier. This 3-step Regimen was developed by Stanford-trained Dermatologists Dr. Katie Rodan and Dr. Kathy Fields. RDDAN + FIELDS 3-in-1 Super Cleanser 125 mL / 4.2 Fl. Oz. U.S. Ultra Boost Moisturizing Treatment 50 mL / 1.7 FI. Oz. U.S. Protect + Blur Broad Spectrum SPF 30 Sunscreen 40 mL / 1.35 FI. Oz. U.S. Principal Display Panel - Carton Label

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.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information Protect the product in this container from excessive heat and direct sun.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions 1-888-995-5656

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.

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