Soothe Regimen For Sensitive Skin
Allantoin, Dimethicone, Titanium Dioxide, Zinc Oxide
Rodan & Fields
Human Otc Drug
NDC 14222-1010Soothe Regimen For Sensitive Skin also known as Allantoin, Dimethicone, Titanium Dioxide, Zinc Oxide is a human otc drug labeled by 'Rodan & Fields'. National Drug Code (NDC) number for Soothe Regimen For Sensitive Skin is 14222-1010. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Soothe Regimen For Sensitive Skin drug includes . The currest status of Soothe Regimen For Sensitive Skin drug is Active.
Drug Information:
| Drug NDC: | 14222-1010 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Soothe Regimen For Sensitive Skin |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Allantoin, Dimethicone, Titanium Dioxide, Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rodan & Fields |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Jun, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 Jul, 2023 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 10 May, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Rodan & Fields
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 14222-1010-1 | 1 KIT in 1 CARTON (14222-1010-1) * 50 mL in 1 TUBE * 50 mL in 1 TUBE | 01 Jun, 2017 | 07 Jul, 2023 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose sunscreen
Purpose skin protectant
Product Elements:
Soothe regimen for sensitive skin allantoin, dimethicone, titanium dioxide, zinc oxide sensitive skin treatment allantoin, dimethicone allantoin allantoin dimethicone dimethicone water glycerin isododecane rice bran chamomile pelargonium graveolens flower oil lavender oil indian frankincense oligopeptide-10 tocopherol tropolone tranexamic acid honey soybean germ perilla frutescens seed oil sunflower oil levomenol angelica sinensis root linoleic acid linolenic acid butylene glycol coco-caprylate/caprate decyl glucoside hydrogenated polybutene (1300 mw) peg-40 stearate lecithin, soybean polyglyceryl-10 stearate dimethicone/vinyl dimethicone crosspolymer (soft particle) xanthan gum hexylene glycol stannic oxide 1,2-hexanediol caprylyl glycol chlorhexidine gluconate chlorphenesin phenoxyethanol potassium sorbate sodium benzoate .beta.-citronellol, (r)- geraniol linalool, (+/-)- mica titanium dioxide mineral sunscreen broad spectrum spf 30 titanium dioxide, zinc oxide titanium dioxide titanium dioxide zinc oxide zinc oxide cyclomethicone 5 water cyclomethicone 6 peg-10 dimethicone (600 cst) butylene glycol dimethicone aluminum starch octenylsuccinate caprylyl trisiloxane dimethicone/vinyl dimethicone crosspolymer (soft particle) dipropylene glycol glycerin green tea leaf hyaluronate sodium glycyrrhiza glabra glycyrrhizinate dipotassium panthenol .alpha.-tocopherol acetate sodium pyrrolidone carboxylate aluminum oxide disteardimonium hectorite isoceteth-10 methicone (20 cst) silicon dioxide sodium chloride edetate disodium anhydrous caprylyl glycol ethylhexylglycerin potassium sorbate phenoxyethanol methylparaben ethylparaben butylparaben
Indications and Usage:
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
Uses temporarily protects and helps relieve chapped or cracked skin helps protect from the drying effects of wind and cold weather
Warnings:
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 doctor if rash occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away
Warnings for external use only when using this product do not get into eyes stop use and ask doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days do not use on deep or puncture wounds animal bites serious burns keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. when using this product keep out of eyes. rinse with water to remove. if irritation or rash occurs, discontinue use and consult your doctor. keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. when using this product keep out of eyes. rinse with water to remove. if irritation or rash occurs, discontinue use and consult your doctor. keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.
Do Not Use:
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 doctor if rash occurs keep out of reach of children. if swallowed, get medical help or contact a poison control center right away
Warnings for external use only when using this product do not get into eyes stop use and ask doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days do not use on deep or puncture wounds animal bites serious burns keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. when using this product keep out of eyes. rinse with water to remove. if irritation or rash occurs, discontinue use and consult your doctor. keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.
Warnings for external use only. when using this product keep out of eyes. rinse with water to remove. if irritation or rash occurs, discontinue use and consult your doctor. keep out of reach of children. if product is swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product keep out of eyes. rinse with water to remove
When using this product do not get into eyes
Dosage and Administration:
Directions apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m.â2 p.m. wear long-sleeve shirts, pants, hats and sunglasses children under 6 months: ask a doctor
Directions apply a thin, even layer over the entire face, avoiding the eye area. do not rinse off. use twice daily. apply as needed.
Directions apply a generous dime-sized amount evenly over the entire face every morning and evening, avoiding the eye area. use after soothe gentle cream wash and soothe sensitive skin treatment, and follow with soothe mineral sunscreen in the morning.
Directions use in the morning and evening. prior to using, remove any facial makeup. apply a thin, even layer over entire face, avoiding the eye area. for oily skin, rinse thoroughly and pat dry. for dry skin, remove with a fresh, dry gauze pad.
Stop Use:
Stop use and ask doctor if rash occurs
Stop use and ask doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days
Package Label Principal Display Panel:
Principal display panel - rodan fields soothe sensitive skin treatment label rodan + fields ® soothe 2 sensitive skin treatment principal display panel - rodan fields soothe sensitive skin treatment label
Principal display panel - rodan fields soothe mineral sunscreen label rodan + fields ® soothe 4 mineral sunscreen broad spectrum spf 30 principal display panel - rodan fields soothe mineral sunscreen label
Principal display panel - rodan fields soothe carton label rodan + fields ® soothe⢠regimen for sensitive skin based on multi-med ® therapy, soothe is a complete skincare system that uses clinically tested cosmetic and otc ingredients to defend against dry, chapped, sensitive skin, and to soothe and calm visible facial redness. this 4-product regimen was developed by stanford-trained dermatologists dr. katie rodan and dr. kathy fields. rodan + fields ® gentle cream wash 125 ml/ 4.2 fl.oz. u.s. sensitive skin treatment skin protectant 50 ml/ 1.7 fl.oz. u.s. moisture replenishing cream 50 ml/ 1.7 fl.oz. u.s. mineral sunscreen broad spectrum spf 30 water resistant (80 minutes) 50 ml/ 1.7 fl.oz. u.s. principal display panel - rodan fields soothe carton label