Sunscreen
Zinc Oxide
Ca-botana International
Human Otc Drug
NDC 35192-051Sunscreen also known as Zinc Oxide is a human otc drug labeled by 'Ca-botana International'. National Drug Code (NDC) number for Sunscreen is 35192-051. This drug is available in dosage form of Emulsion. The names of the active, medicinal ingredients in Sunscreen drug includes Zinc Oxide - 21 g/100g . The currest status of Sunscreen drug is Active.
Drug Information:
| Drug NDC: | 35192-051 |
| 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: | Sunscreen |
| 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: | Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Ca-botana International |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Emulsion |
| 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: | ZINC OXIDE - 21 g/100g
|
| 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: | OTC MONOGRAPH FINAL |
| 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: | 12 Sep, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 2026 |
| 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. |
| Application Number: | M020 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| 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: | CA-Botana International
|
| 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. |
| UPC: | 0196852191994
|
| UPC stands for Universal Product Code. |
| UNII: | SOI2LOH54Z
|
| 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 |
|---|
| 35192-051-01 | 62.3 g in 1 PACKAGE (35192-051-01) | 30 Sep, 2022 | N/A | 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
Product Elements:
Sunscreen zinc oxide ascorbyl palmitate mica horse chestnut green tea leaf peg-8 caprylic/capric glycerides triethoxycaprylylsilane safflower oil glyceryl stearate se sorbitan olivate equisetum arvense whole ascorbic acid stearyl alcohol polyhydroxystearic acid (2300 mw) cetearyl olivate rosemary zinc oxide zinc oxide potassium sorbate tocopherol xanthan gum glycerin propanediol water brown iron oxide hexasodium phytate anhydrous citric acid coco-caprylate/caprate caprylhydroxamic acid glyceryl caprate centella asiatica green olive .alpha.-tocopherol acetate, dl- hydrated silica light brownish
Indications and Usage:
Indications & usage apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. children under 6 months: ask a doctor
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. if product is swallowed get medical help or contact a poison control center right away.
Dosage and Administration:
Dosage & administration helps prevent sunburn. if used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. apply liberally 15 minutes before sun exposure. usea water resistant sunscreen if swimming or sweating. reapply : at least 2 hours. children under 6 months: ask a doctor. sun protections measurements. 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 othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m wear long-sleeveshirts, pants, hats, and sunglasses. protect this product from excessive heat and direct sun.
Package Label Principal Display Panel:
Package label principal display panel bright rhythm.jpg