Every Day Mineral Sun Screen Spf 45
Zinc Oxide
Stream2sea, Llc
Human Otc Drug
NDC 69555-045Every Day Mineral Sun Screen Spf 45 also known as Zinc Oxide is a human otc drug labeled by 'Stream2sea, Llc'. National Drug Code (NDC) number for Every Day Mineral Sun Screen Spf 45 is 69555-045. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Every Day Mineral Sun Screen Spf 45 drug includes Zinc Oxide - 190 mg/mL . The currest status of Every Day Mineral Sun Screen Spf 45 drug is Active.
Drug Information:
| Drug NDC: | 69555-045 |
| 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: | Every Day Mineral Sun Screen Spf 45 |
| 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: | Stream2sea, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - 190 mg/mL
|
| 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: | 11 Nov, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | part352 |
| 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, 2024 |
| 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: | Stream2Sea, LLC
|
| 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: | 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 |
|---|
| 69555-045-01 | 75 mL in 1 TUBE (69555-045-01) | 11 Nov, 2021 | N/A | No |
| 69555-045-02 | 50 mL in 1 TUBE (69555-045-02) | 11 Nov, 2021 | N/A | No |
| 69555-045-03 | 946 mL in 1 TUBE (69555-045-03) | 11 Nov, 2021 | N/A | No |
| 69555-045-04 | 75 mL in 1 TUBE (69555-045-04) | 11 Nov, 2021 | N/A | No |
| 69555-045-05 | 50 mL in 1 TUBE (69555-045-05) | 11 Nov, 2021 | N/A | No |
| 69555-045-06 | 946 mL in 1 TUBE (69555-045-06) | 11 Nov, 2021 | N/A | No |
| 69555-045-07 | 75 mL in 1 TUBE (69555-045-07) | 11 Nov, 2021 | N/A | No |
| 69555-045-08 | 50 mL in 1 TUBE (69555-045-08) | 11 Nov, 2021 | N/A | No |
| 69555-045-09 | 946 mL in 1 TUBE (69555-045-09) | 11 Nov, 2021 | N/A | No |
| 69555-045-10 | 75 mL in 1 TUBE (69555-045-10) | 11 Nov, 2021 | N/A | No |
| 69555-045-11 | 50 mL in 1 TUBE (69555-045-11) | 11 Nov, 2021 | N/A | No |
| 69555-045-12 | 946 mL in 1 TUBE (69555-045-12) | 11 Nov, 2021 | 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:
Every day mineral sun screen spf 45 zinc oxide water aloe vera leaf coco-caprylate isoamyl laurate glycerin polyglyceryl-3 oleate propanediol polyhydroxystearic acid (2300 mw) diisostearoyl polyglyceryl-3 dimer dilinoleate mica tricaprin sodium chloride ethyl lauroyl arginate hydrochloride hydrolyzed jojoba esters (acid form) olive oil alaria esculenta olea europaea leaf green tea leaf holy basil leaf coconut oil turmeric tetrasodium glutamate diacetate tocopherol sodium stearoyl glutamate silicon dioxide xanthan gum ferric oxide red zinc oxide zinc oxide
Indications and Usage:
Uses helps prevent sunburn
Warnings:
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 water to remove.
Package Label Principal Display Panel:
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