Al0040400 Alba Ve Mineral Sunscreen Spf35
Zinc Oxide, Titanium Dioxide
The Hain Celestial Group, Inc.
Human Otc Drug
NDC 61995-2404Al0040400 Alba Ve Mineral Sunscreen Spf35 also known as Zinc Oxide, Titanium Dioxide is a human otc drug labeled by 'The Hain Celestial Group, Inc.'. National Drug Code (NDC) number for Al0040400 Alba Ve Mineral Sunscreen Spf35 is 61995-2404. This drug is available in dosage form of Spray. The names of the active, medicinal ingredients in Al0040400 Alba Ve Mineral Sunscreen Spf35 drug includes Titanium Dioxide - 6.8 g/100g Zinc Oxide - 6.4 g/100g . The currest status of Al0040400 Alba Ve Mineral Sunscreen Spf35 drug is Active.
Drug Information:
| Drug NDC: | 61995-2404 |
| 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: | Al0040400 Alba Ve Mineral Sunscreen Spf35 |
| 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, Titanium Dioxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | The Hain Celestial Group, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Spray |
| 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: | TITANIUM DIOXIDE - 6.8 g/100g
ZINC OXIDE - 6.4 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 NOT 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: | 13 Jan, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 Jun, 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, 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: | The Hain Celestial Group, Inc.
|
| 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: | 0724742004040
|
| UPC stands for Universal Product Code. |
| UNII: | 15FIX9V2JP
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 |
|---|
| 61995-2404-6 | 177 g in 1 CAN (61995-2404-6) | 13 Jan, 2016 | 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:
Sunscreen
Product Elements:
Al0040400 alba ve mineral sunscreen spf35 zinc oxide, titanium dioxide calendula officinalis flower hydrogenated jojoba oil, randomized coco-caprylate matricaria recutita glyceryl oleate xanthan gum polyhydroxystearic acid (2300 mw) medium-chain triglycerides .alpha.-tocopherol acetate zinc oxide zinc oxide phenoxyethanol potassium sorbate aloe vera leaf titanium dioxide titanium dioxide glycerin water green tea leaf ginkgo sodium chloride stearic acid
Indications and Usage:
Helps prevent sunburn. if used as directed with other sun protection measures (see directions ), decreases risk of skin cancer and early skin aging caused by the sun.
Warnings:
For external use only. do not puncture or incinerate. contents under preassure. do not store at temperature above 120°. do not use on damaged or broken skin. when using this product keep out of eyes. rinse with water to remove. stop using and ask a doctor if skin rash occurs.
When Using:
Shake well before use. apply liberally 15 minutes before sun explosure. hold 4-6 inches away from body when spraying. do not spray directly on face and avoid breathing mist. spray on hand and apply to face. use in well ventillated areas. reapply after 80 minutes of swimming or sweating, immideately after towel drying and at least every 2 hours. cildren under 6 months: ask doctor. sun protection measures: spending time in the sun increasis your risk of skin cancer and early skin aging. to decrease risk, regulary use a sunscreen with broad spectrum spf 15 or higher and other preventive measures including: limit time in sun, especially from 10 am to 2 pm, and wear long-sleeved shirts, pants, hats and sunglasses.
Package Label Principal Display Panel:
Can label