Broad Spectrum Spf 30 For Face And Body
Zinc Oxide
Allure Labs Inc
Human Otc Drug
NDC 62742-4116Broad Spectrum Spf 30 For Face And Body also known as Zinc Oxide is a human otc drug labeled by 'Allure Labs Inc'. National Drug Code (NDC) number for Broad Spectrum Spf 30 For Face And Body is 62742-4116. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Broad Spectrum Spf 30 For Face And Body drug includes Zinc Oxide - 186 mg/g . The currest status of Broad Spectrum Spf 30 For Face And Body drug is Active.
Drug Information:
| Drug NDC: | 62742-4116 |
| 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: | Broad Spectrum Spf 30 For Face And Body |
| 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: | Allure Labs Inc |
| 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 - 186 mg/g
|
| 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: | 04 Dec, 2017 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 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: | Allure Labs 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: | 0651936740005
|
| 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. |
| Pharmacologic Class: | Copper Absorption Inhibitor [EPC]
Decreased Copper Ion Absorption [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 62742-4116-1 | 68 g in 1 TUBE (62742-4116-1) | 04 Dec, 2017 | 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:
Broad spectrum spf 30 for face and body zinc oxide zinc oxide zinc cation water dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) cyclomethicone glycerin glyceryl monostearate peg-100 stearate polyglyceryl-3 polydimethylsiloxyethyl dimethicone (4000 mpa.s) sorbitan monostearate dimethicone cetyl alcohol lecithin, soybean imperata cylindrica root polyacrylamide (10000 mw) c13-14 isoparaffin carica papaya leaf aloe vera leaf peg-8 caprylic/capric glycerides carbomer copolymer type a (allyl pentaerythritol crosslinked) phenoxyethanol caprylyl glycol ethylhexylglycerin hexylene glycol laureth-7 xanthan gum edetate disodium
Indications and Usage:
Uses: provided high protection against sunburn. broad spectrum (uva and uvb) protection. if used with directed with other sun protection measures,decreases the risk of skin cancer and early skin aging caused by sun.
Warnings:
Warnings: for external use only.
When Using:
When using this product keep out of eyes.rinse with water to remove.
Dosage and Administration:
Directions: apply generously 15 minutes before su exposure. reapply at least every 2 hours. after swimming or sweating. immediately after towel drying. children under 6 months of age: ask a doctor.
Stop Use:
Stop use and ask a doctor if rash or irritation occurs.
Package Label Principal Display Panel:
Made in usa sun research llc santa cruz, ca www.burnoutsun.com spf 30 face body 24
Further Questions:
Call toll free 1-800-798-7970