La Defense Broad Spectrum Spf 30 Mineral Sunscreen
Zinc Oxide, Titanium Dioxide
Luzern Laboratories, Inc
Human Otc Drug
NDC 63127-101La Defense Broad Spectrum Spf 30 Mineral Sunscreen also known as Zinc Oxide, Titanium Dioxide is a human otc drug labeled by 'Luzern Laboratories, Inc'. National Drug Code (NDC) number for La Defense Broad Spectrum Spf 30 Mineral Sunscreen is 63127-101. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in La Defense Broad Spectrum Spf 30 Mineral Sunscreen drug includes Titanium Dioxide - 3.57 g/100mL Zinc Oxide - 15 g/100mL . The currest status of La Defense Broad Spectrum Spf 30 Mineral Sunscreen drug is Active.
Drug Information:
| Drug NDC: | 63127-101 |
| 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: | La Defense Broad Spectrum Spf 30 Mineral 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, Titanium Dioxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Luzern Laboratories, Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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 - 3.57 g/100mL
ZINC OXIDE - 15 g/100mL
|
| 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: | 10 May, 2021 |
| 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: | Luzern Laboratories, 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. |
| 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 |
|---|
| 63127-101-01 | 1 TUBE in 1 CARTON (63127-101-01) / 60 mL in 1 TUBE | 10 May, 2021 | N/A | No |
| 63127-101-02 | 3 mL in 1 TUBE (63127-101-02) | 10 May, 2021 | N/A | No |
| 63127-101-03 | 240 mL in 1 BOTTLE (63127-101-03) | 10 May, 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:
La defense broad spectrum spf 30 mineral sunscreen zinc oxide, titanium dioxide zinc oxide zinc oxide titanium dioxide titanium dioxide argan oil levomenol buddleja davidii leaf c12-20 alkyl glucoside c14-22 alcohols green tea leaf caprylhydroxamic acid medium-chain triglycerides carboxypolymethylene cetyl alcohol chondrus crispus carrageenan citric acid monohydrate ethyl macadamiate ethylhexyl isononanoate ethylhexylglycerin glycerin glyceryl monocaprylate glyceryl isostearate glyceryl 1-undecylenate glycyrrhiza glabra sunflower oil hexyldecanol isostearyl palmitate arginine leontopodium nivale subsp. alpinum flowering top levulinic acid methylpropanediol octyldodecyl neopentanoate panthenol polyhydroxystearic acid stearate propanediol sodium ascorbyl phosphate hyaluronate sodium sodium levulinate sodium pyrrolidone carboxylate steareth-2 steareth-21 thyme tocopherol tocophersolan .alpha.-tocopherol acetate water ginger
Indications and Usage:
Uses: helps prevent sunburn
Warnings:
Warnings: for external use only avoid contact with eyes. if contact occurs, rinse thoroughly with water. do not use on damaged or broken skin. discontinue use if skin irritation develops or increases. if irritation persists, consult a health care practitioner. if swallowed, get medical help or contact a poison control center right away. keep out of reach of children. consult a health care practitioner prior to use on children less than six months of age.
Dosage and Administration:
Directions apply liberally/generously (and evenly) 15 minutes before sun exposure; reapply at least every 2 hours or after swimming, towel drying, perspiring heavily and washing; and for use on children less than 6 months of age, consult a health care practitioner. 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 value of 15 or higher and other measures including: ⢠limit time in the sun, especially from 10am â 2pm. ⢠wear long-sleeved shirts, pants, hats and sunglasses. ⢠reapply after 40 minutes of swimming or sweating. ⢠reapply immediately after towel drying.
Package Label Principal Display Panel:
Principal display panel â 60 ml carton label luzern la defÃnse broad spectrum spf 30 mineral sunscreen 2.0 fl oz / 60 mlâ® manufactured for and dist. by/fabriqué pour et distribué par luzern laboratories, inc 50 washington street, norwalk, ct 06854 / biorius / uk: shelton street 71- london wc2h9jq, great-britain / eu: rue wauters 113-7170 manage, belgium image-01
Principal display panel â 3 ml tube label luzern ® la defÃnse broad spectrum spf 30 mineral sunscreen 0.1 fl oz / 3 mlâ® manufactured for and dist. by/fabriqué pour et distribué par luzern laboratories, inc 50 washington street, norwalk, ct 06854 / biorius / uk: shelton street 71- london wc2h9jq, great-britain / eu: rue wauters 113-7170 manage, belgium image-02
Principal display panel â 240 ml bottle label professional luzern ® la defÃnse broad spectrum spf 30 mineral sunscreen 8.0 fl oz / 240 mlâ® manufactured for and dist. by/fabriqué pour et distribué par luzern laboratories, inc 50 washington street, norwalk, ct 06854 / biorius / uk: shelton street 71- london wc2h9jq, great-britain / eu: rue wauters 113-7170 manage, belgium image-03