Blue Lizard Sport Sunscreen
Octocrylene And Zinc Oxide
Crown Laboratories
Human Otc Drug
NDC 0316-2021Blue Lizard Sport Sunscreen also known as Octocrylene And Zinc Oxide is a human otc drug labeled by 'Crown Laboratories'. National Drug Code (NDC) number for Blue Lizard Sport Sunscreen is 0316-2021. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Blue Lizard Sport Sunscreen drug includes Octocrylene - 41.8 mg/mL Zinc Oxide - 104.5 mg/mL . The currest status of Blue Lizard Sport Sunscreen drug is Active.
Drug Information:
| Drug NDC: | 0316-2021 |
| 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: | Blue Lizard Sport 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: | Octocrylene And Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Crown Laboratories |
| 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: | OCTOCRYLENE - 41.8 mg/mL
ZINC OXIDE - 104.5 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 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: | 02 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 10 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: | Crown Laboratories
|
| 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: | 0303162021303
|
| UPC stands for Universal Product Code. |
| UNII: | 5A68WGF6WM
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 |
|---|
| 0316-2021-10 | 5 mL in 1 PACKET (0316-2021-10) | 02 Jan, 2019 | N/A | Yes |
| 0316-2021-30 | 89 mL in 1 TUBE (0316-2021-30) | 02 Jan, 2019 | N/A | No |
| 0316-2021-40 | 1 BOTTLE, PLASTIC in 1 CARTON (0316-2021-40) / 148 mL in 1 BOTTLE, PLASTIC | 02 Jan, 2019 | N/A | No |
| 0316-2021-50 | 259 mL in 1 BOTTLE, PLASTIC (0316-2021-50) | 02 Jan, 2019 | 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:
Blue lizard sport sunscreen octocrylene and zinc oxide octocrylene octocrylene chlorphenesin ethylhexyl palmitate hydrogenated castor oil yellow wax cetyl peg/ppg-10/1 dimethicone (hlb 5) ethylhexyl stearate dimethicone zinc oxide zinc oxide caprylyl glycol hexadecyl povidone (4 hexadecyl branches/repeat) water .alpha.-tocopherol acetate sorbitan monooleate stearic acid trimethylsiloxysilicate (m/q 0.8-1.0) hexyl laurate methyl glucose dioleate peg-7 hydrogenated castor oil edetate disodium edetic acid octyldodecyl neopentanoate phenoxyethanol polyglyceryl-4 isostearate propanediol triethoxycaprylylsilane cetyl dimethicone 25
Indications and Usage:
Uses helps prevent sunburn and photodamage caused by uva/uvb exposure higher spf gives more sunburn protection if used as directed with other sun protection measures (see directions ), decreases the risk of skin cancer and early skin aging caused by the sun
Warnings:
Warnings when using this product keep out of eyes. rinse with water to remove stop use and ask a doctor if rash or irritation occurs do not use on damaged or broken skin if allergic to any ingredient if swallowed, get medical help or contact a poison control center
Package Label Principal Display Panel:
Blue lizard sport 3oz label blue lizard australian sunscreen 30+ uva/uvb protection broad spectrum spf 30+ trusted by dermatologists for over 20 years sport mineral-based sunscreen combining mineral and chemical uv protectors for water-resistance performance you can trust. smart cap technology cap changes color in harmful uv light water resistant (80 minutes) p11449.02 p1144902
Further Questions:
Questions? visit www.bluelizardsunscreen.com or call 800.877.8869 crown laboratories, inc., johnson city, tn 37604