Fotoskinox Face Cream Sunscreen

Avobenzone, Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide

Hans Biomed S.l.
Human Otc Drug
NDC 82601-200

Fotoskinox Face Cream Sunscreen also known as Avobenzone, Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide is a human otc drug labeled by 'Hans Biomed S.l.'. National Drug Code (NDC) number for Fotoskinox Face Cream Sunscreen is 82601-200. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Fotoskinox Face Cream Sunscreen drug includes Avobenzone - 3 mg/100mL Ensulizole - 3 mg/100mL Octinoxate - 4 mg/100mL Octocrylene - 2 mg/100mL Titanium Dioxide - 2.6 mg/100mL . The currest status of Fotoskinox Face Cream Sunscreen drug is Active.

Drug Information:

Drug NDC:	82601-200
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:	Fotoskinox Face Cream 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:	Avobenzone, Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Hans Biomed S.l.
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:	AVOBENZONE - 3 mg/100mL ENSULIZOLE - 3 mg/100mL OCTINOXATE - 4 mg/100mL OCTOCRYLENE - 2 mg/100mL TITANIUM DIOXIDE - 2.6 mg/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:	30 Jun, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	14 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:	HANS BIOMED S.L.
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:	G63QQF2NOX 9YQ9DI1W42 4Y5P7MUD51 5A68WGF6WM 15FIX9V2JP
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
82601-200-01	1 TUBE in 1 CARTON (82601-200-01) / 50 mL in 1 TUBE	30 Jun, 2022	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.

Other medicines with the same generic name

Fotoskinox Face Cream Sunscreen

Avobenzone, Ensulizole, Octinoxate, Octocrylene, Titanium Dioxide

Cream
HANS BIOMED S.L.
NDC: 82601-200

Purpose:

Uses helps prevent sunburn if used as directed with other protection measures (see directions ), decreases the risk of skin cancer and early skin aging caused by the sun.

Product Elements:

Fotoskinox face cream sunscreen avobenzone, ensulizole, octinoxate, octocrylene, titanium dioxide water dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) glyceryl stearate se ethylhexylglycerin avobenzone avobenzone ensulizole ensulizole propanediol ceteth-20 hydrated silica polygonum aviculare whole lecithin, soybean linalool, (+)- dicaprylyl ether ethyl macadamiate butylene glycol sodium polyacrylate (8000 mw) cetyl alcohol gossypium herbaceum flower octinoxate octinoxate octocrylene octocrylene titanium dioxide titanium dioxide phenoxyethanol glycerin peg-75 stearate citric acid monohydrate squalane steareth-20 alteromonas macleodii polysaccharides potassium sorbate sodium benzoate tocopherol malic acid acetyl hexapeptide-49 hydroxycitronellal geraniol

Indications and Usage:

Warnings for external use only

Directions for sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water-resistant sunscreen if swimming or sweating sun protection measures. spending time in the sun increases your risk of skin cancer and early skin aging. to decrease this risk, regualrly use a sunscreen with a broad spectrum spf value o 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. to 2 p.m. wear long-sleeved shirts, pants, hats and, sunglasses. children under 6 months of age: ask a doctor.

Do Not Use:

When Using:

Warnings when using this product keep out of eyes. rinse with water to remove.

Package Label Principal Display Panel:

Outer packaging 50 ml ndc 82601-200-01 50 ml ndc 82601-200-01

Further Questions:

Questions or comments? usa@skymedic.eu

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.