Zo Skin Health Broad-spectrum Sunscreen Spf 50
Titanium Dioxide, Zinc Oxide
Zo Skin Health, Inc.
Human Otc Drug
NDC 42851-064Zo Skin Health Broad-spectrum Sunscreen Spf 50 also known as Titanium Dioxide, Zinc Oxide is a human otc drug labeled by 'Zo Skin Health, Inc.'. National Drug Code (NDC) number for Zo Skin Health Broad-spectrum Sunscreen Spf 50 is 42851-064. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Zo Skin Health Broad-spectrum Sunscreen Spf 50 drug includes Titanium Dioxide - 7.552 mg/118g Zinc Oxide - 17.7 mg/118g . The currest status of Zo Skin Health Broad-spectrum Sunscreen Spf 50 drug is Active.
Drug Information:
| Drug NDC: | 42851-064 |
| 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: | Zo Skin Health Broad-spectrum Sunscreen Spf 50 |
| 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: | Titanium Dioxide, Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Zo Skin Health, 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: | TITANIUM DIOXIDE - 7.552 mg/118g
ZINC OXIDE - 17.7 mg/118g
|
| 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: | 15 Aug, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 20 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: | ZO Skin Health, 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 |
|---|
| 42851-064-04 | 1 TUBE in 1 CARTON (42851-064-04) / 118 g in 1 TUBE | 15 Aug, 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. |
Purpose:
Uses helps prevent sunburn
Product Elements:
Zo skin health broad-spectrum sunscreen spf 50 titanium dioxide, zinc oxide phenoxyethanol silicon dioxide 1,2-hexanediol aluminum oxide water dimethicone crosspolymer (450000 mpa.s at 12% in cyclopentasiloxane) erythritol ethylhexylglycerin hexyl laurate glycyrrhiza uralensis root butylene glycol glycerin ascorbic acid calcium chloride dimethicone homarine hydrochloride polyglyceryl-4 isostearate vitamin a palmitate solanum anomalum whole sodium c14-16 olefin sulfonate sodium chloride sodium citrate titanium dioxide titanium dioxide sodium benzoate poly(methyl methacrylate; 450000 mw) potassium sorbate ferric oxide red scutellaria lateriflora top stearic acid squalane .alpha.-tocopherol acetate levomenol pentylene glycol cetyl peg/ppg-10/1 dimethicone (hlb 2) tribehenin zinc oxide zinc oxide
Warnings and Cautions:
Warnings for external use only.
Do Not Use:
When Using:
When using this product keep out of eyes. rinse with water to remove.
Stop Use:
Stop use and ask a doctor if rash occurs.
Package Label Principal Display Panel:
Outer package label zo® skin health by zein obagi md ndc 42851-064-04 broad-spectrum sunscreen spf 50 for sensitized skin zox 12® lightweight, non-irritating mineral sunscreen for the most sensitive skin types and post-procedure skin. provides broad-spectrum protection against uva/uvb rays. natural melanin shields skin from aging effects of high-energy visible (hev) light. oxybenzone free. zox 12® engineered with our exclusive 12-hour, time-release zox12® complex, our sunscreens help shield the skin from harmful infrared (ir-a) rays. dist. by zo skin health, inc. irvine, ca 92618 made in usa with us & imported materials zoskinhealth.com broad-spectrum sunscreen spf 50