The Tinted Serum Broad Spectrum Spf 50+
Zinc Oxide
Rationale Group Pty Ltd
Human Otc Drug
NDC 83108-001The Tinted Serum Broad Spectrum Spf 50+ also known as Zinc Oxide is a human otc drug labeled by 'Rationale Group Pty Ltd'. National Drug Code (NDC) number for The Tinted Serum Broad Spectrum Spf 50+ is 83108-001. This drug is available in dosage form of Emulsion. The names of the active, medicinal ingredients in The Tinted Serum Broad Spectrum Spf 50+ drug includes Zinc Oxide - 240 mg/mL . The currest status of The Tinted Serum Broad Spectrum Spf 50+ drug is Active.
Drug Information:
| Drug NDC: | 83108-001 |
| 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: | The Tinted Serum Broad Spectrum 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: | Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Rationale Group Pty Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Emulsion |
| 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 - 240 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: | 25 Nov, 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: | Rationale Group Pty Ltd
|
| 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: | 9359782001608
|
| 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 |
|---|
| 83108-001-00 | 1 BOTTLE, DROPPER in 1 BOX (83108-001-00) / 30 mL in 1 BOTTLE, DROPPER | 25 Nov, 2022 | N/A | No |
| 83108-001-03 | 3 mL in 1 BOTTLE, DROPPER (83108-001-03) | 08 Dec, 2022 | N/A | Yes |
| 83108-001-05 | 5 mL in 1 BOTTLE, DROPPER (83108-001-05) | 08 Dec, 2022 | N/A | Yes |
| 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:
The tinted serum broad spectrum spf 50+ zinc oxide trisiloxane isoamyl laurate alkyl (c12-15) benzoate butyloctyl salicylate cyclomethicone 5 ethylhexyl methoxycrylene water tricontanyl povidone argan oil .alpha.-tocopherol acetate pentaerythrityl tetraisostearate propanediol isostearic acid glyceryl caprylate titanium dioxide boron nitride 1,2-hexanediol mica disteardimonium hectorite glycerin sodium chloride ferric oxide yellow levomenol propylene carbonate green tea leaf caprylhydroxamic acid limonene, (+)- citrus bergamia leaf oil orange oil, cold pressed juniperus deppeana wood oil geranium oil, algerian type 7-dehydrocholesterol citrus aurantium flower oil clove leaf oil maltodextrin silicon dioxide ferric oxide red anigozanthos flavidus flowering top syzygium luehmannii fruit stannic oxide aspalathus linearis leaf butylene glycol sodium lactate sodium pyrrolidone carboxylate ferrosoferric oxide pentylene glycol ceteareth-25 linalool, (+/-)- dimethicone magnesium aspartate zinc gluconate cetyl alcohol .beta.-citronellol, (r)- hyaluronate sodium davidsonia pruriens fruit sodium benzoate glycine ethylhexylglycerin potassium sorbate behenic acid ceramide np cholesterol copper gluconate fructose inositol lactic acid niacinamide urea phenoxyethanol citric acid monohydrate ceramide ng serine glutamic acid ceramide ap 3-dehydroxy ceramide 1 aspartic acid leucine caprooyl phytosphingosine n-hexanoylsphingosine alanine lysine arginine tyrosine phenylalanine dipivefrin hydrochloride threonine valine isoleucine histidine zinc oxide zinc cation
Indications and Usage:
Uses helps prevent sunburn. if used as directed with other sun protection measures ( see directions ), decreases the risk of skin cancer and early skin ageing caused by the sun.
Warnings:
Warnings for external use only. do not use on damaged or broken skin. when using this product keep out of eyes. rinse with water to remove. stop use and ask a doctor if rash occurs. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Do Not Use:
Warnings for external use only. do not use on damaged or broken skin. when using this product keep out of eyes. rinse with water to remove. stop use and ask a doctor if rash occurs. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product keep out of eyes. rinse with water to remove.
Dosage and Administration:
Directions 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 ageing. to decrease this risk, regularly use a sunscreen with a broad spectrum spf value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m -2p.m. wear long sleeved shirts, pants, hats and sunglasses. children under 6 months of age: ask a doctor.
Stop Use:
Stop use and ask a doctor if rash occurs.
Package Label Principal Display Panel:
Package labeling: label2
Package labeling:3ml sfc1 3ml5mlc ml3
Package labeling:5ml sfc2 3ml5mlcombo ml5