S.o.s Cream Intensive Moisturizing Skin Protectant
Non Nano Zinc Oxide
Sbs Bilimsel Bio Cozumler Sanayi Ve Ticaret Anonim Sirketi Pinar Subesi
Human Otc Drug
NDC 82123-007S.o.s Cream Intensive Moisturizing Skin Protectant also known as Non Nano Zinc Oxide is a human otc drug labeled by 'Sbs Bilimsel Bio Cozumler Sanayi Ve Ticaret Anonim Sirketi Pinar Subesi'. National Drug Code (NDC) number for S.o.s Cream Intensive Moisturizing Skin Protectant is 82123-007. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in S.o.s Cream Intensive Moisturizing Skin Protectant drug includes Zinc Oxide - .6 mg/15mL . The currest status of S.o.s Cream Intensive Moisturizing Skin Protectant drug is Active.
Drug Information:
| Drug NDC: | 82123-007 |
| 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: | S.o.s Cream Intensive Moisturizing Skin Protectant |
| 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: | Non Nano Zinc Oxide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Sbs Bilimsel Bio Cozumler Sanayi Ve Ticaret Anonim Sirketi Pinar Subesi |
| 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: | ZINC OXIDE - .6 mg/15mL
|
| 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: | 11 Nov, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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: | part346 |
| 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: | SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI
|
| 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: | 0190853002433
|
| 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. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82123-007-16 | 1 CONTAINER in 1 BOX (82123-007-16) / 15 mL in 1 CONTAINER (82123-007-15) | 11 Nov, 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 antiseptic, hand sanitizer
Product Elements:
Sunscreen spf30 non nano zinc oxide xylityl sesquicaprylate water butyrospermum parkii (shea) butter unsaponifiables jojoba oil polyglyceryl-3 diisostearate white wax polyhydroxystearic acid (2300 mw) .alpha.-tocopherol acetate zinc oxide zinc oxide polyglyceryl-3 oleate propolis wax diisostearoyl polyglyceryl-3 dimer dilinoleate panthenol xanthan gum polyglyceryl-2 dipolyhydroxystearate medium-chain triglycerides coco-caprylate/caprate silicon dioxide magnesium sulfate anhydrous aloe vera leaf argan oil polyglyceryl-4 isostearate sunscreen for face spf30 non nano zinc oxide xylityl sesquicaprylate coco-caprylate/caprate olea europaea (olive) oil unsaponifiables zinc oxide zinc oxide caprylic/capric/lauric triglyceride aloe vera leaf polyglyceryl-3 diisostearate dicaprylyl carbonate panthenol butyrospermum parkii (shea) butter unsaponifiables magnesium sulfate anhydrous glyceryl citrate polyhydroxystearic acid (2300 mw) propolis wax .alpha.-tocopherol acetate polyglyceryl-4 isostearate water polyglyceryl-2 dipolyhydroxystearate silicon dioxide glycerin white wax polyglyceryl-3 oleate diisostearoyl polyglyceryl-3 dimer dilinoleate argan oil aftersun non nano zinc oxide xylityl sesquicaprylate propolis wax pentylene glycol sodium stearoyl glutamate physalis angulata caprylic/capric/lauric triglyceride aloe vera leaf glyceryl citrate hydrogenated soybean lecithin zinc oxide zinc oxide white wax .alpha.-tocopherol acetate glycerin panthenol cetostearyl alcohol silicon dioxide water butyrospermum parkii (shea) butter unsaponifiables coco-caprylate/caprate sesame oil xanthan gum argan oil diaper rash cream non nano zinc oxide butyrospermum parkii (shea) butter unsaponifiables hydrolyzed jojoba esters (potassium salts) white wax polyglyceryl-3 oleate panthenol coco-caprylate/caprate aloe vera leaf glycerin polyglyceryl-2 dipolyhydroxystearate polyglyceryl-3 diisostearate caprylic/capric/lauric triglyceride .alpha.-tocopherol acetate zinc oxide zinc oxide jojoba oil helianthus annuus seed wax polyglyceryl-4 isostearate polyglycerin-3 palm oil palm kernel oil coconut oil canola oil sunscreen for kids spf50 non nano zinc oxide xylityl sesquicaprylate silicon dioxide polyglyceryl-2 dipolyhydroxystearate polyglyceryl-3 diisostearate magnesium sulfate anhydrous palm kernel oil coconut oil canola oil water coco-caprylate/caprate butyrospermum parkii (shea) butter unsaponifiables argan oil glyceryl citrate propolis wax .alpha.-tocopherol acetate panthenol zinc oxide zinc oxide dicaprylyl carbonate aloe vera leaf cetostearyl alcohol palm oil s.o.s cream intensive moisturizing skin protectant non nano zinc oxide olea europaea flower white wax panthenol honey propolis wax butyrospermum parkii (shea) butter unsaponifiables glycerin olea europaea (olive) oil unsaponifiables water .alpha.-tocopherol acetate, d- royal jelly zinc oxide zinc oxide
Indications and Usage:
Use hand sanitizer to help reduce bacteria that potentially can cause disease. for use when soap and water are not available.
Warnings:
Warnings for external use only. flammable. keep away from heat or flame
Do Not Use:
Warnings for external use only. flammable. keep away from heat or flame
When Using:
When using this product keep out of eyes, ears, and mouth. in case of contact with eyes, rinse eyes thoroughly with water. stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
Dosage and Administration:
Directions place enough product on hands to cover all surfaces. rub hands together until dry. supervise children under 6 years of age when using this product to avoid swallowing.
Stop Use:
Stop use and ask a doctor if irritation or rash occurs. these may be signs of a serious condition.
Package Label Principal Display Panel:
Package label - principal display panel sunscreen spf30 80 ml ndc: 82123-001 sunscreen spf30
Sunscreen for kids spf50 80 ml ndc: 82123-002 sunscreen for kids spf50
Sunscreen for face spf30 40 ml ndc: 82123-003 sunscreen for face spf30
Aftersun 80 ml ndc: 82123-004 aftersun
Diaper rash cream 50 ml ndc: 82123-005 diaper rash cream
Sos cream sos cream