Itc Bye Bye Foundation Full Coverage Moisturizer Light Medium
Titanium Dioxide, Zinc Oxide
Beauty Manufacturing Solutions Corp.
Human Otc Drug
NDC 11090-117Itc Bye Bye Foundation Full Coverage Moisturizer Light Medium also known as Titanium Dioxide, Zinc Oxide is a human otc drug labeled by 'Beauty Manufacturing Solutions Corp.'. National Drug Code (NDC) number for Itc Bye Bye Foundation Full Coverage Moisturizer Light Medium is 11090-117. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Itc Bye Bye Foundation Full Coverage Moisturizer Light Medium drug includes Titanium Dioxide - 90 mg/mL Zinc Oxide - 63 mg/mL . The currest status of Itc Bye Bye Foundation Full Coverage Moisturizer Light Medium drug is Active.
Drug Information:
| Drug NDC: | 11090-117 |
| 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: | Itc Bye Bye Foundation Full Coverage Moisturizer Light Medium |
| 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: | Beauty Manufacturing Solutions Corp. |
| 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 - 90 mg/mL
ZINC OXIDE - 63 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 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: | 01 Nov, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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: | Beauty Manufacturing Solutions Corp.
|
| 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 |
|---|
| 11090-117-01 | 1 TUBE in 1 CARTON (11090-117-01) / 30 mL in 1 TUBE | 01 Nov, 2020 | N/A | No |
| 11090-117-02 | 1 TUBE in 1 CARTON (11090-117-02) / 75 mL in 1 TUBE | 01 Nov, 2020 | 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:
Sunscreen
Product Elements:
Itc bye bye foundation full coverage moisturizer neutral medium titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer medium tan titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer light medium titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer rich honey titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer medium titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer tan titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer fair titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer rich titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer neutral tan titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer deep titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer fair light titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate itc bye bye foundation full coverage moisturizer light titanium dioxide, zinc oxide adenosine sodium benzoate glycerin lime oil eucalyptus oil water ferric oxide red butyloctyl salicylate hexyl laurate aluminum hydroxide babassu oil green tea leaf pine needle oil (pinus sylvestris) butylene glycol dicaprylate/dicaprate n-hydroxysuccinimide cyclomethicone 5 lactobacillus fermentum bergamot oil chrysin coconut butylene glycol polymethylsilsesquioxane (4.5 microns) diamond phenyl trimethicone phenoxyethanol lemon oil cyclomethicone 6 edetate disodium orange oil asian ginseng leuconostoc/radish root ferment filtrate magnesium sulfate, unspecified ferric oxide yellow dimethicone/vinyl dimethicone crosspolymer (hard particle) steareth-20 triethoxycaprylylsilane chlorhexidine gluconate ferrosoferric oxide olea europaea leaf xanthan gum niacinamide adzuki bean stearic acid palmitoyl tetrapeptide-7 palmitoyl tripeptide-1 hyaluronic acid 1,2-hexanediol cetyl peg/ppg-10/1 dimethicone (hlb 5) caprylyl glycol ethylhexylglycerin calcium stearate titanium dioxide titanium dioxide zinc oxide zinc oxide sorbitan isostearate gelatin hydrolysate (porcine skin, mw 3000) potassium sorbate polyglyceryl-4 isostearate dimethicone alpha-tocopherol acetate
Warnings:
For external use only
Do Not Use:
For external use only
When Using:
Keep out of eyes. rinse with water to remove
Dosage and Administration:
Apply liberally 15 minutes before sun exposure â reapply at least every 2 hours â use a water resistant sunscreen if swimming or sweating â sun protection measures. spending time in the sun increases your risk of skin cancer and early skin aging. to decrease this risk, regularly use a sunscreen with a broad spectrum spf value of 15 or higher and other sun protection measures including: â limit time in the sun, especially from 10 a.m. â 2 p.m. â wear long-sleeved shirts, pants, hats, and sunglasses â children under 6 months of age: ask a doctor
Stop Use:
Rash occurs
Package Label Principal Display Panel:
Principle display panel
Principle display panel
Principle display panel
Principle display panel
Principle display panel
Principle display panel
Principle display panel
Principle display panel
Principle display panel
Principle display panel
Principle display panel
Principle display panel
Further Questions:
Call 800-620-3950