NDC 72600-150 Esmia Bb Caramel 31

Titanium Dioxide, Octinoxate, Octisalate

NDC Product Code 72600-150

NDC 72600-150-02

Package Description: 1 CONTAINER in 1 CARTON > 40 mL in 1 CONTAINER (72600-150-01)

NDC Product Information

Esmia Bb Caramel 31 with NDC 72600-150 is a a human over the counter drug product labeled by Bs Cosmetics Co.,ltd.. The generic name of Esmia Bb Caramel 31 is titanium dioxide, octinoxate, octisalate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bs Cosmetics Co.,ltd.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Esmia Bb Caramel 31 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • TITANIUM DIOXIDE 3.74 g/40mL
  • OCTINOXATE 2 g/40mL
  • OCTISALATE .8 g/40mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bs Cosmetics Co.,ltd.
Labeler Code: 72600
FDA Application Number: part352 What is the FDA Application Number?
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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 09-01-2018 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Esmia Bb Caramel 31 Product Label Images

Esmia Bb Caramel 31 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Active ingredients: Titanium Dioxide 9.36%, Ethylhexyl Methoxycinnamate 5.00%, Ethylhexyl Salicylate 2.00%

Inactive Ingredient

Inactive ingredients:Water,Propylene Glycol,Mineral Oil,Caprylic/Capric Triglyceride,Cetyl Ethylhexanoate,Niacinamide,Cetyl PEG/PPG-10/1 Dimethicone,Dimethicone,Cyclopentasiloxane,Glycerin,Sorbitan SesquioleateMagnesium Sulfate,Microcrystalline Wax,Mica (CI 77019),Phenyl Trimethicone,Aluminum Hydroxide,Cyclohexasiloxane,Disteardimonium HectoriteDimethicone/Vinyl Dimethicone Crosspolymer,Caprylyl Glycol,Butylene Glycol,Silica Dimethyl Silylate,Zinc Stearate,Triethoxycaprylylsilane,Stearic AcidPEG-10 Dimethicone Crosspolymer,Tocopheryl Acetate,Allantoin,Caprylhydroxamic Acid,PEG-10 Dimethicone,Sodium Citrate,HydroxyethylcelluloseAloe Barbadensis Leaf Juice,Bisabolol,Butyrospermum Parkii (Shea Butter),Macadamia Ternifolia Seed Oil,Simmondsia Chinensis (Jojoba) Seed OilAdenosine,Argania Spinosa Kernel Oil,Farnesol,Farnesyl Acetate,Helianthus Annuus (Sunflower) Seed Oil,Panthenyl Triacetate,Sodium HyaluronateSophora Japonica Fruit Extract,Ceramide NP,Hydrogenated Lecithin,Iron Oxides (CI 77492),Iron Oxides (CI 77491),Iron Oxides (CI 77499),Fragrance)

Purpose

Purpose: Sunscreen

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 product is swallowed, get medical help or contact a Poison Control Center right away.

Description

Uses:Helps prevent sunburnDirections:Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

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