NDC 61352-004 Total Sun Protection
Octinoxate,Octisalate,Oxybenzone,Zinc Oxide Lotion Topical - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 61352 - Cosmed Dermaceuticals, Inc.
- 61352-004 - Total Sun Protection
Product Packages
NDC Code 61352-004-01
Package Description: 127.6 g in 1 BOTTLE, PLASTIC
Product Details
What is NDC 61352-004?
What are the uses for Total Sun Protection?
What are Total Sun Protection Active Ingredients?
- OCTINOXATE 75 mg/g
- OCTISALATE 30 mg/g
- OXYBENZONE 30 mg/g
- ZINC OXIDE 40 mg/g - A mild astringent and topical protectant with some antiseptic action. It is also used in bandages, pastes, ointments, dental cements, and as a sunblock.
Which are Total Sun Protection UNII Codes?
The UNII codes for the active ingredients in this product are:
- OCTINOXATE (UNII: 4Y5P7MUD51)
- OCTINOXATE (UNII: 4Y5P7MUD51) (Active Moiety)
- OCTISALATE (UNII: 4X49Y0596W)
- OCTISALATE (UNII: 4X49Y0596W) (Active Moiety)
- OXYBENZONE (UNII: 95OOS7VE0Y)
- OXYBENZONE (UNII: 95OOS7VE0Y) (Active Moiety)
- ZINC OXIDE (UNII: SOI2LOH54Z)
- ZINC CATION (UNII: 13S1S8SF37) (Active Moiety)
Which are Total Sun Protection Inactive Ingredients UNII Codes?
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. The UNII codes for the inactive ingredients in this product are:
- WATER (UNII: 059QF0KO0R)
- ALOE VERA LEAF (UNII: ZY81Z83H0X)
- PPG-3 MYRISTYL ETHER (UNII: 7913J43WZ5)
- GLYCOL STEARATE (UNII: 0324G66D0E)
- CETYL ALCOHOL (UNII: 936JST6JCN)
- POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
- HEXADECYL POVIDONE (4 HEXADECYL BRANCHES/REPEAT) (UNII: AG75W62QYU)
- CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
- CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
- .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
- PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
- C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
- DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- CETYL PHOSPHATE (UNII: VT07D6X67O)
- GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
- PEG-100 STEARATE (UNII: YD01N1999R)
- GLYCERIN (UNII: PDC6A3C0OX)
- DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
- TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
- METHYLPARABEN (UNII: A2I8C7HI9T)
- EDETATE DISODIUM (UNII: 7FLD91C86K)
- PROPYLPARABEN (UNII: Z8IX2SC1OH)
- LAURETH-7 (UNII: Z95S6G8201)
Which are the Pharmacologic Classes for Total Sun Protection?
* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] 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.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] 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.
[8] 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.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] 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.
[12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".