NDC 71305-700 Satin Foundation Spf 15

Satin Foundation Spf 15

NDC Product Code 71305-700

NDC 71305-700-10

Package Description: 1 BOTTLE in 1 BOX > 30 mL in 1 BOTTLE

NDC Product Information

Satin Foundation Spf 15 with NDC 71305-700 is a a human over the counter drug product labeled by Modern Basic Cosmetics Ltd. The generic name of Satin Foundation Spf 15 is satin foundation spf 15. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Modern Basic Cosmetics Ltd

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Satin Foundation Spf 15 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.

  • OCTINOXATE 2.5 mg/100mL
  • TITANIUM DIOXIDE 10 mg/100mL

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.

  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • WATER (UNII: 059QF0KO0R)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CHROMIC OXIDE (UNII: X5Z09SU859)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • MAGNESIUM PALMITATE (UNII: JJ0UR696JR)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)

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: Modern Basic Cosmetics Ltd
Labeler Code: 71305
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: 12-16-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-01-2024 What is the End Marketing Date?
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.

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’.

* Please review the disclaimer below.

Satin Foundation Spf 15 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

Titanium dioxide, 10%ethylhexyl methoxycinnamate, 2.5%

Purpose:

- suncreen- helps prevent sunburn




- if used as directed with other sun protection measures (see directions), it decreases the risk of skin cancer and early skin aging caused by the sun

When Using:

For external use only




Do not use on damaged or broken skin




Remove with water and mild cleanser

Do Not Use:

- do not use on damaged or broken skin

Ask Doctor:

- stop use and ask doctor if rash occurs

Keep Out Of Reach Of Children

- keep out of reach of children. if swallowed, get medical help or contact a poison control center right away

Directions

*apply liberally 15 minutes before sun exposure

*reapply after 40 minutes of swimming or sweating

*reapply immediately after towel drying

*reapply at least every 2 hours
*Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging, To decrease risk, regulary 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 10am-2 pm

*wear long-sleeved shirts, pants, hats and sunglasses

*children under 6 months of age: Ask a doctor

Inactive Ingredients:

Aqua, cyclopentasiloxane, disteardimonium hectorite, Propylene Carbonate, Butylene Glycol, Dimethicone Dimethicone/vinyl Dimethicone crosspolymer, trimethylsiloxysilicate, ethylhexyl methoxycinnamate, PEG-10 dimethicone, sodium chloride, silica, methicone, polymethyl methacrylate, magnesium stearate, magnesium palmitate, sorbitan sesquioleate, lauryl PEG/PPG-18/18 methicone, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, disodium EDTA, sodium hyaluronate, xanthan gum, tribehenin, propylene glycol, diazolidinyl urea, iodopropynyl butylcarbamate, may contain phenoxyethanol, triethoxycaprylsilane, titanium dioxide, CI 77492, CI 77491, CI 77288, CI 77499

Other Information:

Protect this product from excessive heat and direct sun

Questions:

Call toll free 1-877-438-1120

* Please review the disclaimer below.