NDC 66097-008 Tinted Sunscreen Spf 30 2-golden

Titanium Dioxide, Zinc Oxide

NDC Product Code 66097-008

NDC 66097-008-40

Package Description: 1 TUBE in 1 BOX > 40 mL in 1 TUBE

NDC Product Information

Tinted Sunscreen Spf 30 2-golden with NDC 66097-008 is a a human over the counter drug product labeled by C.f.e.b. - Sisley. The generic name of Tinted Sunscreen Spf 30 2-golden is titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

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.

Tinted Sunscreen Spf 30 2-golden 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.


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)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • CAMELLIA OIL (UNII: T1PE06G0VE)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • THYMUS MASTICHINA FLOWERING TOP OIL (UNII: 9NP0832457)
  • SAGE OIL (UNII: U27K0H1H2O)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)

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: C.f.e.b. - Sisley
Labeler Code: 66097
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: 12-23-2015 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 - NO 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".

* Please review the disclaimer below.

Tinted Sunscreen Spf 30 2-golden Product Label Images

Tinted Sunscreen Spf 30 2-golden 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 14.74%





Zinc oxide 10.89%

Purpose

Sunscreen

Uses

■ Helps prevent sunburn.





■ If used as directed with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging caused by the sun.

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.

Directions

■ Apply liberally 15 minutes before sun exposure.





■ Reapply:





  ■ After 40 minutes of swimming or sweating.





  ■ Immediately after towel drying.





  ■ At least every 2 hours.





■ Children under 6 months of age: ask a doctor.











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 Broad Spectrum SPF value of 15 or higher and other sun protection measures including:





  ■ Limit time in the sun, especially from 10 am to 2 pm.





  ■ Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

Protect the product in the container from excessive heat or direct sun.

Inactive Ingredients

Water, C9-12 alkane, caprylyl methicone, glycerin, polyglyceryl-3 diisostearate, silica, butyrospermum parkii (shea) butter, polyglyceryl-4 isostearate, cetyl peg/ppg-10/1 dimethicone, hexyl laurate, camellia oleifera seed oil, sodium chloride, tocopheryl acetate, leontopodium alpinum extract, mangifera indica (mango) fruit extract, thymus mastichina flower oil, salvia officinalis (sage) oil, alumina, synthetic fluorphlogopite, hydrogenated lecithin, dimethicone, disodium edta, glyceryl caprylate, ethylhexylglycerin, triethoxycaprylylsilane, citric acid, sodium citrate, benzoic acid, sodium benzoate, potassium sorbate, iron oxides, linalool, limonene.

* Please review the disclaimer below.