NDC 35192-025 Sun Defense Canyon Ranch

Titanium Dioxide, Octinoxate

NDC Product Code 35192-025

NDC CODE: 35192-025

Proprietary Name: Sun Defense Canyon Ranch What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Titanium Dioxide, Octinoxate 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.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE YELLOWISH)

NDC Code Structure

  • 35192 - Ca-botana International

NDC 35192-025-09

Package Description: 473 g in 1 BOTTLE, PUMP

NDC Product Information

Sun Defense Canyon Ranch with NDC 35192-025 is a a human over the counter drug product labeled by Ca-botana International. The generic name of Sun Defense Canyon Ranch is titanium dioxide, octinoxate. The product's dosage form is emulsion and is administered via topical form.

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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.

Sun Defense Canyon Ranch 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)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • .ALPHA.-BISABOLOL, (+)- (UNII: 105S6I733Z)
  • GLYCINE (UNII: TE7660XO1C)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • MICA (UNII: V8A1AW0880)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
  • ROSEMARY (UNII: IJ67X351P9)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PROLINE (UNII: 9DLQ4CIU6V)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • CETEARYL ISONONANOATE (UNII: P5O01U99NI)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALANINE (UNII: OF5P57N2ZX)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ARGININE, DL- (UNII: FL26NTK3EP)
  • NIACIN (UNII: 2679MF687A)
  • ROSA MOSCHATA OIL (UNII: J99W255AWF)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • VITIS VINIFERA SEED (UNII: C34U15ICXA)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)

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: Ca-botana International
Labeler Code: 35192
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 08-15-2016 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: 12-31-2022 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.

Sun Defense Canyon Ranch Product Label Images

Sun Defense Canyon Ranch 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 Ingredient

Titanium Dioxide 5%...................................SunscreenOctinoxate 4%.............................................Sunscreen

Purpose

Sunscreen

Ask Doctor

Stop use and ask a doctor if rash occurs

Keep Out Of Rech Of Children

Keep out of reach of children

Inactive Ingredients

Water (Aqua), Glycerine, Glyceryl stearate SE, Cetearyl isononanoate, Coco caprylate, Prunus amygdalus dulcis (Sweet Almond) oil, Mica, Caprylic/Capric triglyceride, Cetyl alcohol, Propanediol, Alanine, Aloe barbadensis leaf extract, Arginine, Ascorbic acid, Ascorbyl palmitate, Bisabolol, Cocos nucifera (Coconut) oil, Glycine, Helianthus annuus (Sunflower) seed oil, Niacin, Olea europaea (Olive) leaf , Panthenol, Phospholipids, Potassium sorbate, Proline, Pentylene glycol, Prunus amygdalus dulcis (Sweet Almond) oil, Rosa canina (Rosehip) oil, Rosmarinus officinalis leaf (Rosemary), Sodium hyaluronate, Sodium citrate, Sorbitan monostearate, Tetrasodium EDTA, Tocopherol, Urea,Vitis vinifera (Grape) seed, Xanthan gum, Citric acid, Ethylhexylglycerin, Phenoxyethanol

Safety Information

Protect this product from excessive heat and direct sun

Dosage & Administration

Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Usea water resistant sunscreen if swimming or sweating. Reapply : at least 2 hours. Children under 6 months: Ask a doctor. Sun protections measurements. 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 of 15 or higher and othe sun protection measures including: limit time in the sun, specially from 10 a.m.- 2 p.m Wear long-sleeveshirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct 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. If product is swallowed get medical help or contact a poison Control Center right away.

Indications & Usage

Apply liberally 15 minutes before exposure, use water resistant sunscreen, if swimming or sweating. reapply at least every 2 hours. Children under 6 months: ask a doctor

* Please review the disclaimer below.