NDC 69711-340 Derma Soleil Mineral Broad Spectrum Spf 30 Sunscreen

Titanium Dioxide,zinc Oxide

NDC Product Code 69711-340

NDC Code: 69711-340

Proprietary Name: Derma Soleil Mineral Broad Spectrum Spf 30 Sunscreen 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,zinc Oxide 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.

NDC Code Structure

  • 69711 - Derma Soleil
    • 69711-340 - Derma Soleil Mineral Broad Spectrum Spf 30 Sunscreen

NDC 69711-340-01

Package Description: 100 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Derma Soleil Mineral Broad Spectrum Spf 30 Sunscreen with NDC 69711-340 is a a human over the counter drug product labeled by Derma Soleil. The generic name of Derma Soleil Mineral Broad Spectrum Spf 30 Sunscreen is titanium dioxide,zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Derma Soleil

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.

Derma Soleil Mineral Broad Spectrum Spf 30 Sunscreen 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.

  • ZINC OXIDE 11 g/100mL
  • TITANIUM DIOXIDE 8 g/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.

  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
  • COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
  • WATER (UNII: 059QF0KO0R)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • FYTIC ACID (UNII: 7IGF0S7R8I)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Derma Soleil
Labeler Code: 69711
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: 06-11-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Derma Soleil Mineral Broad Spectrum Spf 30 Sunscreen 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

Otc - Purpose

Sunscreen

Micronized Zinc Oxide 10%..............SunscreenMicronized Titanium Dioxide 6%..............Sunscreen

Sunscreen

Sunscreen

Otc - Active Ingredient

Micronized Zinc Oxide 16%Micronized Titanium Dioxide 8%

Micronized Zinc 10%Micronized Titanium Dioxide 6%

Micronized Zinc Oxide 16%Micronized Titanium Dioxide 9%

Micronized Zinc Oxide 11%Micronized Titanium Dioxide 8%

Indications & Usage

The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years reduces the chance of these harmful effects.Helps prevent sunburnIf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by sun

The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years reduces the chance of these harmful effects.Helps prevent sunburnIf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by sun

The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years reduces the chance of these harmful effects.Helps prevent sunburnIf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by sun

The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and regular use of sunscreens over the years reduces the chance of these harmful effects.Helps prevent sunburnIf used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by 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 consult a doctor if rash occurs.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

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 consult a doctor if rash occurs.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

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 consult a doctor if rash occurs.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

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 consult a doctor if rash occurs.Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Apply liberally 15 minutes before sun exposureReapplyAfter 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursChildren under 6 months of age: ask a doctor

Apply liberally 15 minutes before sun exposureReapplyAfter 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursChildren under 6 months of age: ask a doctor

Apply liberally 15 minutes before sun exposureReapplyAfter 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursChildren under 6 months of age: ask a doctor

Apply liberally 15 minutes before sun exposureReapplyAfter 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursChildren under 6 months of age: ask a doctor

Inactive Ingredient

Water, Coco-Caprylate, Dicaprylyl Carbonate, Lauryl Glucoside,Polyglyceryl-2 Dipolyhydroxystearate, Glycerin, Microcrystalline Cellulose,Cellulose Gum, Green Tea Extract, DL-Panthenol, Sodium Ascorbyl Phosphate,D-alpha Tocopheryl Acetate, Phytic Acid, Triethoxycaprylylsilane, Polyhydroxystearic Acid,Xanthan Gum, Benzyl Alcohol, Ethylhexylglycerin, D-alpha Tocopherol

Aqua, Aloe barbadensis Leaf Juice, Grape Seed Oil, Glycerine, Jojoba Oil,Caprylic/Capric Triglyceride, Cetearyl Olivate, Sorbitan Olivate, Salicylic Acid, Sorbic Acid,Cetearyl Alcohol, Citric Acid, Calendula officinalis Seed Oil, Glyceryl Isostearate, Polyhydroxystearic Acid, Evening Primrose Oil, Mica, Mauritia flexuosa Fruit Oil, Aluminum Hydroxide,Lauric Acid, Tapioca, Iron Oxide Yellow, Potassium Sorbate, Aminoprypyl Ascorbyl Phosphate,Disodium Lauriminodipropionate Tocopheryl Phosphates, Xanthan Gum, Sodium Benzoate

Aqua, Aloe barbadensis Leaf Juice, Grape Seed Oil, Glycerine, Jojoba Oil,Caprylic/Capric Triglyceride, Cetearyl Olivate, Sorbitan Olivate, Salicylic Acid, Sorbic Acid,Cetearyl Alcohol, Citric Acid, Calendula officinalis Seed Oil, Glyceryl Isostearate,Polyhydroxystearic Acid, Evening Primrose Oil, Mica, Mauritia flexuosa Fruit Oil, Aluminum Hydroxide,Lauric Acid, Tapioca, Iron Oxide Yellow, Potassium Sorbate, Aminoprypyl Ascorbyl Phosphate,Disodium Lauriminodipropionate Tocopheryl Phosphates, Xanthan Gum, Sodium Benzoate

Water, Coco-Caprylate, Dicaprylyl Carbonate, Lauryl Glucoside,Polyglyceryl-2 Dipolyhydroxystearate, Glycerin, Microcrystalline Cellulose,Cellulose Gum, Green Tea Extract, DL-Panthenol, Sodium Ascorbyl Phosphate,D-alpha Tocopheryl Acetate, Phytic Acid, Triethoxycaprylylsilane, Polyhydroxystearic Acid,Xanthan Gum, Benzyl Alcohol, Ethylhexylglycerin, D-alpha Tocopherol

* Please review the disclaimer below.

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