NDC 0316-2057 Blue Lizard Sheer Face Spf 50 Sunscreen

Titanium Dioxide And Zinc Oxide

NDC Product Code 0316-2057

NDC CODE: 0316-2057

Proprietary Name: Blue Lizard Sheer Face Spf 50 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 And 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

  • 0316 - Crown Laboratories
    • 0316-2057 - Blue Lizard Sheer Face Spf 50 Sunscreen

NDC 0316-2057-17

Package Description: 1 TUBE in 1 CARTON > 48 mL in 1 TUBE

NDC Product Information

Blue Lizard Sheer Face Spf 50 Sunscreen with NDC 0316-2057 is a a human over the counter drug product labeled by Crown Laboratories. The generic name of Blue Lizard Sheer Face Spf 50 Sunscreen is titanium dioxide and zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Crown Laboratories

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.

Blue Lizard Sheer Face Spf 50 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.

  • TITANIUM DIOXIDE 99.9 mg/mL
  • ZINC OXIDE 66.6 mg/mL

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.

  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • THREONINE (UNII: 2ZD004190S)
  • VALINE (UNII: HG18B9YRS7)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WATER (UNII: 059QF0KO0R)
  • SERINE (UNII: 452VLY9402)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ALUMINUM STEARATE (UNII: U6XF9NP8HM)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • FUCUS VESICULOSUS (UNII: 535G2ABX9M)
  • GINKGO (UNII: 19FUJ2C58T)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCINE (UNII: TE7660XO1C)
  • HISTIDINE (UNII: 4QD397987E)
  • ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
  • HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • RICE GERM (UNII: 7N2B70SFEZ)
  • PIDOLIC ACID (UNII: SZB83O1W42)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • PAPAYA (UNII: KU94FIY6JB)
  • CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CUCUMBER (UNII: YY7C30VXJT)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • PHENYLALANINE (UNII: 47E5O17Y3R)
  • ISOLEUCINE (UNII: 04Y7590D77)
  • ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
  • SQUALANE (UNII: GW89575KF9)
  • SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
  • ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
  • PROLINE (UNII: 9DLQ4CIU6V)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
  • HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • ASPARTIC ACID (UNII: 30KYC7MIAI)
  • DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)
  • HYDROGENATED PALM OIL (UNII: 257THB963H)
  • ALANINE (UNII: OF5P57N2ZX)
  • ARGININE (UNII: 94ZLA3W45F)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)

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: Crown Laboratories
Labeler Code: 0316
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: 05-13-2021 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.

Blue Lizard Sheer Face Spf 50 Sunscreen Product Label Images

Blue Lizard Sheer Face Spf 50 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

Active Ingredients

Titanium Dioxide - 9%Zinc Oxide - 6%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn and photodamage caused by UVA/UVB exposureHigher SPF gives more sunburn protectionIf used as directed with other sun protection measures (see
  • Directions), decreases the risks of skin cancer and early skin aging caused by the sun

Warnings

• When using this product • Keep out of eyes. Rinse with water to remove• Stop use and ask doctor if • Rash or irritation occurs• Do not use • On damaged or broken skin • If allergic to any ingredient• If swallowed, get medical help or contact a Poison Control Center

Directions


Shake well prior to use• Apply liberally to dry skin 15 minutes before sun exposure• For topical use only• Keep out of reach of children • Children under 6 months: 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.•
Reapply to dry skin: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours

Other Information

  • Protect the product in this container from excessive heat and direct sunMay stain some fabrics

Inactive Ingredients

Alanine, Aloe Barbadensis Leaf Juice, Alumina, Aluminum Stearate, Arginine, Aspartic Acid, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carcia Papaya (Papaya) Fruit Extract, Citric Acid, Crithmum Maritimum Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diisopropyl Sebacate, Dimethoxydiphenylsilane/ Triethoxycaprylylsilane Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus (Bladderwrack) Extract, Gingko Biloba (Ginkgo) Leaf Extract, Glycerin, Glycine, Glycine Soja (Soybean) Oil, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Histidine, Hydrogenated Vegetable Oil, Isoleucine, Isostearyl Alcohol, Isostearyl Isostearate, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, PCA, Phenoxyethanol, Phenylalanine, Polyglyceryl-3 Diisostearate, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Potassium Sorbate, Proline, Purified Water, Rosa Canina (Rosehip) Fruit Oil, Sclerocarya Birrea (Marula) Seed Oil, Serine, Sodium Benzoate, Sodium Chloride, Sodium Hyaluronate, Sodium Lactate, Sodium PCA, Sorbitan Isostearate, Squalane, Threonine, Tocopheryl Acetate (Vitamin E), Valine, and Xanthan Gum

Questions ?

Visit
www.bluelizardsunscreen.com or call
800.877.8869Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Sheer Lotion For Face - 1.7 Fl Oz Tube

BLUE LIZARDAUSTRALIAN SUNSCREEN50+SHEER LOTION for faceMINERAL SUNSCREENUVA/UVB PROTECTIONBROAD SPECTRUMSPF 50+WATER RESISTANT (80 MINUTES)

Blue Lizard Sheer Lotion For Face - 1.7 Fl Oz Carton

BLUE LIZARDAUSTRALIAN SUNSCREEN50+SHEER LOTION for faceMINERAL SUNSCREENUVA/UVB PROTECTIONBROAD SPECTRUMSPF 50+WATER RESISTANT (80 MINUTES)

* Please review the disclaimer below.