NDC 0316-2064 Blue Lizard Sheer Spf 50 Sunscreen

Titanium Dioxide, Zinc Oxide

NDC Product Code 0316-2064

NDC 0316-2064-30

Package Description: 1 TUBE in 1 CARTON > 89 mL in 1 TUBE

NDC Product Information

Blue Lizard Sheer Spf 50 Sunscreen with NDC 0316-2064 is a a human over the counter drug product labeled by Crown Laboratories. The generic name of Blue Lizard Sheer Spf 50 Sunscreen is titanium dioxide, 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 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.

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

  • GLYCERIN (UNII: PDC6A3C0OX)
  • HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
  • GINKGO (UNII: 19FUJ2C58T)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • ALUMINUM STEARATE (UNII: U6XF9NP8HM)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • PAPAYA (UNII: KU94FIY6JB)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • ORANGE PEEL (UNII: TI9T76XD44)
  • CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)
  • CUCUMBER (UNII: YY7C30VXJT)
  • DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
  • DIMETHOXYDIPHENYLSILANE (UNII: 02QB6788GC)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • FUCUS VESICULOSUS (UNII: 535G2ABX9M)
  • .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
  • HYDROGENATED PALM OIL (UNII: 257THB963H)
  • HYDROGENATED RAPESEED OIL (UNII: K168T6Y0YU)
  • ISOSTEARYL ISOSTEARATE (UNII: IV0Z586Z4Y)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • WATER (UNII: 059QF0KO0R)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SQUALANE (UNII: GW89575KF9)

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: 05-06-2021 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 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 risk of skin cancer and early skin aging caused by the sun

Warnings

  • When using this productKeep out of eyes. Rinse with water to removeStop use and ask a doctor ifRash or irritation occursDo not useOn damaged or broken skinIf allergic to any ingredientIf swallowed, get medical help or contact a Poison Control Center

Directions

  • Shake well prior to useApply liberally to dry skin 15 minutes before sun exposureFor topical use onlyKeep out of reach of childrenChildren under 6 months: ask a doctorSun 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 sweatingimmediately after towel dryingat least every 2 hours

Other Information

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

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Alumina, Aluminum Stearate, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Carcia Papaya (Papaya) Fruit Extract, Citric Acid, Citrus Aurantium Dulcis (Orange) Peel Extract, Crithmum Maritimum Extract, Cucumis Sativus (Cucumber) Fruit Extract, Diisopropyl Sebacate, Dimethoxydiphenylsilane/Triethoxycaprylylsilane Crosspolymer, Ethylhexylglycerin, Fucus Vesiculosus (Bladderwrack) Extract, Gamma-Nonalactone, Gingko Biloba (Ginkgo) Leaf Extract, Glycerin, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Hydrogenated Vegetable Oil, Isostearyl Alcohol, Isostearyl Isostearate, Phenoxyethanol, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Potassium Sorbate, Purified Water, Ricinus Communis (Castor) Seed Oil, Rosa Canina (Rosehip) Fruit Oil, Sclerocarya Birrea (Marula) Seed Oil, Sea Water, Sodium Benzoate, Sodium Chloride, Sorbitan Isostearate, Squalane, Tocopheryl Acetate (Vitamin E), Triethyl Citrate, and Xanthan Gum

Questions?

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

Blue Lizard Sheer Lotion - Tube Label

BLUE LIZARDAUSTRALIAN SUNSCREEN50+Sheer Lotionmineral sunscreenUVA/UVB PROTECTIONBROAD SPECTRUMSPF 50+WATER RESISTANT (80 MINUTES)P11899.00

Blue Lizard Sheer Lotion - 3Oz Carton

BLUE LIZARDAUSTRALIAN SUNSCREEN50+Sheer Lotionmineral sunscreenUVA/UVB PROTECTIONBROAD SPECTRUMSPF 50+WATER RESISTANT (80 MINUTES)P11902.00

* Please review the disclaimer below.