NDC 0316-2011 Blue Lizard Baby Spf 50

Zinc Oxide

NDC Product Code 0316-2011

NDC Product Information

Blue Lizard Baby Spf 50 with NDC 0316-2011 is a a human over the counter drug product labeled by Crown Laboratories. The generic name of Blue Lizard Baby Spf 50 is zinc oxide. The product's dosage form is stick and is administered via topical form.

Labeler Name: Crown Laboratories

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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 Baby Spf 50 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 20 mg/g

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.

  • BEHENYL BEHENATE (UNII: K8NU647RJ0)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • .ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9)
  • JOJOBA OIL (UNII: 724GKU717M)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • SQUALANE (UNII: GW89575KF9)
  • SHEA BUTTER (UNII: K49155WL9Y)

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.
  • 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: 11-25-2019 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.

Blue Lizard Baby Spf 50 Product Label Images

Blue Lizard Baby Spf 50 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

Zinc Oxide - 20%

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 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

• Apply liberally to dry skin 15 minutes before sun exposure• For topical use only• Keep out of reach of children • 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 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

Aloe Barbadensis Leaf Extract, Behenyl Behenate, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Polyhydroxystearic Acid, Ricinus Communis (Castor) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Squalane, Theobroma Cacao (Cocoa) Seed Butter, Tocopherol

Questions?

Visit
www.bluelizard.net or call
800.877.8869Distributed by Crown Laboratories, Inc., Johnson City, TN 37604

Blue Lizard Baby Spf 50+ Stick Label

BLUE LIZARDAUSTRALIAN SUNSCREEN50+UVA/UVB PROTECTIONBROAD SPECTRUMSPF 50+Babymineral sunscreen stickWater Resistant (80 Minutes)P11671.00

Blue Lizard Baby Spf 50+ Stick Card

P11673.00

* Please review the disclaimer below.