NDC 54111-140 Meow Meow Tweet Everyday Sunscreen Spf 25

Zinc Oxide

NDC Product Code 54111-140

NDC 54111-140-50

Package Description: 1 BOTTLE, PUMP in 1 PACKAGE > 80 mL in 1 BOTTLE, PUMP

NDC Product Information

Meow Meow Tweet Everyday Sunscreen Spf 25 with NDC 54111-140 is a a human over the counter drug product labeled by Bentley Laboratories Llc. The generic name of Meow Meow Tweet Everyday Sunscreen Spf 25 is zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Bentley Laboratories Llc

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.

Meow Meow Tweet Everyday Sunscreen Spf 25 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/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.

  • WATER (UNII: 059QF0KO0R)
  • JOJOBA OIL (UNII: 724GKU717M)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • SQUALANE (UNII: GW89575KF9)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • LACTOBACILLUS REUTERI (UNII: 9913I24QEE)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)
  • SODIUM LEVULINATE (UNII: VK44E1MQU8)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • TOCOPHEROL (UNII: R0ZB2556P8)

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: Bentley Laboratories Llc
Labeler Code: 54111
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: 08-30-2019 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’.

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Meow Meow Tweet Everyday Sunscreen Spf 25 Product Label Images

Meow Meow Tweet Everyday Sunscreen Spf 25 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

Other

DRUG FACTS

Otc - Active Ingredient

Active IngredientsZinc Oxide @ 20%

Otc - Purpose

PurposeSunscreen

Indications & Usage

Uses•helps prevent sunburn•if used as directed with other  sun protection measures (see Directions),  decreases the risk of skin cancer and  early skin aging caused by the sun.

Directions• apply liberally 15 minutes before sun exposure.• reapply: • after swimming or excessive sweating;• at least every 2 hours; • immediately after towel drying.• children under 6 months, consult a doctor

Warnings And Precautions

WarningsFor external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this productkeep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If product is swallowed, get medical help orcontact a Poison Control Center right away.

Other Safety Information

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 valueof 15 or higher and other sun protection measures including:• Limit time in the sun, especially from 10 a.m. to 2 p.m.• Wear long-sleeved shirts, pants, hats, and sunglasses.

Other InformationProtect the product in this container from excessive heat and direct sun.

Inactive Ingredient

Inactive IngredientsWater/Aqua, *Simmondsia Chinensis (Jojoba) Seed Oil, *CarthamusTinctorius (Safflower) Seed Oil, *Glycerin, Cetearyl Olivate, Squalane,Lactic Acid, Sorbitan Olivate, Lactobacillus Ferment, *Aloe BarbadensisLeaf Juice, *Cocos Nucifera (Coconut) Oil, Pelargonium GraveolensFlower Oil, Polyhydroxystearic Acid, Sodium Levulinate, Xanthan Gum,Potassium Sorbate, Helianthus Annuus (Sunflower) Seed Wax, AscorbylPalmitate, Tocopherol*certified organic

Package Labeling

Retail PackageBottlerege

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