NDC 61477-219 Aloe Up Sport Natural Balm Spf-15

Avobenzone, Octinoxate, Octisalate, Octocrylene

NDC Product Code 61477-219

NDC CODE: 61477-219

Proprietary Name: Aloe Up Sport Natural Balm Spf-15 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: Avobenzone, Octinoxate, Octisalate, Octocrylene 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

  • 61477 - Aloe Care International, Llc

NDC 61477-219-11

Package Description: 4.25 g in 1 TUBE

NDC Product Information

Aloe Up Sport Natural Balm Spf-15 with NDC 61477-219 is a a human over the counter drug product labeled by Aloe Care International, Llc. The generic name of Aloe Up Sport Natural Balm Spf-15 is avobenzone, octinoxate, octisalate, octocrylene. The product's dosage form is stick and is administered via topical form.

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.

Aloe Up Sport Natural Balm Spf-15 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.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CANOLA OIL (UNII: 331KBJ17RK)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
  • LANOLIN (UNII: 7EV65EAW6H)
  • MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: Aloe Care International, Llc
Labeler Code: 61477
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: 02-24-2014 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: 12-31-2021 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.

Aloe Up Sport Natural Balm Spf-15 Product Label Images

Aloe Up Sport Natural Balm Spf-15 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

Avobenzone (2%)Octinoxate (6.5%)Octisalate (5%)Octocrylene (1.5%)

Purpose

SUNSCREEN

Uses

  • HELPS PREVENT SUNBURN.

Directions

  • APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING.REAPPLY AT LEAST EVERY 2 HOURS.CHILDREN UNDER 6 MONTHS: ASK A DOCTOR.

Otc - Keep Out Of Reach Of Children

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

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.For external use onlyDo not use on damaged or broken skinStop use and ask a doctor if rash occursWhen using this product keep out of eyes. Rinse with water to remove.

Inactive Ingredients

Aloe Vera Leaf Extract, Avocado Oil, Beeswax, BHT, Canola Oil, Caprylic/Capric Triglyceride, Castor Seed Oil, Coconut Oil,Hydrogenated Vegetable Oil, Lanolin Oil, Mango Butter, Sunflower Seed Oil, Tocopherol, Tocopheryl Acetate.

Other Information

  • Protect this product from excessive heat and direct sun

* Please review the disclaimer below.