NDC 61477-214 Aloe Up Natural Lip Ice Sunscreen

Octinoxate, Oxybenzone

NDC Product Code 61477-214

NDC 61477-214-14

Package Description: 4.25 g in 1 TUBE

NDC Product Information

Aloe Up Natural Lip Ice Sunscreen with NDC 61477-214 is a a human over the counter drug product labeled by Aloe Care International, Llc. The generic name of Aloe Up Natural Lip Ice Sunscreen is octinoxate, oxybenzone. The product's dosage form is lipstick and is administered via topical form.

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

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 Natural Lip Ice 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.


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)
  • YELLOW WAX (UNII: 2ZA36H0S2V)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • HYDROGENATED SOYBEAN OIL (UNII: A2M91M918C)
  • LANOLIN (UNII: 7EV65EAW6H)
  • MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • 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 Natural Lip Ice 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

Otc - Active Ingredient

ACTIVE INGREDIENTS:OCTINOXATE (%)OXYBENZONE (4.5%)

Otc - Purpose

PURPOSE:SUNSCREEN

Indications & Usage

INDICATIONS:HELPS PREVENT SUNBURN.

Dosage & Administration

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.

Warnings

WARNINGS:FOR EXTERNAL USE ONLY. DO NOT USE ON DAMAGED OR BROKEN SKIN. WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE. STOP USE AND ASK A DOCTOR IF RASH OCCURS. KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Inactive Ingredient

Other Ingredients:ALOE BARBADENSIS LEAF JUICE, BEESWAX, BHT, CAPRYLIC/CAPRIC TRIGLYCERIDE, COCOS NUCIFERA (COCONUT) OIL, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, HYDROGENATED VEGETABLE OIL, LANOLIN, MANGIFERA INDICA (MANGO) SEED BUTTER, PERSEA GRATISSIMA (AVOCADO) OIL, RICINUS COMMUNIS (CASTOR) SEED OIL, TOCOPHEROL, TOCOPHERYL ACETATE (VITAMIN E)

* Please review the disclaimer below.