NDC 61477-213 Aloe Up Sunscreen Spf 50
Avobenzone, Homosalate, Octisalate, Octocrylene, Octinoxate Lotion Topical

Product Information

Aloe Up Sunscreen Spf 50 is a human over the counter drug product labeled by Aloe Care International, Llc. The generic name of Aloe Up Sunscreen Spf 50 is avobenzone, homosalate, octisalate, octocrylene, octinoxate. The product's dosage form is lotion and is administered via topical form.

Product Code61477-213
Proprietary Name 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.
Aloe Up Sunscreen Spf 50
Non-Proprietary Name 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.
Avobenzone, Homosalate, Octisalate, Octocrylene, Octinoxate
Product Type 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.
Human Otc Drug
Dosage FormLotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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.
Aloe Care International, Llc
Labeler Code61477
FDA Application Number 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.
part352
Marketing Category 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.
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
02-24-2014
Listing Expiration Date 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.
12-31-2023
Exclude Flag 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".
N
NDC Code Structure

What are the uses for Aloe Up Sunscreen Spf 50?


Product Packages

NDC 61477-213-14

Package Description: 118 mL in 1 TUBE

Product Details

What are Aloe Up Sunscreen Spf 50 Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

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.
  • CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
  • CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
  • CARBOMER 934 (UNII: Z135WT9208)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • SORBITOL (UNII: 506T60A25R)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • WATER (UNII: 059QF0KO0R)

* Please review the disclaimer below.

Aloe Up Sunscreen Spf 50 Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Otc - Active Ingredient



ACTIVE INGREDIENTS:

AVOBENZONE (3%)

HOMOSALATE (5%)

OCTINOXATE (6%)

OCTISALATE (5%)

OCTOCRYLENE (10%)


Otc - Purpose



PURPOSE:

SUNSCREEN


Indications & Usage



INDICATIONS:

HELPS PREVENT SUNBURN.


Dosage & Administration



DIRECTIONS:

APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE.

REAPPLY: AFTER 40 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL DRYING; AT LEAST EVERY 2 HOURS.


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 PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.


Inactive Ingredient



Other Ingredients:

ACRYLATES/C10-30 ALKYL ACRYLATES CROSSPOLYMER, ALLANTOIN, ALOE BARBADENSIS LEAF JUICE, ALUMINUM STARCH OCTENYLSUCCINATE, BUTYLOCTYL SALICYLATE, C12-15 ALKYL BENZOATE, CAMELLIA SINENSIS LEAF EXTRACT, CARBOMER, IODOPROPYNYL BUTYLCARBAMATE, ISODECYL NEOPENTANOATE, METHYLISOTHIAZOLINONE, PHENOXYETHANOL, POLYETHYLENE, POLYSORBATE 20, PROPANEDIOL, SORBITOL, THEOBROMA CACAO (COCOA) SEED BUTTER, TOCOPHERYL ACETATE, TRIETHANOLAMINE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, WATER


Package Label.Principal Display Panel




* Please review the disclaimer below.