NDC 61477-222 Aloe Up Coco-mango Spf-10

Avobenzone, Octisalate, Octocrylene

NDC Product Code 61477-222

NDC Code: 61477-222

Proprietary Name: Aloe Up Coco-mango Spf-10 Additional informationCallout TooltipWhat 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, Octisalate, Octocrylene Additional informationCallout TooltipWhat 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.


Code Structure
  • 61477 - Aloe Care International, Llc
    • 61477-222 - Aloe Up Coco-mango

NDC 61477-222-14

Package Description: 118 mL in 1 TUBE

NDC Product Information

Aloe Up Coco-mango Spf-10 with NDC 61477-222 is a a human over the counter drug product labeled by Aloe Care International, Llc. The generic name of Aloe Up Coco-mango Spf-10 is avobenzone, octisalate, octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Aloe Care International, 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 Additional informationCallout TooltipWhat 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 Coco-mango Spf-10 Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AVOBENZONE 1 g/100mL
  • OCTISALATE 3.75 g/100mL
  • OCTOCRYLENE 3 g/100mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • BUTYLPHTHALIDE (UNII: 822Q956KGM)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
  • ISOPROPYLPHTHALIMIDE (UNII: 1J1MM83329)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • 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)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-18-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Aloe Up Coco-mango Spf-10 Product Label Images

Aloe Up Coco-mango Spf-10 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 (1.0%)OCTISALATE (3.75%)OCTOCRYLENE (3.0%)

Purpose

SUNSCREEN

Uses

  • Helps prevent sunburn

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 • children under 6 months: Ask a doctor

Otc - Keep Out Of Reach Of Children

KEEP OUT OF REACH OF CHILDREN. If product is 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 prevent sunburn, not skin cancer or early skin aging. For external use onlyDo not use on damaged or broken skinWhen using this product keep out of eyes. Rinse with water to remove.Stop use and ask a doctor if rash occurs

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice, Aluminum Starch Octenylsuccinate, Butylphthalimide, C12-15 Alkyl Benzoate,Camellia Sinensis Leaf Extract, Carbomer, Fragrance, Iodopropynyl Butylcarbamate, Isodecyl Neopentanoate, Isopropylphthalimide, PEG-8, Phenoxyethanol, Polysorbate 20, Polyethylene, Propanediol, Sorbitol, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine,Trisodium Ethylenediamine Disuccinate, Water

Other Information

  • Protect this container from excessive heat and direct sun.

* Please review the disclaimer below.

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