NDC 70630-1902 Bali Body Spf 15 Cacao Tanning Oil

Octinoxate, Octocrylene Cream

NDC Product Code 70630-1902

NDC Code: 70630-1902

Proprietary Name: Bali Body Spf 15 Cacao Tanning Oil 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: Octinoxate, Octocrylene Cream 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

  • 70630 - Bali Body Pty Ltd
    • 70630-1902 - Bali Body Spf 15 Cacao Tanning Oil

NDC 70630-1902-1

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Bali Body Spf 15 Cacao Tanning Oil with NDC 70630-1902 is a a human over the counter drug product labeled by Bali Body Pty Ltd. The generic name of Bali Body Spf 15 Cacao Tanning Oil is octinoxate, octocrylene cream. The product's dosage form is oil and is administered via topical form.

Labeler Name: Bali Body Pty Ltd

Dosage Form: Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.

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.

Bali Body Spf 15 Cacao Tanning Oil 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.

  • OCTOCRYLENE 2.5 mg/100mL
  • OCTINOXATE 2.5 mg/100mL
  • AVOBENZONE 1 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.

  • ALMOND OIL (UNII: 66YXD4DKO9)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • PERSIC OIL (UNII: 5M26W7T072)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • C15-23 ALKANE (UNII: J3N6X3YK96)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

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: Bali Body Pty Ltd
Labeler Code: 70630
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: 06-17-2019 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’.

* Please review the disclaimer below.

Bali Body Spf 15 Cacao Tanning Oil Product Label Images

Bali Body Spf 15 Cacao Tanning Oil 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

Octinoxate 2.5%Octocrylene 2.5%Avobenzone 1%

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Otc - Purpose

A tanning and body oil.Provides SPF 6 protection.

Indications & Usage

Shake well before use. Apply liberaly 15 minutes before sun exposure.Children under 6 months old: Ask a doctor.Re-apply every 2 hours.Use water-resistant sunscreen if swimming or sweating.Store in cool dry place.

Inactive Ingredient

Vitis Vinifera (Grape) seed oilCocos Nucifera Oil (Coconut)Sweet Almond OilVitamin EDicaprylyl CarbonateHydrogenated Soy PolyglyceridesSoybean OilC15-23 AlkaneBHTBenzyl Alcohol ​

Warnings

Skin Cancer/Skin Ageing 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.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.Always wear a hat, protective clothing and sunglasses.

Dosage & Administration

Apply liberally 15 minutes before sun exposure.

* Please review the disclaimer below.

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