NDC 70630-0010 Peach Tanning Oil Spf15

Octocrylene, Octinoxate, Avobenzone

NDC Product Code 70630-0010

NDC 70630-0010-1

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Peach Tanning Oil Spf15 with NDC 70630-0010 is a a human over the counter drug product labeled by Bali Body Pty Ltd. The generic name of Peach Tanning Oil Spf15 is octocrylene, octinoxate, avobenzone. 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.

Peach Tanning Oil Spf15 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 50 mg/mL
  • OCTINOXATE 50 mg/mL
  • AVOBENZONE 20 mg/mL

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.

  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • PERSIC OIL (UNII: 5M26W7T072)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • C15-23 ALKANE (UNII: J3N6X3YK96)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)

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: 01-01-2021 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 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.

Peach Tanning Oil Spf15 Product Label Images

Peach Tanning Oil Spf15 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

Directions:

Shake well before use. Apply liberally 20 minutes before sun exposure. Re-apply your BB every 1-2 hours, after swimming or exercise..

When Using This Product

Keep out of eyes. If contact occurs rinse with water to remove.

Stop Use And Seek Medical Advise

If rash occurs. Wear sun-smart options such as hat and sunglasses.

Do Not Use

On damaged or broken skin. Can aid in the prevention of premature skin ageing.

Use:

Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

Active Ingredients:

Octocrylene 5%,


Octinoxate 5%,


Avobenzone 2%.

Purpose:

Sunsreen

Inactive Ingredients:

Vitis Vinifera (Grape) Seed Oil, Prunus Amygdalus (Sweet Almond) Oil, Cocos Nucifera (Coconut) Oil, Octocrylene, Ethylhexyl Methoxycinnamate, Dicaprylyl Carbonate, Hydrogenated Soy Polyglyceride, Butyl Methoxydibenzoylmethane, Prunus Persica (Peach)Kernel Oil, Glycine Soja (Soybean) Oil, Tocopherol, C15-23 Alkane, BHT, Fragrance (Parfum), Benzyl Alcohol*

* Please review the disclaimer below.