NDC 70630-0005 Watermelon Tanning Oil Spf6

Octocrylene, Octinoxate, Avobenzone

NDC Product Code 70630-0005

NDC 70630-0005-1

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Watermelon Tanning Oil Spf6 with NDC 70630-0005 is a a human over the counter drug product labeled by Bali Body Pty Ltd. The generic name of Watermelon Tanning Oil Spf6 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.

Watermelon Tanning Oil Spf6 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 25 mg/mL
  • OCTINOXATE 25 mg/mL
  • AVOBENZONE 10 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)
  • WATERMELON (UNII: 231473QB6R)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • C15-23 ALKANE (UNII: J3N6X3YK96)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

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.

Watermelon Tanning Oil Spf6 Product Label Images

Watermelon Tanning Oil Spf6 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 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 a cool dry place.

Warnings / Cautions / Sun Safety:

Spending time in the sun increases your risk of skin cancer or early skin ageing. This product has been shown only to prevent sunburn, not skin cancer or early skin ageing.

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.

Use:

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

Active Ingredients:

Octocrylene 2.5%,


Octinoxate 2.5%,


Avobenzone 1%.

Purpose:

Sunsreen

Inactive Ingredients:

Vitis Vinifera (Grape) Seed Oil, Prunu Amygdalus Dulcis (Sweet Almond) Oil, Cocos Nucifera (Coconut) Oil,Dicaprylyl Carbonate, Hydrogenated Soy Polyglyceride, Citrullus Vulgais (Watermelon) Seed Oil, Octocrylene, Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Glycine Soja (Soybean) Oil, Tocopherol, Natural Watermelon Fragrance (Naturally Dervied)C15-23, BHT.

* Please review the disclaimer below.