NDC 63354-318 Hawaiian Tropic Island Tanning Broad Spectrum Spf 15

Avobenzone, Octisalate, Octocrylene

NDC Product Code 63354-318

NDC CODE: 63354-318

Proprietary Name: Hawaiian Tropic Island Tanning Broad Spectrum Spf 15 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: Avobenzone, Octisalate, Octocrylene 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

  • 63354 - Edgewell Personal Care Brands Llc
    • 63354-318 - Hawaiian Tropic Island Tanning Broad Spectrum Spf 15

NDC 63354-318-16

Package Description: 227 g in 1 BOTTLE, PUMP

NDC Product Information

Hawaiian Tropic Island Tanning Broad Spectrum Spf 15 with NDC 63354-318 is a a human over the counter drug product labeled by Edgewell Personal Care Brands Llc. The generic name of Hawaiian Tropic Island Tanning Broad Spectrum Spf 15 is avobenzone, octisalate, octocrylene. The product's dosage form is oil and is administered via topical form.

Labeler Name: Edgewell Personal Care Brands Llc

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.

Hawaiian Tropic Island Tanning Broad Spectrum Spf 15 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.

  • AVOBENZONE 2 g/100g
  • OCTISALATE 2.5 g/100g
  • OCTOCRYLENE 3 g/100g

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.

  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
  • TRIS(TRIMETHYLSILOXY)PHENYLSILANE (UNII: S3QI0ZXT5X)
  • TARTARIC ACID (UNII: W4888I119H)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
  • MANGO (UNII: I629I3NR86)
  • .BETA.-CAROTENE (UNII: 01YAE03M7J)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CORN OIL (UNII: 8470G57WFM)
  • HISTIDINE (UNII: 4QD397987E)
  • CARROT (UNII: L56Z1JK48B)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • ARGININE (UNII: 94ZLA3W45F)
  • PAPAYA (UNII: KU94FIY6JB)
  • GUAVA (UNII: 74O70D6VG0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • D&C RED NO. 17 (UNII: ND733RX3JN)
  • D&C YELLOW NO. 11 (UNII: 44F3HYL954)

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.
  • 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: Edgewell Personal Care Brands Llc
Labeler Code: 63354
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: 11-12-2019 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.

Hawaiian Tropic Island Tanning Broad Spectrum Spf 15 Product Label Images

Hawaiian Tropic Island Tanning Broad Spectrum Spf 15 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 2.0%, Octisalate 2.5%, Octocrylene 3.0%

Purpose

Sunscreen

Uses

• helps prevent sunburn • if used as directed with other sun protection measures (see
Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 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.

May Stain

Some fabrics.

Directions

• apply liberally 15 minutes before sun exposure • reapply: • after 80 minutes of swimming or sweating • immediately after towel drying • at least every two hours•
Sun Protection Measures. Spending time in the sun with a broad spectrum SPF of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m. • wear long-sleeve shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

Inactive Ingredients

Ethylhexyl Palmitate, Mineral Oil, Isopropyl Myristate, Silica, Fragrance, Cocos Nucifera (Coconut) Oil, Polybutene, Theobroma Cacao (Cocoa) Seed Butter, Glycine Soja (Soybean) Oil, Zea Mays (Corn) Oil, Arginine, Histidine, Phenyl Trimethicone, Tartaric Acid, Daucus Carota Sativa (Carrot) Root Extract, Tocopheryl Acetate, Mangifera Indica (Mango) Fruit Extract, Carica Papaya (Papaya) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Beta-Carotene, Aloe Barbadensis Leaf Extract, Red 17, Yellow 11

Other Information

• protect this product from excessive heat and direct sun

* Please review the disclaimer below.