NDC 63354-902 Hawaiian Tropic Lip Balm Sunscreen Spf 25

Avobenzone, Octisalate, Octocrylene

NDC Product Code 63354-902

NDC CODE: 63354-902

Proprietary Name: Hawaiian Tropic Lip Balm Sunscreen Spf 25 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
    • 63354-902 - Hawaiian Tropic Lip Balm Sunscreen Spf 25

NDC 63354-902-61

Package Description: 3.97 g in 1 CYLINDER

NDC Product Information

Hawaiian Tropic Lip Balm Sunscreen Spf 25 with NDC 63354-902 is a a human over the counter drug product labeled by Edgewell Personal Care Brands Llc. The generic name of Hawaiian Tropic Lip Balm Sunscreen Spf 25 is avobenzone, octisalate, octocrylene. The product's dosage form is stick and is administered via topical form.

Labeler Name: Edgewell Personal Care Brands Llc

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

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 Lip Balm Sunscreen Spf 25 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 3 g/100g
  • OCTOCRYLENE 10 g/100g
  • OCTISALATE 5 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.

  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • CERESIN (UNII: Q1LS2UJO3A)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • RICE BRAN (UNII: R60QEP13IC)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

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: 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: 12-15-2020 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’.

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Hawaiian Tropic Lip Balm Sunscreen Spf 25 Product Label Images

Hawaiian Tropic Lip Balm Sunscreen Spf 25 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 3.0%, Octisalate 5.0%, Octocrylene 10.0%

Purpose

Sunscreen

Uses

Helps prevent sunburn

Warnings

For external use only.May stain some fabricsSkin 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.

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

Keep Out Of Reach Of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure • reapply: after 80 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours • reapply after eating or drinking • Children under 6 months: Ask a doctor.

Inactive Ingredient

Caprylic/Capric Triglyceride, Ozokerite, Petrolatum, Ethylhexyl Palmitate, Flavor, Oryza Sativa (RIce) Bran Wax, VP/Eicosene Copolymer, PEG-8, Sodium Saccharin, Tocopheryl Acetate

Other Information

Protect this product from excessive heat and direct sun

Primary Display Panel

TROPICAL flavorSPF25HAWAIIANTropic (R)LIP BALMSunscreen StickReef Friendly*MOISTURIZESFOR 12 HOURS.14 OZ.

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