NDC 63354-311 Hawaiian Tropic Silk Hydration Broad Spectrum Spf 15

Avobenzone, Homosalate, Octocrylene

NDC Product Code 63354-311

NDC CODE: 63354-311

Proprietary Name: Hawaiian Tropic Silk Hydration 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, Homosalate, 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
    • 63354-311 - Hawaiian Tropic Silk Hydration Broad Spectrum Spf 15

NDC 63354-311-13

Package Description: 148 g in 1 BOTTLE

NDC Product Information

Hawaiian Tropic Silk Hydration Broad Spectrum Spf 15 with NDC 63354-311 is a a human over the counter drug product labeled by Edgewell Personal Care Brands Llc. The generic name of Hawaiian Tropic Silk Hydration Broad Spectrum Spf 15 is avobenzone, homosalate, 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 Silk Hydration 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.

  • OCTOCRYLENE 3.5 g/100g
  • AVOBENZONE 1.5 g/100g
  • HOMOSALATE 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.

  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • PLUMERIA RUBRA FLOWER (UNII: 8P7XXY759H)
  • ISODODECANE (UNII: A8289P68Y2)
  • ALCOHOL (UNII: 3K9958V90M)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • WATER (UNII: 059QF0KO0R)
  • PAPAYA (UNII: KU94FIY6JB)
  • PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
  • MANGO (UNII: I629I3NR86)
  • GUAVA (UNII: 74O70D6VG0)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

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: 09-21-2020 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’.

* Please review the disclaimer below.

Hawaiian Tropic Silk Hydration Broad Spectrum Spf 15 Product Label Images

Hawaiian Tropic Silk Hydration 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 1.5%, Homosalate 5.0%, Octocrylene 3.5%

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.May stain some fabrics.

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 •
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen 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-sleeved shirts, pants, hats, and sunglasses • children under 6 months: Ask a doctor

Inactive Ingedients

Alcohol Denat., Isododecane, Diisopropyl Adipate, Mineral Oil, Phenylisopropyl Dimethicone, Polyglyceryl-3 Stearate/Isostearate/Dimer Dilinoleate Crosspolymer, Lauryl PEG-8 Dimethicone, Caprylyl Glycol, Methyl Dihydroabietate, Fragrance, Tocopheryl Acetate, Ascorbyl Palmitate, Argania Spinosa Kernel Oil, Cocos Nucifera (Coconut) Oil, Vitis Vinifera (Grape) Seed Oil, Olea Europaea (Olive) Fruit Oil, Water, Panthenol, Carica Papaya (Papaya) Fruit Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Aloe Barbadensis Leaf Extract

Other Information

Protect this product from excessive heat and direct sun

Primary Display Panel

HAWAIIANTropic (R)SilkHYDRATION (R)Dry Oil SunscreenWEIGHTLESS OIL15BROAD SPECTRUM SPF 15 UVA/UVBCoconut & Argan OilNon-greasyReef Friendly*5 FL. OZ. (148 mL)

* Please review the disclaimer below.