NDC 63354-601 Hawaiian Tropic

Avobenzone Homosalate Octisalate Octocrylene

NDC Product Code 63354-601

NDC 63354-601-37

Package Description: 319 g in 1 BOTTLE

NDC 63354-601-56

Package Description: 236 g in 1 BOTTLE

NDC Product Information

Hawaiian Tropic with NDC 63354-601 is a a human over the counter drug product labeled by Edgewell Personal Care Brands Llc. The generic name of Hawaiian Tropic is avobenzone homosalate octisalate octocrylene. The product's dosage form is lotion and is administered via topical form.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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 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.


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.

  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MICA (UNII: V8A1AW0880)
  • 2-ETHYLHEXYL BENZOATE (UNII: R63ZWW1A13)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • COCO GLUCOSIDE (UNII: ICS790225B)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)
  • PROPYLENE GLYCOL DIBENZOATE (UNII: EQY32Z1AN4)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • JOJOBA BUTTER (UNII: XIA46H803R)
  • MANGO (UNII: I629I3NR86)
  • PAPAYA (UNII: KU94FIY6JB)
  • PSIDIUM GUAJAVA WHOLE (UNII: 4J570BB45U)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WATER (UNII: 059QF0KO0R)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • PASSIFLORA INCARNATA FRUIT (UNII: SF206I8G4P)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • 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.

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: 01-04-2016 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hawaiian Tropic Product Label Images

Hawaiian Tropic 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 3.0%,Octisalate 4.5%, Octocrylene 3.0%

Purpose

Sunscreen

Uses

Helps prevent sunburnIf 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 Use And Ask A Doctor

If rash ocurs

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 2 hours •Children under 6 months: Ask a doctorSun 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 value 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.

Inactive Ingredients

Water, Cetearyl Alcohol, Phenoxyethanol,VP/Eicosene Copolymer, Mica, Diisopropyl Adipate, Ethylhexyl Benzoate, Glycerin, Fragrance, Neopentyl Glycol Diheptanoate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Methylparaben, Coco-Glucoside, Dimethicone, Polymethylsilsesquioxane,Propylparaben, Sodium Hydroxide, Ceteth-10 Phosphate, Dicetyl Phosphate, Propylene Glycol Dibenzoate, Disodium EDTA, Paraffin, Xanthan Gum, Butyrospermum Parkii (Shea) Butter, Jojoba Alcohol,Potassium Jojobate, Simmondsia Chinensis (Jojoba) Butter, Mangifera Indica (Mango) Seed Butter, Propanediol, Tocopheryl Acetate, Carica Papaya (Papaya) Fruit Extract, Colocasia Antiquorum Root Extract, Mangifera Indica (Mango) Fruit Extract, Passiflora Incarnata Fruit Extract, Plumeria Acutifolia Flower Extract, Psidium Guajava Fruit Extract, Panthenol, Aloe Barbadensis Leaf Juice, Sodium Ascorbyl Phosphate, Titanium Dioxide.

Other Information

Protect this product from excessive heat and direct sun

Pdp

HAWAIIANTropicSheer TouchLotion SunscreenULTRA RADIANCEPROTECTS, SOFTENSLEAVES SKIN RADIANT15BROAD SPECTRUMSPF15UVA & UVB protectionnon-greasyoil freewater resistant(80 minutes)

* Please review the disclaimer below.