NDC 52854-255 Native Tan Spf 50

Octocrylene, Octisalate, Oxybenzone, And Avobenzone

NDC Product Code 52854-255

NDC 52854-255-01

Package Description: 120 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Native Tan Spf 50 with NDC 52854-255 is a a human over the counter drug product labeled by Tropical Seas, Inc.. The generic name of Native Tan Spf 50 is octocrylene, octisalate, oxybenzone, and avobenzone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Tropical Seas, Inc.

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.

Native Tan Spf 50 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 5 g/100mL
  • OCTISALATE 5 g/100mL
  • OXYBENZONE 4 g/100mL
  • AVOBENZONE 2 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENETHYL BENZOATE (UNII: 0C143929GK)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • CETYL DIMETHICONE 150 (UNII: 5L694Y0T22)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • TRICONTANYL POVIDONE (UNII: N0SS3Q238D)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: Tropical Seas, Inc.
Labeler Code: 52854
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: 07-01-2012 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.

Native Tan Spf 50 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

Other

Drug Facts

Active Ingredients

Octocrylene 5.0%
Octisalate 5.0%
Oxybenzone 4.0%
Avobenzone 2.0%

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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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 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

Deionized water, phenethyl benzoate, octyl dodecyl citrate crosspolymer, stearic acid (vegetable derived), glyceryl stearate se (vegetable derived), cetyl dimethicone, aloe barbadensis leaf extract, glycerin (coconut derived), sodium hydroxide, emulsifying wax (vegetable derived), tricontanyl-pvp, polyethylene, acrylates/c10-30 alkyl acrylates cross-polymer, cetyl alcohol (vegetable derived), methylparaben, diazolidinyl urea and propylparaben.

Other Information

  • Protect this product from excessive heat and direct sun

* Please review the disclaimer below.