NDC 65435-0100 Safe Sea Spf 50

Homosalate, Octocrylene, Octisalate, Avobenzone

NDC Product Code 65435-0100

NDC 65435-0100-1

Package Description: 118 mL in 1 BOTTLE

NDC Product Information

Safe Sea Spf 50 with NDC 65435-0100 is a a human over the counter drug product labeled by Nidaria Technology Ltd. The generic name of Safe Sea Spf 50 is homosalate, octocrylene, octisalate, avobenzone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Nidaria Technology Ltd

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.

Safe Sea 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 100 mg/mL
  • HOMOSALATE 100 mg/mL
  • OCTISALATE 50 mg/mL
  • AVOBENZONE 30 mg/mL

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)
  • DIBUTYL ADIPATE (UNII: F4K100DXP3)
  • POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
  • STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
  • CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • LANTHANUM CHLORIDE (UNII: 04M8624OXV)
  • MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • SORBIC ACID (UNII: X045WJ989B)
  • PHAEODACTYLUM TRICORNUTUM (UNII: Y5W63E7HLV)
  • SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
  • POLYSULFATED GLYCOSAMINOGLYCAN (UNII: 268AW7000T)

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: Nidaria Technology Ltd
Labeler Code: 65435
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: 02-27-2020 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.

Safe Sea Spf 50 Product Label Images

Safe Sea 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

Indications & Usage

Uses: ■ Helps prevent sunburn ■ If used as directed with other sun protection measures (see directions), decreases the risk of skin cancerand early skin aging caused by the sun.

Warnings

Warning: ■ For external use only ■ Do not use on damaged or broken skin ■ When using this product keep out of eyes. Rinse with water toremove ■ 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.

Other Safety Information

Other Information: ■ Give particular attention to coverage of arms and legs. ■ In water infested by Sea Lice, Safe Sea should also be appliedunder the bathing suit.■ Jellyfish can be dangerous. This product should not be considered a recommendation to go into jellyfish infested water,nor is it a guarantee against stings.■ In case of sting do not use Safe Sea as a treatment - seek medical attention.*Tested against Sea nettle(Chrysaora), Atlantic Box jellyfish (Chiropsalmus) & Rhopilema. Data on file. ■ Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.