NDC 73432-001 Coco Glow Sun Balm

Zinc Oxide

NDC Product Code 73432-001

NDC 73432-001-01

Package Description: 1 JAR in 1 BOX > 47 g in 1 JAR

NDC Product Information

Coco Glow Sun Balm with NDC 73432-001 is a a human over the counter drug product labeled by Osea Intl, Llc. The generic name of Coco Glow Sun Balm is zinc oxide. The product's dosage form is paste and is administered via topical form.

Labeler Name: Osea Intl, Llc

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Coco Glow Sun Balm 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.

  • ZINC OXIDE 8.46 g/47g

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.

  • COCONUT OIL (UNII: Q9L0O73W7L)
  • GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
  • COCO-GLYCERIDES (UNII: ISE9I7DNUG)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CYLINDROTHECA FUSIFORMIS (UNII: F4J2H3D5OU)
  • DIACRONEMA LUTHERI (UNII: 5N7X0S4J0B)
  • RICE BRAN (UNII: R60QEP13IC)
  • ROSEMARY (UNII: IJ67X351P9)
  • SUNFLOWER SEED (UNII: R9N3379M4Z)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: Osea Intl, Llc
Labeler Code: 73432
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: 03-12-2021 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: 12-31-2022 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.

Coco Glow Sun Balm Product Label Images

Coco Glow Sun Balm 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

Dist. by OSEA Intl. LLC Malibu, CA 90265

Active Ingredients

Zinc Oxide 18%

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 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, contact a Poison Control Center right away.

Directions

  • Gently glide enclosed spatula across the Coco Glow Sun Balm SPF 30 Mineral Sunscreen. Place into the palm of hand. Blend with fingertips until balm melts to a smooth texture.Apply liberally 15 minutes before sun exposure and as needed.Reapply at least every 2 hours.Use water-resistant sunscreen if swimming or sweating.Children under 6 months: ask a doctor.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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10AM - 2PM.Wear long-sleeve shirts, pants, hats, and sunglasses.

Other Information

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

COCOS NUCIFERA (Coconut) OILOrganic Ingredient, GLYCERYL DIBEHENATE, COCOGLYCERIDES, TRIBEHENIN, GLYCERYL BEHENATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CYLINDROTHECA FUSIFORMIS EXTRACT, PAVLOVA LUTHERI EXTRACT, ORYZA SATIVA (Rice) BRAN EXTRACT, ROSMARINUS OFFICINALIS (Rosemary) LEAF EXTRACT, HELIANTHUS ANNUUS (Sunflower) SEED EXTRACT, TOCOPHEROL, IRON OXIDES (CI 77492, CI 77491, CI 77499)

* Please review the disclaimer below.