NDC 81104-111 Glow Go Lip Oil Spf50

Avobenzone 30mg/g, Homosalate 100mg/g, Octocrylene 100mg/g, Octisalate 50mg/g, (sunscreens)

NDC Product Code 81104-111

NDC CODE: 81104-111

Proprietary Name: Glow Go Lip Oil Spf50 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 30mg/g, Homosalate 100mg/g, Octocrylene 100mg/g, Octisalate 50mg/g, (sunscreens) 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

  • 81104 - Naked Sunday Pty Ltd

NDC 81104-111-02

Package Description: 4.5 mL in 1 BOTTLE

NDC Product Information

Glow Go Lip Oil Spf50 with NDC 81104-111 is a a human over the counter drug product labeled by Naked Sunday Pty Ltd. The generic name of Glow Go Lip Oil Spf50 is avobenzone 30mg/g, homosalate 100mg/g, octocrylene 100mg/g, octisalate 50mg/g, (sunscreens). The product's dosage form is oil and is administered via topical form.

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.

Glow Go Lip Oil Spf50 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.

  • MICA (UNII: V8A1AW0880)

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: Naked Sunday Pty Ltd
Labeler Code: 81104
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: 09-01-2021 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".

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Glow Go Lip Oil Spf50 Product Label Images

Glow Go Lip Oil Spf50 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





- Helps prevents sunburn- If used as directed with other sun protection measures ( see directions) decreases the risk of skin cancer and early skin ageing caused by the sun.


FOR EXTERNAL USE ONLY- Do not use on damaged or broken skin.

Otc - When Using

Keep out of eyes, Rinse with water to remove

Stop Use & Ask Doctor

If rash occurs

Otc - Keep Out Of Reach Of Children

If product is swallowed , get medical help or contact a poison control center right away


- Apply 20 minutes before sun exposure - Use a water resistant sunscreen if swimming or sweating- Re-apply frequently especially after swimming excercising or towel drying- Re-apply at least every 2 hours - Children under 6 months of age- 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 inclusing:- limit time in the sun, especially from 10:00 AM- 02:00 PM- Wear long- Sleeved shirts , pants, Hats and sunglasses


Candelilla wax, Ethylhexylglycerin, Flavour, Isopropyl myristate, MICA, Octyldodecanol, Phenoxyethanol, Polybutene, Raspberry oil, Tomato extract, Watermelon oil

Other Safety Information

Protect the product in this container from excessive heat & direct sun



* Please review the disclaimer below.