NDC 81104-110 Glow Body Mist Spf 50

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 81104-110

NDC 81104-110-01

Package Description: 150 mL in 1 BOTTLE, SPRAY

NDC Product Information

Glow Body Mist Spf 50 with NDC 81104-110 is a a human over the counter drug product labeled by Naked Sundays Pty Ltd. The generic name of Glow Body Mist Spf 50 is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is spray and is administered via topical form.

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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 Body Mist 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.

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.

  • ALCOHOL (UNII: 3K9958V90M)

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 Sundays 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 Body Mist Spf 50 Product Label Images

Glow Body Mist 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

Otc - Active Ingredient



Helps prevent Sunburn If used as directed with other sun Protection measure ( see directions), decrease 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

When Using This Product

Keep out of eyes, Rinse with water to remove

Stop Use And Ask A Doctor

If rash occurs

Keep Out Of Reach Of Children

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


Generously spray to exposed areas holding bottle 10-15 cm away from skin. Ensure even application by spraying at least 7 times per section of body until product is visible, Rub in lightly.Use a water- resistant sunscreen if swimming or sweating.reapply at least every 2 hours.Children under 6 months of age : ask a doctor

Inactive Ingredients

Alcohol, Citrullius Lanatus Seed oil, Kakadu Plum, Tocopheryl Acetate, Fragrance

Other Information

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

Sun Protection Measures

Spending time in the Sun Increases your risk of skin cancer and early skin ageing. 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 10.00 AM - 2.00 PMWea long-sleeved Shirts , pants hats, and sunglasses,



* Please review the disclaimer below.