NDC 68975-012 Love Sun Body Spf 50 Fragrance Free

Zinc Oxide, Titanium Dioxide

NDC Product Code 68975-012

NDC Code: 68975-012

Proprietary Name: Love Sun Body Spf 50 Fragrance Free Additional informationCallout TooltipWhat 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: Zinc Oxide, Titanium Dioxide Additional informationCallout TooltipWhat 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.


Code Structure
  • 68975 - Emilia Resources, Llc
    • 68975-012 - Love Sun Body Spf 50 Fragrance Free

NDC 68975-012-01

Package Description: 100 mL in 1 BOTTLE

NDC 68975-012-02

Package Description: 200 mL in 1 BOTTLE

NDC Product Information

Love Sun Body Spf 50 Fragrance Free with NDC 68975-012 is a a human over the counter drug product labeled by Emilia Resources, Llc. The generic name of Love Sun Body Spf 50 Fragrance Free is zinc oxide, titanium dioxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Emilia Resources, Llc

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 Additional informationCallout TooltipWhat 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.


Love Sun Body Spf 50 Fragrance Free Active Ingredient(s)

Additional informationCallout TooltipWhat 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 210 mg/mL
  • TITANIUM DIOXIDE 72 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • ALMOND OIL (UNII: 66YXD4DKO9)
  • WATER (UNII: 059QF0KO0R)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • TOCOPHEROL (UNII: R0ZB2556P8)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Emilia Resources, Llc
Labeler Code: 68975
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Love Sun Body Spf 50 Fragrance Free Product Label Images

Love Sun Body Spf 50 Fragrance Free 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

Zinc Oxide (Non-nano) 21%Titanium Dioxide (Non-nano) 7.2%

Purpose

Sunscreen

Uses

  • Helps Prevent SunburnIf 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

Do Not Use On

Damaged or broken skin

Stop Use And Ask A Doctor If

Rash occurs

When Using This Product

Keep out of eyes, rinse with water to remove

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Center right away.

Directions

  • For full protection, apply liberally to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect
  • ReapplyAfter 80 minutes of swimming or sweating After towel dryingAt least every 2 hours
  • Sun Protection MeasuresSpending time in the sun increases your risk of skin cancer an early aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures includingLimit time in the sun, especially from 10am to 2pm.Wear long-sleeved shirts, pants, hats and sunglasses.

Other Information

  • Protect this product from excessive heat and direct sun.Store at temperatures below 90°FMay stain some fabrics.Shake bottle if separation occurs or after storing 60 days.

Inactive Ingredients

Almond Oil, Aqua/Water, Benzoic Acid, Caprylic/Capric Triglyceride (Coconut Oil), Cetyl Alcohol, Glycerin, Glyceryl Stearate SE, Polyhydroxystearic Acid, Silica, Sorbitan Laurate, Stearic Aicd, Sunflower Oil and Tocopherol

* Please review the disclaimer below.

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