NDC 75796-004 Body Conditioner

Titanium Dioxide, Zinc Oxide

NDC Product Information

Body Conditioner with NDC 75796-004 is a a human over the counter drug product labeled by Make2give Llc. The generic name of Body Conditioner is titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Make2give Llc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the 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.

Body Conditioner 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.

  • TITANIUM DIOXIDE 40 mg/mL
  • ZINC OXIDE 50 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.

  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • WATERMELON (UNII: 231473QB6R)
  • CARROT (UNII: L56Z1JK48B)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
  • GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • MANGO (UNII: I629I3NR86)
  • POMEGRANATE (UNII: 56687D1Z4D)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CORN (UNII: 0N8672707O)
  • PROPANEDIOL (UNII: 5965N8W85T)

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: Make2give Llc
Labeler Code: 75796
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: 06-01-2020 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.

Body Conditioner Product Label Images

Body Conditioner 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

Titanium Dioxide 4%Zinc Oxide 5%

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 the sun

Warnings

For external use only.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Using And Ask A Doctor

If a rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

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

Directions

• Apply liberally and spread evenly 15 minutes before sun exposure and as needed.


• Reapply at least every 2 hours


• Use a water resistant sunscreen if swimming or sweating





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 of 15 or higher and other sun protection measures including • limit time in the sun, especially from 10 am- 2pm • wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredients

Acrylates Copolymer, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Butyrospermum Parkii (Shea) Butter), C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetyl Alcohol, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Extract, Cocos Nucifera (Coconut) Oil, Decyl Glucoside, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Lecithin, Mangifera lndica (Mango) Butter, Parfum (Natural Fragrance), Punica Granatum (Pomegranate) Extract, Saccharide lsomerate, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol.

Other Information

Protect the product from excessive heat and direct sun.

* Please review the disclaimer below.