NDC 73563-011 Sunscreen With Aloe Vera Spf 30

Octinoxate, Octisalate, And Oxybenzone

NDC Product Code 73563-011

NDC 73563-011-01

Package Description: 3785 mL in 1 JUG

NDC 73563-011-18

Package Description: 532 mL in 1 BOTTLE, PLASTIC

NDC Product Information

Sunscreen With Aloe Vera Spf 30 with NDC 73563-011 is a a human over the counter drug product labeled by Body One Products, Inc.. The generic name of Sunscreen With Aloe Vera Spf 30 is octinoxate, octisalate, and oxybenzone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Body One Products, Inc.

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 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.

Sunscreen With Aloe Vera Spf 30 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.

  • OCTINOXATE 75 mg/mL
  • OCTISALATE 50 mg/mL
  • OXYBENZONE 60 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.

  • WATER (UNII: 059QF0KO0R)
  • ALLANTOIN (UNII: 344S277G0Z)
  • CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
  • GULOSE, L- (UNII: J96E9Q45N7)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • HEXAMETHYLDISILOXANE (UNII: D7M4659BPU)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)

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: Body One Products, Inc.
Labeler Code: 73563
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 02-01-2020 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.

Sunscreen With Aloe Vera Spf 30 Product Label Images

Sunscreen With Aloe Vera Spf 30 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

Skin Cancer/Skin Aging AlertSpending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only

Otc - Purpose

Active IngredientsPurposeOctinoxate 7.5%SunscreenOctisalate 5.0%SunscreenOxybenzone 6.0%Sunscreen

Uses

  • *Helps prevent sunburn

Otc - Do Not Use

Do Not Use on damaged skin 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 swallowed , get medical help or contact a Poison Control Center right away.

Directions

  • *Apply liberally 15 minutes before sun exposure.*Use a water resistant sunscreen if swimming or sweating.*Reapply at least every 2 hours.*Children under 6 months: ask a Doctor.

Other Information

Protect this product container from excessive heat and direct sun.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Brassica Campestris/Aleurites Fordi Oil Copolymer, Butyl Paraben, Carbomer, Dimethicone, Ethylparaben, Fragrance,Glyceryl Stearate SE, Isobutylparaben, Lanolin Alcohol, Methylparaben,Mineral Oil, Phenoxyethanol, Propylparaben, Stearic Acid , Water.

* Please review the disclaimer below.