NDC 70630-0015 Moisturising Sunscreen Spf15

Octocrylene, Octinoxate, Avobenzone, Oxybenzone

NDC Product Code 70630-0015

NDC 70630-0015-1

Package Description: 100 mL in 1 BOTTLE

NDC Product Information

Moisturising Sunscreen Spf15 with NDC 70630-0015 is a a human over the counter drug product labeled by Bali Body Pty Ltd. The generic name of Moisturising Sunscreen Spf15 is octocrylene, octinoxate, avobenzone, oxybenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bali Body Pty Ltd

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.

Moisturising Sunscreen Spf15 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.

  • OCTOCRYLENE 60 mg/mL
  • OCTINOXATE 49 mg/mL
  • AVOBENZONE 30 mg/mL
  • OXYBENZONE 30 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)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • ALMOND OIL (UNII: 66YXD4DKO9)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • JOJOBA OIL (UNII: 724GKU717M)
  • ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
  • GRAPEFRUIT OIL (UNII: YR377U58W9)
  • SOYBEAN OIL (UNII: 241ATL177A)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)

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: Bali Body Pty Ltd
Labeler Code: 70630
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: 01-01-2021 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: 12-31-2021 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.

Moisturising Sunscreen Spf15 Product Label Images

Moisturising Sunscreen Spf15 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

Directions:

Shake well before use. Apply liberally 15 minutes before sun exposure. Children under 6 months old: ask a doctor. Re-apply every 2 hours. Use water-reistant sunscreen if swimming or sweating. Store in a cool dry place.

When Using This Product

Keep out of eyes. rinse with water to remove.

Stop Use And A Doctor

If rash occurs.

Do Not Use

On damaged or broken skin. Wear sun-smart options such as hat and sunglasses.

Use:

Helps prevent sunburn, If used with other sun protection measures decreases the risk of skin cancer.

Active Ingredients:

Octocrylene 6%


Octinoxate 4.9%


Avobenzone 3%


Oxybenzone 3%

Purpose:

Sunsreen

Inactive Ingredients:

Water (Aqua), Dicaprylyl Carbonate, Ethylhexyl Stearate, Glyceryl Stearate, Potassium Cetyl Phosphate, Vitis Vinifera (Grape) Seed Oil, Glycerin, Cetearyl Olivate, Cetearyl Alcohol, Aloe Barbadenis Leaf Juice Powder, Prunus Amygdalus Dulci (Sweet Almond) Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Simmondsia Chinesis (Jojoba) Seed Oil, Rosa Canina Fruit Oil, Citrus Paradisi (Grapefruit) Peel Oil, Glycine Soja (Soybean) Oil, Sorbitan Olivate, Tocopherol, BHT, Sodium Citrate, Citric Acid, Fragrance (Parfum), Hexyl Cinnamal*, Phenoxyethanol, Ethyylhexylglycerin, Benzyl Alcohol.

* Please review the disclaimer below.