NDC 69522-2618 Big Cloud Defend Daily Face Moisturizer Broad Spectrum Spf30

Avobenzone, Homosalate And Octocrylene Lotion

NDC Product Code 69522-2618

NDC CODE: 69522-2618

Proprietary Name: Big Cloud Defend Daily Face Moisturizer Broad Spectrum Spf30 What 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: Avobenzone, Homosalate And Octocrylene Lotion What 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.

NDC Code Structure

  • 69522 - Dollar Shave Club, Inc.

NDC 69522-2618-1

Package Description: 1 mg in 1 BOTTLE, PUMP

NDC 69522-2618-2

Package Description: 1 mg in 1 TUBE

NDC Product Information

Big Cloud Defend Daily Face Moisturizer Broad Spectrum Spf30 with NDC 69522-2618 is a a human over the counter drug product labeled by Dollar Shave Club, Inc.. The generic name of Big Cloud Defend Daily Face Moisturizer Broad Spectrum Spf30 is avobenzone, homosalate and octocrylene lotion. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Dollar Shave Club, 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.

Big Cloud Defend Daily Face Moisturizer Broad Spectrum Spf30 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.

  • HOMOSALATE 7 mg/100mg
  • OCTOCRYLENE 4.5 mg/100mg
  • AVOBENZONE 2.5 mg/100mg

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.

  • MINT (UNII: FV98Z8GITP)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ANOGEISSUS LEIOCARPUS BARK (UNII: U5TP1X38RH)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • KAKADU PLUM (UNII: 0ZQ1D2FDLI)
  • ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
  • COUMARIN (UNII: A4VZ22K1WT)
  • LINALOOL, (+)- (UNII: F4VNO44C09)
  • HEXASODIUM PHYTATE (UNII: ZBX50UG81V)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • FIG (UNII: TGD87RII2U)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
  • CETEARETH-6 OLIVATE (UNII: 8834VWF9MO)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)

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: Dollar Shave Club, Inc.
Labeler Code: 69522
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: 05-01-2020 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’.

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Big Cloud Defend Daily Face Moisturizer Broad Spectrum Spf30 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

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

Directions

• Apply liberally 15 minutes before sun exposure. 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 value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m. - 2 p.m., • wear long-sleeved shirts, pants, hats, and sunglasses. • Children under 6 months of age: Ask a doctor.

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Neopentyl Glycol Diheptanoate, Diisopropyl Adipate, Ceteareth-6 Olivate, Glycerin, Butyloctyl Salicylate, Cetearyl Olivate, Polymethylsilsesquioxane, Butyrospermum Parkii (SHea) Butter, Aloe Barbadensis Leaf Juice, Terminalia Ferdinandiana Fruit Extract, Anogeissus Leiocarpa Bark Extract, Sorbitan Olivate, Caprylyl Glycol, Silica, Acrylates/C10-30 Alkyl acrylate Crosspolymer, Caprylhydroxamic Acid, Sodium Phytate, Xanthan Gum, Sodium Hydroxide, Citric Acid, Propanediol, Ethylhexylglycerin, Phenoxyethanol, Alpha-Isomethyl Ionone, Coumarin, Hydroxycitronellal, Linalool, Fragrance.

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