NDC 76354-922 Camo Cc Cream Spf30 Tan 450 N

Octinoxate, Titanium Dioxide, Zinc Oxide

NDC Product Code 76354-922

NDC 76354-922-01

Package Description: 1 BOTTLE in 1 BOX > 30 g in 1 BOTTLE

NDC Product Information

Camo Cc Cream Spf30 Tan 450 N with NDC 76354-922 is a a human over the counter drug product labeled by J. A. Cosmetics U.s. Inc. The generic name of Camo Cc Cream Spf30 Tan 450 N is octinoxate, titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: J. A. Cosmetics U.s. Inc

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.

Camo Cc Cream Spf30 Tan 450 N 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/g
  • TITANIUM DIOXIDE 44.5 mg/g
  • ZINC OXIDE 137.2 mg/g

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)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • CANOLA OIL (UNII: 331KBJ17RK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CARROT SEED OIL (UNII: 595AO13F11)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • CARROT (UNII: L56Z1JK48B)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • BETA CAROTENE (UNII: 01YAE03M7J)
  • PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
  • PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: J. A. Cosmetics U.s. Inc
Labeler Code: 76354
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: 09-01-2020 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.

Camo Cc Cream Spf30 Tan 450 N Product Label Images

Camo Cc Cream Spf30 Tan 450 N 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

Octinoxate 7.5%


Titanium Dioxide 4.45%


Zinc Oxide 13.72%

Purpose

Sunscreen

Use

  • Helps prevent sunburnIf used as directed with other sun protecion 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 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 sun screen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in 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 the product in this container from excessive heat and direct sun.

Inactive Ingredients

Water (Aqua), Dimethicone, Cylopentasiloxane, Butylene Glycol, Phenyl Trimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol Dicaprylate/Dicaprate, Butyloctyl Salicylate, POlyglyceryl-4 Isostearate, Methyl Methacrylate Crosspolymer, Cyclohexasiloxane, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Hexyl Laurate, Magnesium Sulfate, Phenoxyethanol, Triethoxycaprylylylsilane, Disteardimonium Hectorite, Hydrated Silica, Aluminium Hydroxide, Propylene Carbonate, Dimethicone/Methicone Copolymer, Caprylyl Glycol, Ethylhexylglycerin, Disodium Edta, Tocopheryl Acetate, Sodium Hyaluronate, Niacinamide, Panthenol, Ascorbyl Palmitate, Soluble Collagen, Canola Oil, Glycerin, Daucu Carota Sativa (Carrot) See Oil, Carbomer, Daucus Carota Sativa (Carrot) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Beta-Carotene, Poly-sorbate 20, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, 1,2-Hexanediol


May Contain: Titanium Dioxide (CI 77891), Yellow Iron Oxide(CI 77492), Red Iron Oxide (CI77491), Black Iron Oxide (CI 77499)

* Please review the disclaimer below.