NDC 46783-275 Micro Day Riche

Zinc Oxide And Octinoxate

NDC Product Code 46783-275

NDC Code: 46783-275

Proprietary Name: Micro Day Riche Additional informationCallout TooltipWhat 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: Zinc Oxide And Octinoxate Additional informationCallout TooltipWhat 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.


Code Structure
  • 46783 - Merz North America
    • 46783-275 - Micro Day Riche

NDC 46783-275-15

Package Description: 1 TUBE in 1 CARTON > 15 mL in 1 TUBE

NDC 46783-275-50

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

NDC Product Information

Micro Day Riche with NDC 46783-275 is a a human over the counter drug product labeled by Merz North America. The generic name of Micro Day Riche is zinc oxide and octinoxate. The product's dosage form is cream and is administered via topical form.

Labeler Name: Merz North America

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 Additional informationCallout TooltipWhat 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.


Micro Day Riche Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ZINC OXIDE 73 mg/mL
  • OCTINOXATE 75 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • HEXYLDECANOL (UNII: 151Z7P1317)
  • ISODODECANE (UNII: A8289P68Y2)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • HYDROGENATED PALM GLYCERIDES (UNII: YCZ8EM144Q)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TETRAPEPTIDE-21 (UNII: 179JUC43HU)
  • CAPRYLOYL SARCOSINE (UNII: BRL7HMB08G)
  • PALMITOYL TRIPEPTIDE-1 ACETATE (UNII: 99B84UAK70)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SQUALENE (UNII: 7QWM220FJH)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • STEARETH-21 (UNII: 53J3F32P58)
  • STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • MELAMINE (UNII: N3GP2YSD88)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Merz North America
Labeler Code: 46783
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 01-31-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Micro Day Riche Product Label Images

Micro Day Riche 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

Active Ingredients

Octinoxate 7.5% Zinc Oxide 7.3%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn and premature skin aging.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.Higher SPF gives more sunburn protection.

Warnings

For external use only.

Otc - Do Not Use

Do not use on damaged 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. See package insert for complete information.

Directions

  • Apply generously 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 Broad-Spectrum SPF value of 15 or higher and other sun protection measures including:-Limit time in the sun, especially from 10am - 2pm-Wear long-sleeved shirts, pants, hats, and sunglasses.Children under 6 months of age, ask a doctor

Inactive Ingredients

Aqua (Water, Eau), Hydrogenated Polyisobutene, Petrolatum, Caprylic/Capric Triglyceride, Hexyldecanol, Isododecane, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Potassium Cetyl Phosphate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydrogenated Palm Glycerides, Microcrystalline Cellulose, Dioscorea Villosa (Wild Yam) Root Extract, Camellia Sinensis Leaf Extract, Silica, Tetrapeptide-21, Capryloyl Carnosine, Palmitoyl Tripeptide-1 Acetate, Tocopheryl Acetate, Squalene, Sodium Hyaluronate, Cetearyl Alcohol, Steareth-21, Styrene/Acrylates Copolymer, Polysorbate 60, Butylene Glycol, Polysilicone-11, Xanthan Gum, Melanin, Sodium Ascorbyl Phosphate, Cellulose Gum, Disodium EDTA, Sorbitan Isostearate, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Phenoxyethanol, Methylparaben, Ethylparaben, Propylparaben.

Other Information

  • Protect this product from excessive heat and direct sun.

* Please review the disclaimer below.

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