NDC 73496-004 Roc Retinol Correxion Wrinkle Correct Daily Moisturizer Spf 30

Avobenzone, Homosalate, Octisalate

NDC Product Code 73496-004

NDC CODE: 73496-004

Proprietary Name: Roc Retinol Correxion Wrinkle Correct Daily Moisturizer Spf 30 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, Octisalate 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

  • 73496 - Roc Skincare
    • 73496-004 - Roc Retinol Correxion Wrinkle Correct Daily Moisturizer Spf 30

NDC 73496-004-01

Package Description: 30 mL in 1 TUBE

NDC Product Information

Roc Retinol Correxion Wrinkle Correct Daily Moisturizer Spf 30 with NDC 73496-004 is a a human over the counter drug product labeled by Roc Skincare. The generic name of Roc Retinol Correxion Wrinkle Correct Daily Moisturizer Spf 30 is avobenzone, homosalate, octisalate. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Roc Skincare

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.

Roc Retinol Correxion Wrinkle Correct Daily Moisturizer 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.

  • HOMOSALATE 10 mg/100mL
  • OCTISALATE 5 mg/100mL
  • AVOBENZONE 3 mg/100mL

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.

  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SQUALANE (UNII: GW89575KF9)
  • EDETOL (UNII: Q4R969U9FR)
  • ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CETETH-20 (UNII: I835H2IHHX)
  • LAURETH-7 (UNII: Z95S6G8201)
  • WATER (UNII: 059QF0KO0R)
  • DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
  • GLYCOLIC ACID (UNII: 0WT12SX38S)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ALLANTOIN (UNII: 344S277G0Z)
  • PEG-8 LAURATE (UNII: 762O8IWA10)
  • PEG-75 STEARATE (UNII: OT38R0N74H)
  • PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
  • PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
  • RETINOL (UNII: G2SH0XKK91)
  • P-ANISIC ACID (UNII: 4SB6Y7DMM3)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)

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: Roc Skincare
Labeler Code: 73496
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: 04-02-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Roc Retinol Correxion Wrinkle Correct Daily Moisturizer Spf 30 Product Label Images

Roc Retinol Correxion Wrinkle Correct Daily Moisturizer 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

Otc - Active Ingredient

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0 %.......Sunscreen

Uses

  • Helps prevent sunburnIf 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 onlyDo 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions For Sunscreen Use

  • Apply generously and evenly 15 minutes before sun exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweatingSun 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 sunglassesChildren under 6 months of age: Ask a doctor

Other Information

  • Protect this product from excessive heat, freezing and direct sunMay stain some fabricsStore between 20-25 °C (68-77 °F)

Inactive Ingredient

Water, Glycerin, Diethylhexyl 2,6-Naphthalate, Dimethicone, Tetrahydroxypropyl Ethylenediamine, Butylene Glycol, Cyclohexasiloxane, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, PPG-2 Myristyl Ether Propionate, Pentaerythrityl Tetraethylhexanoate, Squalane, Propanediol, Styrene/Acrylates Copolymer, Glyceryl Stearate, Aluminum Starch Octenylsuccinate, Retinol, Glycolic Acid, Tocopheryl Acetate, Ascorbyl Palmitate, Allantoin, p-Anisic Acid, Pentylene Glycol, Ceteth-20, Steareth-20, Polyacrylamide, PEG-8 Laurate, Laureth-7, C13-14 Isoparaffin, Ammonium Acryloyldimethyltaurate/VP Copolymer, PEG-75 Stearate, Cyclopentasiloxane, Polysorbate 20, Ascorbic Acid, Hydroxyphenyl Propamidobenzoic Acid, Caprylhydroxamic Acid, 1,2-Hexanediol, BHT, Disodium EDTA, Sodium Hydroxide, Fragrance.

Indications & Usage

  • Apply generously and evenly 15 minutes before sun exposureReapply at least every 2 hoursUse a water resistant sunscreen if swimming or sweatingSun 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 sunglassesChildren under 6 months of age: Ask a doctor

* Please review the disclaimer below.