Label: ROC RETINOL CORREXION WRINKLE CORRECT DAILY MOISTURIZER SPF 30- avobenzone, homosalate, octisalate lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 20, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions for Sunscreen use

    • Apply generously and evenly 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, freezing and direct sun
    • May stain some fabrics
    • Store 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.

  • Questions or Comments?

    Call toll free 1-800-RoC-1964 (1-800-762-1964) or 215-273-8755 (collect).

  • INDICATIONS & USAGE

    • Apply generously and evenly 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
  • PRINCIPAL DISPLAY PANEL

    Label Artwork-Carton

  • INGREDIENTS AND APPEARANCE
    ROC RETINOL CORREXION WRINKLE CORRECT DAILY MOISTURIZER SPF 30 
    avobenzone, homosalate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73496-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 mg  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    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)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    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)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    RETINOL (UNII: G2SH0XKK91)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73496-004-0130 mL in 1 TUBE; Type 0: Not a Combination Product04/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/02/2021
    Labeler - Roc Skincare (117157981)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermaceutical Laboratories Limited Liability Company078457159manufacture(73496-004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Amcol Health & Beauty Solutions, Incorporated872684803manufacture(73496-004)