Label: ROBANDA ANTI-AGING HAND- avobenzone, octinoxate, octisalate, oxybenzone lotion

  • NDC Code(s): 53950-7007-1
  • Packager: Robanda International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 13, 2024

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

View All Sections
  • Active ingredient

    Avobenzone (1%)

    Octinoxate (7.5%)

    Octisilate (5%)

    Oxybenzone (6%)

  • Purpose

    Sunscreen

  • Keep Out of Reach of Children

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    • Helps treat and prevent aging of the hands
    • Reduces freckle spots, wrinkles, & fine lines
    • Skin lightener with anti-aging and antioxidant properties
  • Warnings

    For external use only.

    When using this product

    • Keep out of eyes. Rinse with water to remove.

    Stop use and ask doctor if

    • Rash or irritation develops and lasts.
  • Directions

    Apply to hands twice daily, or as desired.

  • Inactive ingredients

    Water, Dimethicone, Glycerin, C12-15 Alkyl Benzoate, Stearic Acid, Glyceryl Stearate, Cetyl Alcohol, Dimethyl Capramide, PEG-100 Stearate, Triethanolamine, Phyllanthus Embilica (Fruit) Extract, Hydroxylated Soy Lethicin, Carbomer, Retinyl Acetate, Retinol, Tetrasodium EDTA, Tocopherol Acetate, Tocopherol, Squalane, Butyrospermum Parkii (Shea Butter), Phenoxyethanol, Hydroxyethyl Acrylate/Sodium Acryloyl Dimethyltaurate Copolymer, Ethylhexylglycerin, Polysorbate 60, Titanium Dioxide, Yellow 5 (CI 19140), Red 40 (CI 16035)

    Robanda International, Inc.

    San Diego, CA, 92110, U.S.A.

    Edgware, Middx, HA8 9TA, U.K.

    P:(800) 783.9969

    P:(619) 276.7660

    F:(619) 276.7661

    www. robanda.com

  • PRINCIPAL DISPLAY PANEL

    ro20

  • INGREDIENTS AND APPEARANCE
    ROBANDA ANTI-AGING HAND 
    avobenzone, octinoxate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53950-7007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1 mg  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 mg  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 mg  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHYL CAPRAMIDE (UNII: O29Y6X2JEZ)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)  
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY)  
    RETINOL (UNII: G2SH0XKK91)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SQUALANE (UNII: GW89575KF9)  
    SHEANUT OIL (UNII: O88E196QRF)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53950-7007-190 mL in 1 TUBE; Type 0: Not a Combination Product11/02/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/02/2012
    Labeler - Robanda International, Inc. (048214287)
    Registrant - Westwood Laboratories, LLC (832280635)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!