ROBANDA ANTI-AGING HAND (AVOBENZONE, OCTINOXATE, OCTISILATE AND OXYBENZONE) LOTION [ROBANDA INTERNATIONAL, INC.]

ROBANDA ANTI-AGING HAND (AVOBENZONE, OCTINOXATE, OCTISILATE AND OXYBENZONE) LOTION [ROBANDA INTERNATIONAL, INC.]
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NDC 53950-7007-1
Set ID 447135e8-5d2a-4d28-b629-b2d52e2f2c59
Category HUMAN OTC DRUG LABEL
Packager Robanda International, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • 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

    01b LBL_Anti-aging hand cream SPF

  • 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
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    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)  
    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
    OTC monograph not finalpart35211/02/2012
    Labeler - Robanda International, Inc. (048214287)

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