Label: UMBRELLA SUNSCREEN- octinoxate titanium dioxide lotion

  • NDC Code(s): 35192-010-02
  • Packager: CA-BOTANA INTERNATIONAL
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 16, 2023

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  • 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 product is swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 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-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

  • INACTIVE INGREDIENT

    ALOE VERA LEAF, ALUMINUM STARCH OCTENYLSUCCINATE, ASCORBIC ACID, ASCORBYL PALMITATE, BORON NITRIDE, CETOSTEARYL ALCOHOL, CETEARYL ISONONANOATE, CITRIC ACID MONOHYDRATE, CAPRYLIC/CAPRIC MONO/DIGLYCERIDES, ETHYLHEXYLGLYCERIN, GLYCERIN, SUNFLOWER OIL, ISOMALT, LECITHIN SOYBEAN, MACADAMIA OIL, NIACIN, PANTHENOL, PHENOXYETHANOL, LECITHIN SOYBEAN, POTASSIUM SORBATE, PROPANEDIOL, ROSA MOSCHATA OIL, ROSEMARY, SODIUM BENZOATE, HYALURONATE SODIUM, TETRASODIUM IMINODISUCCINATE, TOCOPHEROL, GRAPE SEED OIL, WATER

  • PURPOSE

    Sunscreen

  • ACTIVE INGREDIENT

    Titanium Dioxide, Octinoxate

  • KEEP OUT OF REACH OF CHILDREN

    For external use only.
    Avoid contact with eyes.
    Keep out of reach of children.
    Do not apply to open wounds.
    STOP USE AND ask a doctor if condition worsens or
    symptoms persist for more than seven days, discontinue
    use of the product.

  • INDICATIONS & USAGE

    Helps prevent sunburn. If used as directed with other sun protection measured decreases the risk of skin cancer and early skin aging caused by the sun. Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply: at least 2 hours. Children under 6 months: Ask a doctor. Sun protection measurements. 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 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-sleeve shirts, pants, hats, and sunglasses. Protect this product from excessive heat and direct sun

  • Package label principal display panel

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  • INGREDIENTS AND APPEARANCE
    UMBRELLA SUNSCREEN 
    octinoxate titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.8 g  in 113.4 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE8.5 g  in 113.4 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISOMALT (UNII: S870P55O2W)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    NIACIN (UNII: 2679MF687A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ROSA MOSCHATA OIL (UNII: J99W255AWF)  
    ROSEMARY (UNII: IJ67X351P9)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TETRASODIUM IMINODISUCCINATE (UNII: GYS41J2635)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35192-010-02113.4 g in 1 TUBE; Type 0: Not a Combination Product11/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/01/2012
    Labeler - CA-BOTANA INTERNATIONAL (106276728)
    Registrant - RODOLFO UGELSTAD (106276728)
    Establishment
    NameAddressID/FEIBusiness Operations
    CA-BOTANA INTERNATIONAL106276728manufacture(35192-010)
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