Label: SUN DEFENSE CREAM- octinoxate titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated September 1, 2015

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  • Warning and Precautions Section

    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 SECTION

    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 SECTION

    ALOE VERA LEAF

    ALUMINUM STARCH OCTENYLSUCCINATE

    ASCORBIC ACID

    ASCORBYL PALMITATE

    BORON NITRIDE

    CAMELLIA SINENSIS FLOWER

    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES

    STEARYL ALCOHOL

    CETYL ALCOHOL

    CETEARYL ESONONANOATE

    CITRIC ACID MONOHYDRATE

    CITRUS AURANTIUM FLOWER OIL

    COCO-CAPRYLATE

    ETHYLHEXYLGLYCERIN

    GLYCERIN

    SUNFLOWER OIL

    NEACEN

    PANTHENOL

    PHENOXYETHANOL

    EGG PHOSPHOLIPIDS

    POTASSIUM SORBATE

    PROPANEDIOL

    ROSMARINUS OFFICINALIS FLOWERING TOP OIL

    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER

    SORBITAN STEARATE

    TOCOPHEROL

    GRAPE SEED OIL

    XANTHAN GUM

    WATER

  • OTC - ACTIVE INGREDIENT SECTION

    OCTINOXATE

    TITANIUM DIOXIDE

  • OTC - PURPOSE SECTION

  • keep out of reach of children section

    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.

  • PRINCIPAL DISPLAY PANEL

    image1

  • INGREDIENTS AND APPEARANCE
    SUN DEFENSE CREAM 
    octinoxate titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35192-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.372 g  in 0.375 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.372 g  in 0.375 g
    Inactive Ingredients
    Ingredient NameStrength
    HYALURONIC ACID (UNII: S270N0TRQY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    CAPRYLIC/CAPRIC MONO/DIGLYCERIDES (UNII: U72Q2I8C85)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETEARYL ISONONANOATE (UNII: P5O01U99NI)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACIN (UNII: 2679MF687A)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ROSMARINUS OFFICINALIS FLOWERING TOP OIL (UNII: OXN0D3N28L)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35192-022-099.3 g in 1 TUBE; Type 0: Not a Combination Product09/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/01/2015
    Labeler - CA-BOTANA INTERNATIONAL (106276728)
    Registrant - RODOLFO UGELSTAD (106276728)
    Establishment
    NameAddressID/FEIBusiness Operations
    CA-BOTANA INTERNATIONAL106276728manufacture(35192-022)
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