Label: TINTED BB- octinoxate and titanium dioxide cream

  • 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 December 27, 2017

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  • Active Ingredients

    Octyl Methoxycinnamate 6%

    Titanium Dioxide 8.5%

  • Purpose

    Sunscreen

    Sunscreen

  • Use

    helps prevent sunburn

  • Warnings

    Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.

    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 call a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use water resistant sunscreen if swimming or seating
    • children under 6 months: ask a doctor
  • Other information

    • protect this product from excessive heat and direct sun
  • Inactive Ingredients

    water, proylene glycol, glycerin, cyclo pentasiloxane, cetyl ethylhexanoate, niacinamide, polysorbate 60, stearic acide, cyclohexasiloxane, glyceryl stearate, cetyl alcohol, sorbitan sesquioleate, dimethicone, triethanolamine, dimethiconol, magnesium aluminum silicate, cl 19140, triethoxycaprylylsilane, betaine, cl 77492, methyparaben, cl 77491, xanthan gum, allantoin, propylparaben, disodium EDTA, cl 77499, tocopheryl acetate, adenosine,

  • Package label

    BB Cream

    image of sunscreen tube

  • INGREDIENTS AND APPEARANCE
    TINTED BB 
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0378
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 mg  in 100 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE8.5 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    BETAINE (UNII: 3SCV180C9W)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    ADENOSINE (UNII: K72T3FS567)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0378-340 mg in 1 TUBE; Type 0: Not a Combination Product10/11/2013
    2NDC:67510-0378-130 mg in 1 TUBE; Type 0: Not a Combination Product10/11/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35210/11/2013
    Labeler - Kareway Product, Inc. (121840057)
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