Label: ALOE SUN BB SPF20 PA PLUS NUMBER1 NATURAL SKIN- 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 September 23, 2011

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  • ACTIVE INGREDIENT

    Active ingredients: TITANIUM DIOXIDE 7.73%, OCTINOXATE 3%

  • INACTIVE INGREDIENT

    Inactive ingredients:
    WATER, CYCLOPENTASILOXANE, CETYL PEG/PPG-10/1 DIMETHICONE, BUTYLENE GLYCOL, POLYMETHYL METHACRYLATE, CERESIN, BORON NITRIDE, SORBITAN ISOSTEARATE, SODIUM CHLORIDE, DIMETHICONE, PHENYL TRIMETHICONE, SORBITAN OLIVATE, SILICA, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, ALOE BARBADENSIS LEAF EXTRACT, TRIMETHYLSILOXYSILICATE, ALUMINUM HYDROXIDE, STEARIC ACID, TRIETHOXYCAPRYLYLSILANE, TALC, METHYLPARABEN, PHENOXYETHANOL, PROPYLPARABEN, FRAGRANCE, IRON OXIDES (CI 77492), IRON OXIDES (CI 77499), ULTRAMARINES (CI 77007), IRON OXIDES (CI 77491)

  • PURPOSE

    Purpose: UVA/UVB protection (SPF20 PA+)

  • WARNINGS

    Warnings:
    For external use only.
    Avoid contact with eyes.
    Discontinue use if signs of irritation appear.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indication and usage:
    After your daily skin care regimen, apply an even layer onto the face in upward and outward motions.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Dispense an ample amount and apply a thin layer onto the skin.
    For maximum coverage, reapply the BB cream on hyper pigmentation areas.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ALOE SUN BB  SPF20 PA PLUS NUMBER1 NATURAL SKIN
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-028
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE3.86 g  in 50 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.5 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CERESIN (UNII: Q1LS2UJO3A)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-028-0150 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/01/2011
    Labeler - SKINFOOD CO., LTD. (690324173)
    Registrant - SKINFOOD CO., LTD. (690324173)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINFOOD CO., LTD.690324173manufacture
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