Label: FLAWLESS BY SONYA ALOE BB CREME SANDY- titanium dioxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 22, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient                                Purpose
    Titanium dioxide 7.04%.........................Sunscreen

  • PURPOSE

    Uses

    • helps prevent sunburn
  • WARNINGS

    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

    Do not use on damages or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove.

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    Directions

    • apply generously and evenly 15 minutes before sun exposure
    • reapply at least every 2 hours
    • use a water-resistant sunscreen if swimming or sweating
    • children under 6 months of age: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive ingredients
    water/aqua/eau, dimethicone, coco-caprylate, caprylic/capric tryglyceride, talc, dimethicone/vinyl dimethicone crosspolymer, cetyl peg/ppg 10/1 dimethicone, propanediol, iron oxide (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891), sorbitan olivate, glyceryl tribehenate/isostearate/eicosandioate, phenoxyethanol, stearalkonium hectorite, mica, alumina, sodium chloride, triethoxycaprylylsilane, sodium dehydroacetate, propylene carbonate, hydrogen dimethicone, aloe barbadensis leaf extract, spilanthes acmella flower extract, tin oxide, olea europaea (olive) leaf extract, fragrance/parfum, trisodium ethylenediamine disuccinate, alcohol, maltodextrin, tropolone, aluminum hydroxide, olea europaea (olive) fruit extract.

  • INDICATIONS & USAGE

    Other information

    • protect the product in the enclosed container from excessive heat and direct sun
    • For your protection, this carton has a clear safety seal on both top and bottom flaps
  • QUESTIONS

    Questions or comments?

    Call 1-888-440-2563, Monday-Friday, 9:00 am to 4:00 pm PT.

  • PRINCIPAL DISPLAY PANEL

    tubebox

  • INGREDIENTS AND APPEARANCE
    FLAWLESS BY SONYA ALOE BB CREME  SANDY
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11697-372
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.1680 g  in 45.0000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 18.8696 g  in 45.0000 g
    DIMETHICONE (UNII: 92RU3N3Y1O) 4.5923 g  in 45.0000 g
    COCO-CAPRYLATE (UNII: 4828G836N6) 2.9250 g  in 45.0000 g
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) 2.8359 g  in 45.0000 g
    TALC (UNII: 7SEV7J4R1U) 1.8630 g  in 45.0000 g
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 1.7438 g  in 45.0000 g
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 3) (UNII: G300307ZXP) 1.3500 g  in 45.0000 g
    PROPANEDIOL (UNII: 5965N8W85T) 1.3500 g  in 45.0000 g
    FERRIC OXIDE RED (UNII: 1K09F3G675) 0.3859 g  in 45.0000 g
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT) 0.3859 g  in 45.0000 g
    FERROSOFERRIC OXIDE (UNII: XM0M87F357) 0.3859 g  in 45.0000 g
    SORBITAN OLIVATE (UNII: MDL271E3GR) 0.9000 g  in 45.0000 g
    GLYCERYL TRIBEHENATE/ISOSTEARATE/EICOSANDIOATE (UNII: 3Y9NJ5Z7E5) 0.9000 g  in 45.0000 g
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.4365 g  in 45.0000 g
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P) 0.3375 g  in 45.0000 g
    MICA (UNII: V8A1AW0880) 0.3195 g  in 45.0000 g
    ALUMINUM OXIDE (UNII: LMI26O6933) 0.2340 g  in 45.0000 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.2250 g  in 45.0000 g
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) 0.1620 g  in 45.0000 g
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G) 0.1350 g  in 45.0000 g
    PROPYLENE CARBONATE (UNII: 8D08K3S51E) 0.1125 g  in 45.0000 g
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0450 g  in 45.0000 g
    ACMELLA OLERACEA FLOWER (UNII: 2794N5KM0K) 0.0441 g  in 45.0000 g
    STANNIC OXIDE (UNII: KM7N50LOS6) 0.0315 g  in 45.0000 g
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) 0.0313 g  in 45.0000 g
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q) 0.0167 g  in 45.0000 g
    ALCOHOL (UNII: 3K9958V90M) 0.0135 g  in 45.0000 g
    MALTODEXTRIN (UNII: 7CVR7L4A2D) 0.0135 g  in 45.0000 g
    TROPOLONE (UNII: 7L6DL16P1T) 0.0135 g  in 45.0000 g
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) 0.0134 g  in 45.0000 g
    BLACK OLIVE (UNII: 2M6QWV94OC) 0.0005 g  in 45.0000 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11697-372-021 in 1 CARTON
    1NDC:11697-372-0145 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2015
    Labeler - Aloe Vera of America, Inc. (049049463)
    Registrant - Aloe Vera of America, Inc. (049049463)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aloe Vera of America, Inc.049049463manufacture(11697-372)
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