Label: YES TO GRAPEFRUIT CC CREAM - LIGHT- zinc oxide, 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 12, 2013

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  • WARNINGS AND PRECAUTIONS

    Drug Facts

  • Active Ingredients:

    Zinc Oxide (3.2%) Titanium Dioxide (2.9%)

  • Purpose:

    Sunscreen

  • Uses:

    Helps prevent sunburn • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • 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 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.

  • Directions:

    Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every two hours. Children under 6 months: Ask a doctor.

    Sun Protection Measure Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sun-glasses.

  • Inactive Ingredients

    Water, Ethylhexyl Palmitate, Helianthus Annuus (Sunflower) Seed Oil, Glycerin, Cetearyl Alcohol, Caprylic/Capric Triglyceride, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Magnesium Aluminum Silicate, Propanediol, Coco-Glucoside, Zea Mays (Corn) Starch*, Citrus Grandis (Grapefruit) Peel Extract*, Moringa oleifera seed oil, Evodia Rutaecarpa Fruit Extract, Phenethyl Alcohol, Cetyl Alcohol, Fragrance, Glyceryl Caprylate, Xanthan Gum, Glyceryl Isostearate, Hydrated Silica, Glycine Soja (Soybean) Oil, Tocopherol, Cyamopsis Tetragonoloba (Guar) Gum*, Disodium Carboxyethyl Siliconate, Citric Acid, Limonene, Aluminum Hydroxide, Polyhydroxystearic Acid, Trihydroxystearin, Triethoxycaprylylsilane, Potassium Hydroxide, Titanium Dioxide, Iron Oxides. * Certified Organic Ingredient

  • Questions?

    1-888-92-Yes-To (1-888-929-3786) or visit www.yestocarrots.com

  • Other information

    Protect this product from excessive heat and direct sun.

  • Principal Display Panel

    carton

    Image Componentscomponent

  • INGREDIENTS AND APPEARANCE
    YES TO GRAPEFRUIT CC CREAM - LIGHT 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0325
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.2 mg  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.9 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    PHENETHYL ALCOHOL (UNII: ML9LGA7468)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIHYDROXYSTEARIN (UNII: 06YD7896S3)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    TETRADIUM RUTICARPUM FRUIT (UNII: Q413WWJ3X9)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GUAR GUM (UNII: E89I1637KE)  
    DISODIUM CARBOXYETHYL SILICONATE (UNII: 4U4C79679G)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    GRAPEFRUIT PEEL (UNII: 3582N05Q44)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0325-150 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/15/2013
    Labeler - Autumn Harp, Inc (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc064187883manufacture(51514-0325)
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