YES TO BLUEBERRIES DAILY REPAIRING MOISTURIZER SPF30 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [AUTUMN HARP, INC.]

YES TO BLUEBERRIES DAILY REPAIRING MOISTURIZER SPF30 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [AUTUMN HARP, INC.]
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NDC 51514-0322-1
Set ID 0dbdea5b-6d4c-4c0f-8e82-e02c287088a5
Category HUMAN OTC DRUG LABEL
Packager Autumn Harp, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • WARNINGS AND PRECAUTIONS

    Drug Facts

  • Active Ingredients

    Zinc Oxide (11%), Titanium Dioxide (6.2%)

  • 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 10am - 2pm. Wear long sleeved shirts, pants, hats and sun-glasses.

  • Inactive Ingredients

    Water, Ethylhexyl Palmitate, Hydrogenated Methyl Abietate, Glyceryl Stearate Citrate, Glycerin, Magnesium Aluminum Silicate, Aluminum Hydroxide, Cetearyl Alcohol, Phenethyl Alcohol, Alcohol, Sodium Magnesium Silicate, Glyceryl Caprylate, Vaccinium Cyanococcus (Blueberry) Fruit Juice, Xanthan Gum, Hydrated Silica, Triethoxycaprylylsilane, Tocopherol, Limonene, Fragrance, Onopordum Acanthium Flower/Leaf/Stem Extract, Linalool, Aloe Barbadensis Leaf Juice*, Linalool, Citral, Geraniol, Citronellol. * Certified Organic Ingredient

  • Principal Display Panel

    Image ComponentsComponent artworkCarton artwork

  • INGREDIENTS AND APPEARANCE
    YES TO BLUEBERRIES DAILY REPAIRING MOISTURIZER SPF30 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0322
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.0 mg  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    WATER (UNII: 059QF0KO0R)  
    HYDROGENATED METHYL ABIETATE (UNII: A23O709X8O)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENETHYL ALCOHOL (UNII: ML9LGA7468)  
    ALCOHOL (UNII: 3K9958V90M)  
    LAPONITE (UNII: D703131383)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ONOPORDUM ACANTHIUM FLOWERING TOP (UNII: 475866K8C4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CITRAL (UNII: T7EU0O9VPP)  
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0322-141 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35203/22/2013
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0322)

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