YES TO GRAPEFRUIT MOISTURIZER WITH SPF15 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [AUTUMN HARP, INC.]

YES TO GRAPEFRUIT MOISTURIZER WITH SPF15 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [AUTUMN HARP, INC.]
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NDC 51514-0317-1
Set ID dd644453-e0ef-49df-8619-e751c5b2ba38
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 (3.2%), Titanium Dioxide (2.9%)

  • Purpose

    Sunscreen

    Uses  Helps prevent sunburn • Higher SPF gives more sunburn protection • Provides high protection against sunburn

  • Warnings:

    For external use only • When using this product, avoid contact with eyes • If contact occurs, rinse with water to remove • Stop use and ask a doctor if rash or irritation develops and lasts • Keep out or reach of children; if swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    Apply liberally 15 minutes before sun exposure.  Ues 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

  • Principal display panel

    Image Components

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    YES TO GRAPEFRUIT MOISTURIZER WITH SPF15 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0317
    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)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PHENETHYL ALCOHOL (UNII: ML9LGA7468)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MORINGA OLEIFERA SEED OIL (UNII: REM6A5QMC0)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    GRAPEFRUIT (UNII: O82C39RR8C)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    GUAR GUM (UNII: E89I1637KE)  
    CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorGRAPEFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0317-141 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/14/2012
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0317)

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