JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [AUTUMN HARP, INC.]

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  • JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [AUTUMN HARP, INC.]

JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [AUTUMN HARP, INC.]
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NDC 51514-0332-1, 51514-0332-2, 51514-0332-3, 51514-0332-4
Set ID 027821e6-db7d-4c03-956a-00313488ebc7
Category HUMAN OTC DRUG LABEL
Packager Autumn Harp, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • BOXED WARNING (What is this?)

    Drug Facts

  • Active Ingredients

    Zinc Oxide 6.4%**

    Titanium Dioxide 5.1%**

  • Purpose

    Sunscreen

    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.

    Stop use and ask a doctor if rash occurs.

    When using this product

    · keep out of eyes 

    · rinse with water to remove

    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 2 hours

    • children under 6 months: Ask a doctor

  • WHEN USING

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a 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-sleeve shirts, pants, hats, and sunglasses

  • Inactive Ingredients:

    Aqua (Water)**, Ethylhexyl Palmitate, Caprylic/Capric

    Triglyceride**, Aloe Barbadensis Leaf Juice*, Polyglyceryl-6

    Polyricinoleate**, Cyclopentasiloxane, Polysilicone-11,

    Argania Spinosa (Argan) Kernel Oil**, Glycerin**, Cera Alba

    (Beeswax)*, Coco-Caprylate/Caprate, Phenoxyethanol,

    Polyhydroxystearic Acid, Methicone, Alumina, Tocopheryl

    Acetate, Sodium Chloride**, Triethoxycaprylylsilane,

    Polyglyceryl-10 Laurate, Parfum (Fragrance)**, Bisabolol,

    Dimethicone, Simmondsia Chinensis (Jojoba) Seed Oil*,

    Laureth-12, Ethylhexylglycerin, Camellia Sinensis (Green

    Tea) Leaf Extract*, Citric Acid**, Potassium Sorbate**,

    Sodium Benzoate**.

    *ORGANIC **NATURAL

  • Other Information:

    · Protect this product from excessive heat and direct sun.

  • Principle Display Panel

    15 ml carton15 ml label\ 120 ml carton60 ml carton5 ml carton5 ml label120 ml label60 ml labelImage Components

  • INGREDIENTS AND APPEARANCE
    JOSIE MARAN ARGAN DAILY MOISTURIZER SPF47 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0332
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE6.4 mg  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5.1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYGLYCERYL-6 DIOLEATE (UNII: 062SZD3F3X)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    APRICOT (UNII: 269CJD5GZ9)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LAURETH-12 (UNII: OAH19558U1)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LIMONENE, (+/-)- (UNII: 9MC3I34447)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0332-15 mL in 1 TUBE; Type 0: Not a Combination Product01/24/2014
    2NDC:51514-0332-215 mL in 1 TUBE; Type 0: Not a Combination Product01/24/2014
    3NDC:51514-0332-360 mL in 1 TUBE; Type 0: Not a Combination Product01/24/2014
    4NDC:51514-0332-4120 mL in 1 TUBE; Type 0: Not a Combination Product01/24/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/09/2014
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(51514-0332)
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